[Federal Register Volume 67, Number 25 (Wednesday, February 6, 2002)]
[Rules and Regulations]
[Pages 5446-5469]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-2750]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16 and 900

[Docket No. 99N-4578]
RIN 0910-AB98


State Certification of Mammography Facilities

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations governing mammography. The amendments implement the 
``States as Certifiers'' (SAC) provisions of the Mammography Quality 
Standards Act of 1992 (MQSA). These amendments permit FDA to authorize 
individual States to certify mammography facilities, conduct facility 
inspections, enforce the MQSA quality standards, and administer other 
related functions. The amendments establish the standards to be met by 
States receiving this authority. They also establish procedures for 
application, approval, evaluation, and withdrawal of approval of States 
as certification agencies. FDA retains oversight responsibility for the 
activities of the States to which this authority is given. Mammography 
facilities certified by those States must continue to meet the quality 
standards established by FDA for mammography facilities nationwide.

DATES: This rule is effective May 7, 2002. Submit written comments on 
the information collection requirements by March 8, 2002.

ADDRESSES: Submit written comments on the information collection 
requirements to the Office of Information and Regulatory Affairs, 
Office of Management and Budget (OMB), New Executive Office Bldg., 725 
17th St. NW., rm. 10235, Washington, DC 20503, Attn: Wendy A. Taylor, 
Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Kaye F. Chesemore, Center for Devices 
and Radiological Health (HFZ-240), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-594-3332, FAX 301-594-3306.

SUPPLEMENTARY INFORMATION:

I. Background

    MQSA (Public Law 102-539) was enacted on October 27, 1992. The 
purpose of the legislation was to establish minimum national quality 
standards for mammography. To provide mammography services legally 
after October 1, 1994, MQSA requires all mammography facilities, except 
facilities of the Department of Veterans Affairs, to be accredited by 
an approved accreditation body and certified by the Secretary of Health 
and Human Services (the Secretary). The authority to approve 
accreditation bodies and to certify facilities was delegated by the 
Secretary to FDA. MQSA replaced a patchwork of Federal, State, and 
private standards with uniform minimum Federal standards designed to 
ensure that all women nationwide receive adequate quality mammography 
services. On October 9, 1998, the Mammography Quality Standards 
Reauthorization Act (MQSRA) (Public Law 105-248) was enacted to extend 
MQSA through fiscal year (FY) 2002.

A. Provisions of MQSA

    In order to receive and maintain FDA certification, facilities must 
meet key requirements of MQSA, which include:
    1. Compliance with quality standards for personnel, equipment, 
quality assurance programs, and reporting and recordkeeping procedures.
    2. Accreditation by private, nonprofit organizations or State 
agencies that have been approved by FDA as meeting MQSA standards for 
accreditation bodies and that continue to pass annual FDA performance 
evaluations of their activities. As part of the accreditation process, 
the accreditation body must evaluate actual clinical mammograms from 
each unit in the facility for quality. The accreditation body 
determines whether or not the facility quality standards have been met.
    3. Demonstration of continued compliance with the facility quality 
standards through annual inspections performed by FDA-certified Federal 
or State inspectors.

B. Accomplishments to Date

    Interim facility quality standards were published in the Federal 
Register of December 21, 1993 (58 FR 67558), and used as the basis for 
the initial certification of mammography facilities under MQSA 
beginning October 1, 1994. By that date, mammography facilities had to 
have a FDA certificate in order to continue to lawfully provide 
mammography services. In the Federal Register of October 28, 1997 (62 
FR 55852), more comprehensive facility quality standards and 
accreditation body requirements were published and became effective on 
April 28, 1999. FDA has approved five accreditation bodies: American 
College of Radiology (ACR) and the States of Arkansas, California, 
Iowa, and Texas. The number of certified mammography facilities varies 
with time but typically is about 10,000. FDA has trained and certified 
Federal and State inspectors to conduct MQSA inspections, and the sixth 
year of inspections is underway.

C. Standards for Certification Agencies

    State agencies have played a very important role in the development 
and implementation of the MQSA program. As already noted, four of the 
five accreditation bodies are States, thus providing an alternative to 
the ACR for accreditation of facilities within those four States. Most 
of the FDA-certified inspectors are State personnel who, under contract 
with FDA, have conducted the great majority of MQSA inspections. FDA 
currently has contracts for the performance of inspections with 47 
States, the District of Columbia, Puerto Rico, and New York City. 
Mammography facilities in States without inspection contracts and all 
Federal facilities are generally inspected by FDA.
    MQSA also provides for an even more significant State role in the 
MQSA program. Section 354(q) of the Public Health Service Act (the PHS 
Act) (42 U.S.C. 263b(q)) permits FDA to authorize qualified States to: 
(1) Issue, renew, suspend, and revoke certificates;

[[Page 5447]]

(2) conduct annual facility inspections and followup inspections; and 
(3) implement and enforce the MQSA quality standards for mammography 
facilities operating within the qualified State. This rule puts into 
effect 42 U.S.C. 263b(q) by establishing the requirements that must be 
met by the States acting as certification agencies (commonly known as 
SACs) and the procedures for the application, approval, evaluation, and 
withdrawal of approval of SACs.
    To be approved as a certification agency, a State must: (1) Have 
enacted laws and issued regulations at least as stringent as the MQSA 
standards and regulations, (2) have the legal authority and qualified 
personnel to enforce those laws and regulations, (3) devote adequate 
funds to the administration and enforcement of those laws and 
regulations, and (4) provide FDA with information and reports, as 
required.
    By statute, FDA and SAC States each have authority in the areas of 
compliance and the suspension or revocation of certificates. Should 
there ever be a need, FDA is able to take administrative, judicial, or 
other actions against facilities within an approved State, regardless 
of whether a State takes such action. FDA retains exclusive 
responsibility for: (1) Establishing quality standards, (2) approving 
and withdrawing approval of accreditation bodies, (3) approving and 
withdrawing approval of State certification agencies, and (4) 
maintaining oversight of State certification programs.

D. Development of the SAC Proposed Rule

    In the Federal Register of March 30, 2000 (65 FR 16847), FDA 
published a proposed rule for the implementation of the SAC provisions 
of MQSA and sought public comment. FDA's National Mammography Quality 
Assurance Advisory Committee (NMQAAC) and a SAC working group aided in 
the development of the proposed rule.
    NMQAAC is a committee of health professionals and representatives 
of consumer groups and State agencies with responsibility for advising 
FDA on regulatory requirements implemented under MQSA. NMQAAC provided 
advice about the direction of the SAC program and the content of the 
proposed rule at meetings held in September 1994 and July 1996.
    FDA's partnership with the States will be an essential key to the 
future success of the SAC program. To begin building that partnership, 
FDA formed a working group in accordance with 21 CFR 20.88(e). Working 
group participants have included regional and headquarters FDA staff, 
representatives of the States of Arkansas, California, Florida, 
Illinois, Iowa, Massachusetts, Nevada, New Hampshire, New Jersey, and 
Texas, and the American College of Radiology. FDA chose the State 
participants with the goal of obtaining input from all regions of the 
country and from States that are MQSA accreditation bodies. Since its 
first meeting in June 1996, the working group has contributed greatly 
to the development of the proposed rules.
    The agency has also utilized knowledge gained from its experience 
in working with the accreditation bodies over the past several years 
and from a SAC Demonstration Project. Experience with the accreditation 
bodies has greatly influenced the proposed rule because of the 
similarity to the: (1) Objectives targeted, (2) problems to be solved, 
and (3) agency oversight needed.
    The SAC Demonstration Project, established by FDA in August 1998, 
gave certification authority to approved States for a 1-year trial 
period that was later extended for a second and third year. The States 
of Illinois and Iowa applied for and received approval from FDA to 
participate in the SAC Demonstration Project. The experience proved 
valuable in the development of the national regulatory SAC program.
    The proposed rule's 90-day comment period ended on June 28, 2000. 
FDA analyzed the comments received and responds to them in sections 
III, V, and VI of this document. As noted, FDA made some changes to the 
proposed rule in response to those comments.

II. Provisions of the Final Rule

    FDA is adding subpart C, entitled ``States as Certifiers,'' to part 
900 (21 CFR part 900--Mammography). This subpart contains sections 
defining: (1) The requirements for a State to apply to become a 
certification agency, (2) the requirements to be met by and the 
responsibilities of the States that receive certification authority, 
(3) the processes to be used by FDA in evaluating the performance of 
each certification agency, (4) the criteria for and the process to be 
followed to withdraw approval of a certification agency, and (5) the 
opportunities for hearings and appeals related to adverse actions taken 
by FDA with respect to certification agencies. FDA is also amending 
Sec. 16.1(b)(2) (21 CFR 16.1(b)(2)), which addresses hearing 
procedures, and Sec. 900.2 (Definitions) to bring the regulations into 
conformance with subpart C.
    The intent of MQSA, which is to assure high quality mammography 
services for all women in the United States, led FDA to add subpart C. 
FDA believes that these amendments will provide women, in States with 
certification authority, with the same assurance of high quality 
mammography as women in States for which FDA retains that authority. 
There are also potential cost savings to the facilities and the public 
through a reduction in the facility inspection fees in SAC States. This 
will occur in SAC States whose inspection costs are lower than the 
national average that is used to calculate the present national 
inspection fee.

A. Scope

    Section 900.20 describes the scope of subpart C. The new subpart 
establishes procedures for a State to apply to become a FDA-approved 
certification agency for mammography facilities. It further defines the 
responsibilities to be met by certification agencies and the oversight 
procedures that FDA will use to ensure that these responsibilities are 
met.

B. Application for Approval as a Certification Agency

    Section 900.21 summarizes the information to be provided by the 
State to enable FDA to make an informed decision about the State's 
ability to adequately carry out certification responsibilities. The 
application must include a detailed description of the mammography 
quality standards the applicant will require facilities to meet. If 
these standards are different from FDA's quality standards, the 
application must include information to show that they are at least as 
stringent as FDA standards. The application also must include 
information about the applicant's decisionmaking process for issuing, 
suspending, and revoking a facility's certificate as well as its 
procedures for notifying facilities of inspection deficiencies and the 
monitoring of the correction of those deficiencies. Finally, the State 
must provide information about the resources it can devote to the 
program, including the: (1) Qualifications of the State's professional 
staff; (2) adequacy of the State's staffing, finances, and other 
resources; (3) ability of the State to provide data and reports in an 
electronic format compatible with FDA data systems; and (4) adequacy of 
the State's enforcement authority and compliance mechanisms.
    Section 900.21(c) provides a general description of the process 
that FDA will follow to decide whether or not to accept a State as a 
certification agency. Section 900.21(d) notes that FDA may limit the 
types of facilities for which

[[Page 5448]]

FDA is granting certification authority; for example, FDA does not 
expect to grant certification authority to States for Federal 
facilities. It should be noted also that 42 U.S.C. 263b(q) does not 
permit FDA to grant a State authority to certify facilities outside of 
the State's borders.

C. Standards for Certification Agencies

    Section 900.22 establishes the requirements and responsibilities to 
be met by States that have been approved as certification agencies.
    Section 900.22(a) requires the certification agency to have FDA-
approved measures to reduce the possibility of conflict of interest or 
facility bias on the part of individuals acting on the agency's behalf.
    Section 900.22(b) requires that the statutory and regulatory 
requirements used by the certification agencies for the certification 
and inspection of mammography facilities be those established by FDA in 
part 900 or other appropriate, but at least as stringent, requirements.
    Section 900.22(c) requires that the scope, timeliness, disposition, 
and technical accuracy of completed inspections and related enforcement 
activities conducted by the certification agencies be adequate to 
ensure compliance with the MQSA quality standards.
    Section 900.22(d) requires that the certification agencies have 
appropriate criteria and processes for the suspension and revocation of 
certificates and that the certification agencies promptly investigate 
and take regulatory action against facilities that operate without a 
certificate.
    Section 900.22(e) requires that there be means by which facilities 
can appeal adverse certification decisions made by a certification 
agency.
    Section 900.22(f) requires that approved certification agencies 
have processes for requesting additional mammography review from 
accreditation bodies for issues related to mammography image quality 
and clinical practice.
    Section 900.22(g) requires that the certification agencies have 
procedures for patient and physician notification in situations where 
the certification agency has determined that mammography quality has 
been compromised to the extent that there may be a serious risk to 
human health.
    Section 900.22(h) requires that certification agencies have 
processes to ensure the timeliness and accuracy of electronic 
transmission of inspection data and facility certification information 
in a format and timeframe determined by FDA.
    Section 900.22(i) requires FDA authorization for any changes a 
certification agency proposes to make in any standards that FDA 
previously accepted under Sec. 900.21 or Sec. 900.22. FDA believes that 
this process is necessary to assure that standards for certification 
agencies remain at least as stringent as the FDA standards.

D. Evaluation

    Section 900.23 establishes standards for the annual performance 
evaluation of each certification agency. The evaluation will be based 
on indicators related to the adequacy of the certification agency's 
performance in the areas of certification, inspection, and compliance.
    During the evaluation, FDA will consider the timeliness and 
effectiveness with which the certification agencies meet their various 
responsibilities. The evaluation also will include a review of any 
changes in the standards or procedures that the certification agency 
has made in the areas listed in Secs. 900.21(b) and 900.22. The 
evaluation will include a determination of whether there are major 
deficiencies in the certification agency's performance that, if not 
corrected, would warrant FDA withdrawal of the State agency's approval. 
The evaluation will also include identification of any minor 
deficiencies that require corrective action.

E. Withdrawal of Approval

    Section 900.24 provides for the actions to be taken if evaluations 
carried out under Sec. 900.23, or other information, leads FDA to 
determine that a State certification agency is not adequately carrying 
out its responsibilities. If FDA determines that there are major 
deficiencies in the certification agency's performance, FDA may 
withdraw its approval. Examples of major deficiencies include: (1) 
Commission of fraud, (2) willful disregard for the public health, (3) 
failure to provide adequate resources for the program, (4) performing 
or failing to perform a delegated function in a manner that may cause 
serious risk to the public health, or (5) the submission of material 
false statements to FDA.
    For minor or less serious deficiencies, FDA will establish a 
definite time period for the certification agency to take corrective 
measures as directed by FDA or to submit the State's own plan of 
corrective action for FDA approval. FDA may place the certification 
agency on probationary status while the agency is addressing the minor 
deficiencies. The agency would utilize probationary status in 
situations where the certification agency is not implementing the 
corrective action satisfactorily or within the established schedule. 
FDA also may withdraw approval from the certification agency if: (1) 
Corrective action is not taken or (2) the identified minor deficiencies 
have not been eliminated within the established timeframe.
    While a certification agency is developing and carrying out its 
corrective action plan, even if on probationary status, it will retain 
its certification authority. If a certification agency loses its 
approval, it must notify all facilities certified or seeking 
certification by it. In addition, the certification agency must notify 
the appropriate accreditation bodies with jurisdiction in the State of 
its change in status. These requirements, however, would not preclude 
FDA notification. A certification agency that has lost its approval 
must also transfer facility records and other information required by 
FDA to a location and according to a schedule approved by FDA.

F. Hearings/Appeals

    Under Sec. 900.25, FDA provides an opportunity for a certification 
agency to challenge in an informal hearing an adverse action taken by 
FDA with respect to approval or withdrawal of approval. The agency 
provides the opportunity for a hearing in accordance with part 16 (21 
CFR part 16). Certification agencies also are required to provide 
facilities that have been denied certification with the opportunity to 
appeal that decision. Each certification agency shall specify in 
writing its appeals process for approval by FDA in accordance with 
Sec. 900.21.

G. Conforming Amendments

    A conforming amendment to Sec. 16.1 adds Sec. 900.25 to the list of 
provisions under which regulatory hearings are available.
    Conforming amendments to Sec. 900.2 state that the definitions in 
that section apply to subpart C, as well as to subparts A and B of part 
900. Three definitions, ``Sec. 900.2 (zz) Certification agency,'' 
``(aaa) Performance indicator,'' and ``(bbb) Authorization'' are added 
to the definition list. In adding these definitions, FDA departs from 
its earlier practice of placing the definitions in alphabetical order 
to add the new definitions to the end of the list. This placement was 
done to avoid the necessity of making numerous changes in the citations 
of the definitions in subparts A and B and to avoid the potential for 
confusion and error. A

[[Page 5449]]

change has also been made in the definition of ``Certification'' to 
recognize the role of States as certification agencies. A similar 
conforming amendment was made to Sec. 900.11(a).

III. Public Comments on Provisions of the Final Rule

    FDA received eight responses to the request for comments on the 
proposed regulations for State certification of mammography facilities. 
They were from representatives of a mammography facility, the ACR, the 
Conference of Radiation Control Program Directors, Inc. (CRCPD), and 
five representatives of individual State radiation control programs. 
Each response contained a number of individual comments. A large number 
of these comments were related to the cost analysis and will be 
addressed in section V of this document (Analysis of Impacts). A few of 
the comments dealt with paperwork issues and will be discussed in 
section VIII of this document (Paperwork Reduction Act of 1995). The 
remaining comments addressed: (1) The general concept of SAC, (2) 
individual provisions of the proposed regulations, and (3) possible 
additions to the regulations. FDA responds to these comments as 
follows.

A. General Comments

    General comments were those that raised issues or concerns that 
were broader in scope than any specific provisions.
    (Comment 1) One comment reminded FDA that ``MQSA was established to 
create and maintain a minimum national quality standard in 
mammography.'' The authors went on to laud the ``strict requirements'' 
and the procedures of the agency for their effectiveness in achieving 
this goal. However, they expressed concerns about continuing to meet 
the intent of MQSA in a consistent fashion without undue burdens on 
facilities if certification authority was given to a number of agencies 
(States). Although the authors did not appear to be opposed in 
principle to the concept of certification authority being given to the 
States, they made it clear that their support was contingent on the 
resolution of these concerns. Another comment expressed confidence that 
States could manage certification responsibilities efficiently and 
effectively.
    The agency agrees that the basic intent of MQSA is to ensure that 
the performance of mammography meets uniform minimum national standards 
of quality. FDA believes that the proposed regulations and the 
associated agency oversight actions provide adequate assurance that 
this intent will continue to be met after certification authority is 
given to individual States. In response to the first comment, however, 
the agency has made changes in the regulations to further strengthen 
this assurance.
    FDA made five changes in Secs. 900.21 and 900.22 to make it easier 
for FDA to determine if an applicant's standards of quality meet or 
exceed the uniform minimum national standards. The first, in 
Sec. 900.21(a), replaced the words ``substantially equivalent to'' with 
``at least as stringent as.'' The second, in Sec. 900.21(b)(3)(ii), 
replaced the words ``their equivalence to'' with ``that they are at 
least as stringent as.'' The third, in Sec. 900.21(c), replaced the 
words ``substantially equivalent'' with ``at least as stringent as.'' A 
similar change in Sec. 900.22(b) replaced the words ``equivalent to'' 
with ``at least as stringent as.'' These four changes were intended to 
clarify the nature of the information that the agency is seeking. The 
fifth change adds a new Sec. 900.21(b)(3)(iii)(O) to ensure that the 
SAC State will make it clear to FDA and to the affected facility when 
an action taken against a facility is based upon more stringent State 
standards. This addition was made to clarify that a State may only 
impose the more stringent requirements under State law.
    In addition, two changes were made to emphasize that after approval 
as a certification agency, a State must continue to ensure that the 
intent of MQSA is met. The words ``regulations or'' have been inserted 
in Sec. 900.23 to emphasize that the annual evaluation of certification 
agencies will include a review of the certification agency's 
regulations to ensure that they remain adequate for MQSA purposes. 
Also, the words ``has failed to achieve the MQSA goals of quality 
mammography and access'' were added to Sec. 900.24(a) to make it clear 
that FDA can withdraw approval of a certification agency should a SAC 
State fail to achieve the MQSA goals.
    FDA will cover the oversight actions, which FDA believes help 
ensure that uniform national minimum standards of quality will be met, 
in more detail with the discussion of the comments on specific 
provisions of the regulations. In addition, comment 14 of this document 
discusses a change made in Sec. 900.24(b) in order to minimize a 
potential burden on facilities.
    (Comment 2) One person noted that his present understanding of 
FDA's intent regarding data transmission between accreditation bodies 
and State certifying agencies is that the accreditation bodies would 
provide data to FDA and FDA would then pass it on to the State 
certifying agencies. The comment approved of this planned flow and 
urged that it be specified in the regulations.
    The comment does correctly describe FDA's intent with respect to 
electronic transmission of data. The agency believes that this pathway 
is much more efficient and cost effective than if multiple pathways had 
to be developed between accreditation bodies and certifying States. It 
is also the most effective way of maintaining the national database 
required for MQSA activities. However, FDA does not believe that it is 
necessary to specify this intent in the regulations and so rejects this 
comment.
    (Comment 3) One comment noted that there are very minimal 
differences between the content of the proposed regulations for State 
certification of mammography facilities and the existing requirements 
met by accreditation bodies.
    This similarity was intentional on the agency's part. FDA 
recognized that the information needed to determine if FDA could 
approve a State as a certification agency was similar in many respects 
to that required to determine if FDA could approve an accreditation 
body. Furthermore, the responsibilities of, the procedures to be 
followed by, and the resources needed by SAC States and accreditation 
bodies show many similarities. It seems most efficient for both FDA and 
the States, especially States that might wish to be both an 
accreditation body and a certification agency, to pattern the 
requirements for certification agencies on those for accreditation 
bodies. In addition, patterning the proposed SAC requirements on those 
for accreditation bodies permitted the SAC effort to benefit from the 
experience gained from the agency's work with the accreditation bodies. 
The accreditation body requirements have been able to ensure uniform 
accreditation standards, even though five accreditation bodies are 
presently involved. Similar certification requirements will help 
achieve continued assurance that all mammography facilities will meet a 
uniform minimum national standard of quality with multiple 
certification agencies.
    (Comment 4) One comment noted that State radiation control agencies 
have requested implementation of MQSA (42 U.S.C. 263b(q)) which 
provides for certification authority to be given to the States, almost 
since the implementation of MQSA in 1994. It went on to say, ``We feel 
it is important to note the fact that the proposed regulations are 
neither

[[Page 5450]]

complex nor sufficiently voluminous to require more than five years to 
achieve publication in the Federal Register.''
    FDA has been aware since the early days of the program that some 
States have been very interested in seeing 42 U.S.C. 263b(q) 
implemented. At a Dallas, TX meeting convened by FDA and the CRCPD in 
January 1994 to obtain comments from the State radiation control 
programs on the agency's plans to implement MQSA, representatives of 
some States urged FDA to make the implementation of 42 U.S.C. 263b(q) 
its highest priority.
    In establishing its priorities for the implementation of MQSA, the 
agency had to first focus on those actions required by law. These 
actions included: (1) Developing quality standards, (2) approving 
accreditation bodies, (3) certifying facilities, and (4) establishing 
an inspection program. Other permitted actions, including the transfer 
of certification authority to interested States, had to be given a 
lower priority in order to accomplish these mandates. Had FDA focused 
its attention on implementing 42 U.S.C. 263b(q) rather than on its 
mandates, access to mammography could have been seriously compromised.
    After October 1, 1994, FDA had other legislative mandates to meet 
that would have a more immediate impact in ensuring quality mammography 
and were viewed by Congress to be of greater urgency than implementing 
42 U.S.C. 263b(q). One of the mandates included the establishment of 
the annual inspection program, which involved developing criteria and 
training and equipping a corps of 250 inspectors. Also, in granting FDA 
special authority for interim regulations, Congress sent a clear 
message as to the importance it attached to quickly replacing the 
interim regulations with more comprehensive final regulations. Again, 
FDA focused its resources toward meeting these mandated requirements. 
In August 1998, with the final regulations published, FDA increased its 
efforts to implement 42 U.S.C. 263b(q) by establishing a SAC 
Demonstration Project based upon valuable information provided by a SAC 
working group of State, Federal, and professional personnel assembled 
in June 1996.
    The agency believes that its order of priorities was also 
advantageous for future SAC certification agencies. If the agency had 
first implemented 42 U.S.C. 263b(q) and then developed its inspection 
program and the final regulations, State certification agencies would 
have had to constantly adjust their programs as the FDA efforts 
unfolded. The agency also believes that the information gained from 
preliminary activities in the Demonstration Project will, in the long 
run, save both time and effort for the SAC States and the facilities 
under the regulatory program. In addition, FDA believes that its 
implementation priorities will help ensure that the SAC program will be 
immediately effective in maintaining uniform minimum national standards 
of quality for mammography.

B. Comments on Application for Approval as a Certification Agency 
(Sec. 900.21)

    Section 900.21 defines State eligibility for becoming a 
certification agency, outlines the required content of the application, 
and provides details on the general framework for the processing of the 
application. Some of the comments received on this section were related 
to the paperwork burden and FDA will discuss them under section VIII of 
this document. FDA's response to the other comments follows.
    (Comment 5) One respondent suggested that Sec. 900.21(a) be 
reworded to indicate that States must have the authority to enter into 
an agreement with FDA, as this implied more than simply saying that the 
State is capable of entering into an agreement. A second comment stated 
that FDA should clarify this section.
    FDA agrees that clarification is needed. However, the agency 
believes that the rewording suggested by the first respondent is too 
limited in that it focuses only on the State having the authority to 
enter into a legal agreement. The phrase ``capable of meeting the 
requirements'' was also intended to mean that the State must have the 
resources needed to carry out the agreement. Therefore, FDA has revised 
this provision to read: ``(a) Eligibility. State agencies may apply for 
approval as a certification agency if they have standards at least as 
stringent as those of Sec. 900.12 of subpart B of this part, qualified 
personnel, adequate resources to carry out the States as Certifiers' 
responsibilities, and the authority to enter into a legal agreement 
with FDA to accept these responsibilities.''
    (Comment 6) One comment noted that Sec. 900.21(b)(3)(iii)(F) 
requires an applicant to submit to FDA information on the 
qualifications of the applicant's professional and supervisory staff 
but does not specify the minimum criteria for these qualifications. The 
author asked how applicants would know if members of their staff were 
qualified.
    FDA agrees that an interested State might need more information on 
qualification criteria. However, the agency believes it would be 
preferable to provide this information through guidance and direct 
consultation instead of codifying a set of minimum criteria in the 
regulations. Position categories differ greatly from State to State in 
their requirements and descriptions. Also, individuals with a variety 
of backgrounds can perform some of the tasks required of a 
certification agency. In light of these differences, FDA believes that 
it needs flexibility in handling the issue of personnel qualifications 
that would not be available if minimum criteria were established by 
regulation.
    To improve clarity, FDA also made minor editorial changes in some 
of the provisions of Sec. 900.21.

C. Comments on Standards for Certification Agencies (Sec. 900.22)

    Section 900.22 outlines the responsibilities of the SAC States and 
requires them to implement FDA-approved measures to ensure that there 
will be no conflict of interest or facility bias in carrying out these 
responsibilities.
    (Comment 7) Two comments urged FDA to delete or modify 
Sec. 900.22(c) so that the certifying agency would not have the 
responsibility of ensuring that facilities are in compliance with the 
quality standards. One author went further and made the conflicting 
statement that ``Given that Section 900.23 will ensure that a 
certifying State meets its responsibilities, subsection (c) is 
unnecessary.'' It was not explained how Sec. 900.23 would ensure that 
the SAC State would carry out its compliance responsibilities if the 
author's previous suggestion were followed that such responsibilities 
should not be given.
    FDA was surprised to receive these comments from representatives of 
State radiation control programs. Compliance with the quality standards 
by the facilities is the key factor in achieving the MQSA goal of 
quality mammography nationwide. Ensuring that the facilities they 
certify are in compliance with the quality standards is by far the most 
significant of the activities that the agency is proposing to give to 
the SAC States. If FDA does not give this authority, it would have to 
remove not only Sec. 900.22(c) but also Sec. 900.22(d), (e), (f), and 
(g), which are activities to ensure compliance with the quality 
standards. This would limit the new responsibilities given to the SAC 
States to the point that there would be little incentive for States to 
join the program. From the information supplied by the working group 
and informal contacts with State personnel, FDA

[[Page 5451]]

believes that most of the States interested in becoming certification 
agencies want the responsibility for ensuring that the facilities they 
certify are in compliance with the quality standards. The agency also 
notes that 42 U.S.C. 263b(q) specifically references the compliance 
activities as one of the responsibilities that may be given to States. 
FDA believes that compliance activities by SAC States are appropriate 
and therefore did not accept these comments.
    (Comment 8) One comment expressed concern about how appeals of any 
adverse accreditation decisions based on failure of clinical images 
would be handled by certifying States. The authors recommended that 
Sec. 900.22(e) should in some way ensure that such appeals do not 
result in less qualified personnel in a SAC State overruling the 
``highly qualified'' ACR personnel who made the original decision.
    FDA agrees that interpreting physicians participating in the 
appeals process or in decisions about additional mammography review or 
patient notification should be adequately qualified for those duties. 
However, FDA believes that it is more appropriate for the agency to 
ensure that the SAC State has adequately qualified review interpreting 
physicians through FDA's application review and oversight functions 
rather than through regulations.
    (Comment 9) One comment expressed concern about the criteria being 
used to initiate additional mammography review (AMR). The authors 
stated that they believed that requests for AMR were increasing. They 
recommend that, as stated in the current MQSA regulations, such reviews 
should be limited to cases where ``mammography quality at a facility 
has been compromised and may present a serious risk to human health * * 
*.''
    FDA agrees that the above statement is the criterion in 
Sec. 900.12(j) for the initiation of an AMR. The agency believes that, 
in accordance with the goal of ensuring uniform minimum standards for 
quality mammography nationwide, this criterion should continue to apply 
within the SAC States as well as in the non-SAC States. To ensure that 
there is no misunderstanding on this point, FDA is modifying 
Sec. 900.22(f) to the following:
    There shall be a process for the certification agency to request 
additional mammography review from accreditation bodies for issues 
related to mammography image quality and clinical practice. The 
certification agency should request additional mammography review 
only when it believes that mammography quality at a facility has 
been compromised and may present a serious risk to human health.
    (Comment 10) One comment stated that Sec. 900.22(g) should require 
patient notification to take place whenever an uncertified facility is 
found to be operating, regardless of the clinical image review 
determination of pass or fail. A second comment went further in arguing 
that if a facility has performed mammography without certification, 
``additional clinical image review is irrelevant.'' The author of that 
comment urged that the ``underlying assumption should be that if a 
facility has not complied with the fundamental legal requirement of 
obtaining a certificate prior to performing mammography, there is no 
assurance that the facility has met any of the applicable standards for 
certification.'' The author went on to say ``if standards were not met 
in obtaining images, additional image review is not going to rectify 
the problem. Delaying notification of affected patients until 
additional clinical image review is conducted unnecessarily puts those 
patients at risk.''
    FDA believes that the ``underlying assumption'' of the author of 
the second comment is not necessarily correct, especially when a 
facility has been previously certified, passed its inspections, and the 
time of operation without a certificate was short. On the other hand, 
the agency understands the concern about possible risk to patient 
health if notification is delayed in cases where the facility not only 
operated without a certificate, but also failed to meet other quality 
standards, thus resulting in poor quality mammography. This concern, 
however, must be balanced against the unnecessary stress and alarm that 
could be caused if patients are notified of the lack of certification 
when an AMR would have shown that the quality of mammography was 
acceptable. Furthermore, if this alarm caused patients to undergo 
unnecessary repeat examinations, additional radiation exposure and 
expense would result.
    Because of the need to balance these two concerns, FDA and the 
State certification agencies need to have the flexibility to deal with 
such situations on a case-by-case basis. For this reason, the agency 
has rejected the suggestion for mandatory patient notification in every 
case where a facility has operated without a certificate.
    (Comment 11) One comment suggested a change in Sec. 900.22(i), 
which requires certification agencies to obtain FDA authorization ``for 
any changes it proposes to make in any standards that FDA has 
previously accepted under Sec. 900.21 of this section.'' The comment 
urged that the words ``obtain FDA authorization'' be changed to 
``coordinate with FDA to ensure comparability with MQSA requirements.'' 
The reason given was that they did not feel that FDA could 
``authorize'' a State to make changes in its regulations. A second 
comment expressed a similar concern. The author noted that it would be 
prudent for a certification agency to discuss contemplated changes in 
State standards with FDA. FDA then had the right to make it known to 
the certification agency if it found the changes inconsistent with 
MQSA. The author also acknowledged that if the certification agency did 
not cooperate in removing the inconsistency, ``FDA can take appropriate 
action.'' The comment concluded with the statement that it would be 
``inappropriate and unacceptable'' for FDA to require formal 
authorization for changes a State agency may want to make in its 
standards.
    FDA notes that 42 U.S.C. 263b(q) gives the agency the authority to 
``authorize'' a State to ``implement the standards'' established by 
FDA. The agency believes that to ensure that these minimum standards 
are implemented uniformly nationwide, in both SAC States and non-SAC 
States, the SAC States must have standards in their regulations that 
are at least as stringent as the MQSA quality standards. This 
stringency level must exist at the time the State receives 
certification authority. Therefore, as part of its application, 
prospective certification agencies must submit their facility 
mammography standards for review. The State standards must also remain 
as stringent as the MQSA quality standards for as long as the State is 
a certification agency. However, this cannot be guaranteed if the State 
is free to change its standards after only ``discussion'' or 
``consultation'' with FDA. Therefore, the agency believes that it is 
not only appropriate, but also required under 42 U.S.C.263b(q), that 
FDA authorize changes in State standards before they are put into use 
by the State in its activities as a certification agency.
    At the same time, the agency recognizes that the term 
``authorize,'' used in the statute and repeated in the regulations, may 
be contributing to the concerns of those making the comments because 
they may be interpreting it as meaning more than is intended. FDA does 
not intend to say that a State needs ``authorization'' from the agency 
to make changes in its regulations. The agency does intend to say, for 
the reason just discussed, that a SAC State needs FDA approval of its 
changed regulations

[[Page 5452]]

before it can use them in the exercise of its SAC authority. To clarify 
this point, FDA has added a definition of ``authorization'' as a new 
Sec. 900.2(bbb).
    As further clarification of what was intended with this 
requirement, the words ``before requiring facilities to comply with the 
changes'' have been added at the end of Sec. 900.22(i). This further 
clarification was prompted by the second comment, which seems to 
suggest that FDA take action to correct inappropriate State regulation 
changes, which would affect a State's SAC role, after they are put into 
effect, instead of requiring agency authorization before they are put 
into effect. FDA does recognize that, as suggested by the comment, 
there are actions available to it, including withdraw the certification 
agency's authority to certify, if ``discussion'' and ``coordination'' 
are not effective in maintaining consistency between the State's 
standards and the MQSA standards. However, to take such action after 
the State standards are put into use would be very disruptive to the 
facilities certified within the State. In most States, it would require 
some time for the State regulations to be amended to remove the 
inconsistencies so that the State could become a SAC State again. FDA 
believes it would be preferable to prevent such problems from occurring 
rather than to correct them afterward. The most effective way of doing 
this is to require States to obtain FDA ``authorization,'' to use the 
terminology in MQSA, for changes in State standards before using them 
in their certification activities.
    (Comment 12) Two comments urged that inspector training be 
delegated to the SAC States as a cost saving measure. Although these 
comments are outside the scope of the regulations, FDA has provided the 
following answer. As previously stated, the goal of the MQSA program is 
to ensure that all mammography facilities nationwide meet uniform 
minimum quality standards. A key factor in achieving this assurance is 
the uniform application of the MQSA quality standards during 
inspections. To achieve this uniform application, it is crucial that 
all inspectors have a uniform training experience. FDA doubts that 
uniformity of training can be achieved if multiple independent training 
centers are used in the place of a single center.
    The agency also questions whether States can provide training of 
the same quality and quantity as the FDA training at less cost. FDA 
provides 6 weeks of specialized training for prospective inspectors. By 
the completion of their training, the inspectors have benefitted from 
contact with over a dozen instructors and received about the same 
number of hours of instruction as given in a typical year of graduate 
school. In addition, they are required to complete mentored inspections 
in the field before FDA certifies them as MQSA inspectors. Because the 
States are already providing the field training, there would be no 
increase or decrease in cost for that component if the SAC States were 
given full responsibility for training their inspectors. Any 
possibility of cost savings by the States would have to come in 
providing the basic classroom training.
    Now that FDA has completed the initial buildup of approximately 250 
inspectors, a single series of classes per year, graduating 
approximately 20 inspectors, is generally sufficient for replacement 
purposes. Individual States rarely find it necessary to have more than 
one inspector trained a year. It is unlikely that State training 
programs would be able to provide comparable training to that described 
above at a per inspector cost less than that of FDA, because such 
programs would lose the benefit of economy of scale.
    Neither of the comments advocating training of inspectors by States 
provided any details on the nature of the training they envisioned. 
Only one provided a cost figure but it contained no details on how it 
was estimated. The two comments failed to provide a basis for 
concluding either that State training of inspectors would be less 
costly than the FDA training or that training at multiple independent 
centers can be conducted in such a way as to ensure uniform training of 
inspectors. Therefore, FDA concludes that, for the present, the agency 
should retain responsibility for training as well as certifying 
inspectors. However, FDA will re-evaluate this position after the SAC 
program expands and additional experience is gained.
    (Comment 13) One comment noted that in the list of the authorities 
to be delegated to the States in the preamble to the proposed 
regulations, the authority for certification is included but a short 
while later it is stated that ``FDA retains authority to suspend or 
revoke the certificate of facilities within an approved State.'' The 
authors believed that this was in conflict with the law and noted that 
no reason was given for this decision. The comment asked ``What if a 
State has been given that authority by State law?''
    The MQSA statute has provisions for both States and the agency to 
suspend or revoke certificates in SAC States. States may be approved to 
carry out the certification program requirements under 42 U.S.C. 
263b(q)(1)(A), which includes the suspension and revocation of 
certificates. As a condition for becoming a State certification agency, 
an agency must have authority under State statute to accept and carry 
out the SAC responsibilities. However, 42 U.S.C. 263b(q)(3)(B) 
specifically states that, in a State given certification authority, FDA 
may take action under 42 U.S.C. 263b(i), which is the part of 42 U.S.C. 
263b giving authority to suspend and revoke certificates. Consequently, 
there is no conflict with the law.
    FDA has written and spoken about dual authority in many public 
forums. The agency has always asserted that it does not intend to 
exercise its certification authority in SAC States except in rare 
circumstances. Thus far, the agency has not used this authority during 
the SAC Demonstration Project. FDA would also like to make it clear 
that should it suspend or revoke a certificate in a SAC State on its 
own authority, the implications of that action are limited to the 
facility losing its certificate. FDA's action should not be construed 
as meaning that it is ``taking back'' the general authority of the SAC 
State to suspend or revoke certificates of facilities within its 
borders. Such a general resumption of authority would occur only if the 
agency withdraws its approval of the SAC State as a certification 
agency.
    To improve clarity, FDA also made minor editorial changes in some 
of the provisions of Sec. 900.22.

D. Comments on Evaluation (Sec. 900.23)

    Section 900.23 of the proposed regulations provides for annual 
evaluation of the certification agencies by FDA and describes some of 
the details of the evaluation.
    (Comment 14) One comment warned that, to ensure consistency, 
continuity, and the quality of mammography, FDA would have to impose an 
extensive and active review of the State certification authorities. The 
authors believed that the extent of this evaluation was not made clear 
in the regulations and asked questions about: (1) Whether FDA would 
conduct followup inspections to validate the certification agency 
inspections, (2) how frequent the followup inspections would be, and 
(3) how discrepancies between the State inspections and followup 
inspections would be handled. The comment also included an expression 
of concern about the possibility that the cost of an adequate 
evaluation program might be unreasonable.
    FDA notes that FDA auditors accompany State inspectors on selected 
inspections to observe and, if necessary, correct their performance. In 
this way,

[[Page 5453]]

the agency increases the probability that the quality standards are 
enforced correctly and uniformly throughout the country. Currently one 
audit inspection is conducted for each State inspector annually. FDA 
may do additional reviews of specific inspections if there are 
questions about an inspector's performance. These audit inspections 
have been conducted in the SAC States as well as the non-SAC States. 
Because such inspections are already being performed, there will be no 
new costs for their performance in SAC States.
    The agency also expects to evaluate the performance of the 
certification agencies through mechanisms similar to those currently 
used for accreditation bodies. These include reviews of annual reports 
and other documents provided by the certification agencies. An FDA 
evaluation team will conduct periodic site visits to the certification 
agency. At present, quarterly performance reports are required from the 
SAC States participating in the Demonstration Project. If FDA 
determines that performance of the certification agency is 
unsatisfactory, Sec. 900.24 provides the agency with the authority to 
take appropriate action.
    (Comment 15) One comment urged that ``The mentioned performance 
indicators should be delineated in the rule or developed as guidance 
and available for review and comment and not developed at a further 
date. Guidance on complying with these indicators could be developed at 
a later date, but the indicators themselves should be contained within 
the rule.''
    FDA notes that performance indicators were developed for use in the 
SAC Demonstration Project with the aid of review and comments from the 
SAC working group. As FDA gained experience from that project, the 
indicators were modified to make them more appropriate. Further 
modification may be necessary as the program grows. Consequently, FDA 
believes that it is premature to codify the performance indicators in 
regulation. Greater flexibility is available through the guidance 
process to make adjustments to the indicators more rapidly, should that 
be necessary.
    To improve clarity, FDA also made minor editorial changes in some 
of the provisions of Sec. 900.23.

E. Comments on Withdrawal of Approval (Sec. 900.24)

    Section 900.24 makes a range of actions available to FDA for use 
when a certification agency is not in substantial compliance with the 
regulations.
    The words ``after providing notice and opportunity for corrective 
action'' have been added in the first sentence of Sec. 900.24(a) in 
order to incorporate a requirement from the statute itself. This 
requirement was mistakenly left out of the proposed regulation.
    (Comment 16) One comment supported implementation of the SAC 
program providing that it can be carried out ``without incurring an 
undue financial, compliance, or legal burden on the mammography 
facilities or public.'' Under Sec. 900.24(a), FDA may withdraw approval 
of a certification agency if it fails to correct major deficiencies. 
Under Sec. 900.24(b), FDA may place a certification agency on probation 
while it corrects minor deficiencies in the performance of its 
responsibilities. If a certification agency fails to correct these 
deficiencies while under probation, FDA may withdraw its approval of 
the agency. If FDA withdraws approval of a certification agency under 
either of these circumstances, the facilities certified by the agency 
would again have to become certified by FDA. There would be some burden 
on the facilities in making such transfers. FDA will develop 
administrative procedures for the transfer to minimize the burden to 
the extent possible. In addition, FDA believes that giving the 
facilities advanced notice that such a transfer may be necessary, so 
that the facility may be prepared for the possibility will further 
minimize the burden. Therefore, a sentence has been added to 
Sec. 900.24(a) requiring a certification agency that has been ordered 
to carry out corrective actions for major deficiencies to notify all 
facilities certified or seeking certification by it of this order. 
Similarly, a new paragraph (b)(1) has been added to Sec. 900.24 
requiring a certification agency to notify all facilities certified or 
seeking certification by it during the probation period if the agency 
is placed on probation.
    (Comment 17) The introduction to this section states that if ``a 
certification agency is not in substantial compliance with this 
subpart, FDA may initiate the following action * * *.'' One comment 
urged that the agency define ``substantial compliance'' or delete the 
word ``substantial.''
    FDA believes that to make either of these changes would remove the 
flexibility that it needs to respond appropriately to a wide variety of 
conditions. Deleting the word ``substantial'' would mean that any 
deviation from the requirements, no matter how minor, would require 
action against the certification agency. On the other hand, because it 
would be impossible to foresee all possible situations in which action 
might have to be considered, any definition of ``substantial 
compliance'' would inevitably be incomplete. In order to retain the 
flexibility to evaluate each individual situation and to arrive at the 
course of action most appropriate for it, FDA rejects this comment.

F. Suggestions for Additions to the Regulations

    (Comment 18) One comment urged FDA to address the use of ``interim 
notices'' in the regulations instead of in guidance, as it is at 
present. The authors noted that their State planned on promulgating 
regulations to include criteria and processes for issuing interim 
notices and stated the opinion that most State administrative procedure 
statutes would require similar regulations for their certification 
agencies. They urged FDA to include the interim notice process in its 
own rules to serve as a model for the State rules. A second comment 
suggested clarifying the term ``interim notice'' by terming it 
``interim notice of certification.'' A third comment urged FDA to 
differentiate between the issuance of interim notices to new facilities 
under a provisional status and existing facilities that receive interim 
notices due to delays or failure in the accreditation process.
    Interim notices are issued by FDA or a certification agency to a 
facility in a variety of situations, including accreditation delays, 
nonreceipt of a certificate, and to bridge the gap of time between 
certificate issuance and facility receipt of a certificate. The notice 
permits a facility to perform mammography while waiting for the 
certificate to arrive by mail. FDA devised this process as a way to 
handle the immense task of completing the accreditation and 
certification of thousands of facilities in a relatively short period 
of time during the early days of the MQSA program. FDA retained the 
process after those early years as the accreditation bodies continued 
to make adjustments to their fluctuating workload. Situations sometimes 
arose where without such a mechanism, a facility would have to cease 
operating for a period of time, even though its staff had carried out 
their responsibilities properly and promptly.
    FDA notes that it is reconsidering the future use of interim 
notices separately from the development of the SAC regulations. 
Therefore, it is premature to respond to this issue. However, in its 
examination of the interim notice issue,

[[Page 5454]]

FDA will consider the specific comments made.
    The agency also notes that interim notices are not presently 
mentioned in the SAC regulations. The interim notice process could not 
be added to the regulations without giving the public the opportunity 
to comment. If such regulations were incorporated into the SAC 
regulations, they would have to be reproposed. Thus, the publication of 
the final SAC regulations would be delayed for at least 6 months to 1 
year, which many States would find unacceptable. If FDA determines that 
there is a need to add regulations on interim notices, the agency will 
publish a proposal and give the public an opportunity to comment. With 
respect to the plans of one State to issue regulations of its own with 
respect to interim notices, the agency notes that the mammography 
regulations of a State acting as a certification agency must continue 
to be at least as stringent than those of FDA. If a State proceeds with 
its own interim notice regulations, it may have to amend those 
regulations after FDA makes its decision on the future of interim 
notices or may find that its regulations do not satisfy MQSA's SAC 
requirements because they are less stringent than the MQSA regulations. 
With these considerations in mind, States interested in such 
regulations may wish to wait until FDA makes a final decision on this 
issue.

IV. Environmental Impact

    The agency has determined under 21 CFR 25.30(g) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

V. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612 (as 
amended by subtitle D of the Small Business Regulatory Fairness Act of 
1996 (Public Law 104-121)), and the Unfunded Mandates Reform Act of 
1995 (Public Law 104-4). Executive Order 12866 directs agencies to 
assess all costs and benefits of available regulatory alternatives and, 
when regulation is necessary, to select regulatory approaches that 
maximize net benefits (including potential economic, environmental, 
public health and safety, and other advantages; distributive impacts; 
and equity). FDA published an impact analysis in association with the 
proposed regulations. After a thorough analysis of the comments 
received on the impact analysis as described below, FDA concluded that 
none of the comments made a convincing case for changing either the 
methods used in the cost analysis or the conclusions drawn from it. 
Therefore, FDA has concluded that this final rule is consistent with 
the regulatory philosophy and principles identified in the Executive 
order. In addition, the final rule is not a significant regulatory 
action as defined by the Executive order and so is not subject to 
review under the Executive order. A full discussion of the comments FDA 
received on the analysis follows.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. The final rule will have no significant economic 
impact on a substantial number of small entities because it applies 
only to States wishing to become certification agencies. However, as 
part of its Regulatory Impact Study, FDA did analyze the potential for 
changes in costs to facilities. As will be discussed later in the worst 
case revealed by the analysis, some mammography facilities may 
experience a small increase in cost. However, because States are not 
likely to enter the program unless their entry will be of benefit to 
the facilities within their borders, a cost savings to the public as a 
whole and to mammography facilities is more likely to occur. Therefore, 
the agency certifies that the final rule will not have a significant
economic impact on a substantial number of small entities. Therefore, 
under the Regulatory Flexibility Act, no further analysis is required.

A. Scenarios Used

    FDA realized that the cost impact of these regulations would be 
heavily dependent upon the number and characteristics of the States 
that choose to participate in the SAC program. However, because 
participation is entirely voluntary on the part of the States, FDA 
could not determine in advance which States would decide to become SAC 
States. The first assumptions made, therefore, were related to which 
States might become SAC States. FDA used three scenarios to establish 
the possible range of the impact of these regulations.
    Scenario 1--FDA assumed only the States of Iowa and Illinois, the 
current participants in the SAC Demonstration Project, would choose to 
participate in the program.
    Scenario 2--FDA assumed that six additional States, which have in 
the past indicated significant interest in becoming SAC States, would 
join Iowa and Illinois in the SAC program.
    Scenario 3--FDA assumed that seven additional States would join the 
eight States included in the scenario 2 analysis. These additional 
States have indicated some interest in becoming SAC States when the 
program is fully implemented.
    The selection of the States for these scenarios does not indicate 
either a commitment by the States to participate or a commitment by FDA 
to accept their participation in a future SAC program. Both the six 
States added in scenario 2 and the seven added in scenario 3 have a 
wide geographic distribution and the number of mammography facilities 
within their borders ranges from relatively large to relatively small. 
Although the basis of selection was FDA's perception of States' 
interest, the resulting groups are representative of the country as a 
whole.

B. Pre-SAC and Post-SAC Funding of MQSA Activities

    Funding to support the MQSA activities pre-SAC comes from two 
sources: Inspection fees and federally appropriated funds. By statute, 
FDA must pay for all inspection costs by collecting fees from the 
mammography facilities. The present inspection fee is $1,549 per 
facility plus an additional $204 per mammography unit for each unit 
beyond the first at the facility. Appropriated funds support all 
activities other than those that are covered by this fee. In addition, 
an amount equal to the inspection fee for each governmental entity is 
allotted from appropriated funds to support the inspection program for 
those facilities. These sources of funding will continue to be relied 
upon for support of MQSA activities in States that choose notto enter 
the SAC program.
    If a State becomes a SAC State, the nongovernmental facilities 
within that State will pay an inspection support fee to FDA to 
reimburse the agency, as required by statute, for the inspection 
support services that the agency will continue to provide. This 
inspection support fee has been initially set at $509 per facility, 
regardless of the number of mammography units in the facility. As with 
the inspection fees in non-SAC States, this fee will be collected in a 
given year only from those facilities in SAC States that were actually 
inspected during that year. The same amount will also be provided from 
appropriated funds for each governmental entity inspection within the 
SAC States.
    The SAC State will determine how the responsibilities that it has 
assumed will be funded. For example, the

[[Page 5455]]

funding could come from State appropriations, a certification fee 
charged by a SAC State, registration fees, or a combination of sources.

C. Phases of the Analysis

    FDA carried out the cost impact analysis in several phases. In 
phase 1, the costs or savings from the SAC program to the public as a 
whole were estimated by comparing FDA's pre-SAC costs (for performing 
various functions that would be given to the States) with the post-SAC 
costs for FDA and SAC States in each of the three scenarios. In this 
initial analysis, the agency assumed that the inspection fee would 
remain unchanged from the present value. The results of this phase are 
shown in tables 1 through 3 of this document.
    The second phase of the analysis looked at the impact that would 
result on the costs or savings to the public as a whole if inspection 
fees had to be changed. As States enter the SAC program, their 
facilities will be paying FDA the lower inspection support fee instead 
of the inspection fee. The funds available for the FDA inspection 
program thus will decrease as more States become SAC States. On the 
other hand, the cost of the FDA inspection program will also decrease 
because it will no longer include the cost of contracting with the 
States for inspecting facilities in the SAC States. The relative 
amounts of the decreases in funds available and inspection costs will 
be highly dependent upon which States enter the SAC program. If a State 
with a low inspection cost per facility becomes a SAC State, the 
decrease of funds available to FDA will be more than the decrease in 
program costs. As a result, the inspection fee in the non-SAC States 
will have to increase in order to provide sufficient funds to FDA to 
fulfill its MQSA inspection responsibilities. If a State with a high 
inspection cost per facility enters the SAC program, the reverse will 
be true. Table 4 of this document shows the estimated change in the 
funds needed from inspection fees in each of the three scenarios, and 
the impact this would have on the savings or cost to the public as a 
whole.
    In the third phase of the analysis, attention turned from the 
economic impact of the SAC regulations on the public as a whole to the 
impact on that portion of the public represented by small entities, as 
required by the Regulatory Flexibility Act. The agency considered all 
of the approximately 10,000 mammography facilities in the country to be 
small entities for the purposes of the analysis. In the case of 
facilities in the non-SAC States, this impact would manifest itself as 
an increase or decrease in the inspection fee, depending upon whether 
the second phase of the analysis showed that more or less money was 
needed to support the FDA inspection program.
    In the case of facilities in the SAC States, the analysis first 
involved determining the difference between the savings to facilities 
from no longer having to pay the FDA MQSA inspection fee to the costs 
to the facilities for the inspection support fee and the State costs. 
The difference was then divided by the number of SAC State facilities. 
Table 5 of this document shows the savings or costs to the small 
facilities in the non-SAC and SAC States under each of the three 
scenarios.
    The third phase of the analysis estimated the average impact on the 
SAC State facilities. The fourth phase showed that depending upon the 
State in which it was located, the actual impact upon an individual 
facility could vary widely. The amount of this impact was again highly 
dependent upon the cost of inspections within each State. The range of 
the impact was determined by comparing the situations for the lowest 
and highest inspection cost States among the 15 States included in 
scenario 3.
    The fifth phase of the analysis recognized the fact that although 
all mammography facilities are assumed to be small entities, they 
actually vary greatly in size. To further evaluate the impact on the 
smallest of the mammography facilities, the increase or decrease in per 
facility costs under the SAC program were compared to the facility 
revenues derived from mammography for a low volume mammography 
facility. For this comparison, a model developed by the Eastern 
Research Group was used. This model estimated that the lowest volume 
mammography facility (performing less than 300 mammograms annually) 
would have approximately $24,000 in annual revenues from mammography.
    The projected reporting and recordkeeping for SAC States is 
discussed in detail in the Paperwork Reduction Act (the PRA) of 1995 
section. The rule imposes no new reporting and recordkeeping 
requirements on mammography facilities, and, thus, no additional 
professional skills are necessary.

D. Discussion of Results

    Tables 1 through 3 of this document give the results from the first 
phase of the analysis. These results support the initial statement that 
the potential net savings or cost to the public from the SAC program is 
heavily dependent upon the number and characteristics of the States 
that choose to become SAC States. All three of the scenarios show that 
there is the potential for savings to the public from the SAC program. 
However, the estimated amount of the savings is not proportional to 
either the number of States in the program or the number of facilities.

                       Table 1.--Cost to the Public of MQSA Functions in Non-SAC\1\ States
----------------------------------------------------------------------------------------------------------------
                                       Non-SAC States Facilities
             Scenario                 (Percent of National Total)                Non-SAC States Cost
----------------------------------------------------------------------------------------------------------------
Baseline                                         100                                  $16,067,499
1                                                 94.1                                $15,140,562
2                                                 73.8                                $11,841,663
3                                                 46.0                                 $7,394,421
----------------------------------------------------------------------------------------------------------------
\1\ SAC means States as Certifiers.


                         Table 2.--Cost to the Public of MQSA Functions in SAC\1\ States
----------------------------------------------------------------------------------------------------------------
       Scenario            Facilities (Percent of National Total)                  SAC States Cost
----------------------------------------------------------------------------------------------------------------
Baseline                                           0                                           $0
1                                                  5.9                                   $709,870
2                                                 26.2                                 $3,650,563

[[Page 5456]]

 
3                                                 54.0                                 $8,180,723
----------------------------------------------------------------------------------------------------------------
\1\ SAC means States as Certifiers.


                              Table 3.--Savings to the Public--First Phase Analysis
----------------------------------------------------------------------------------------------------------------
    Scenario       Non-SAC\1\ State Cost       SAC State Cost            Total Costs          Savings to Public
----------------------------------------------------------------------------------------------------------------
Baseline                 $16,067,499                    $0               $16,067,499                    $0
1                        $15,140,562              $709,870               $15,850,432              $217,067
2                        $11,481,663            $3,650,563               $15,492,226              $575,273
3                         $7,394,421            $8,180,723               $15,575,444              $492,055
----------------------------------------------------------------------------------------------------------------
\1\ SAC means States as Certifiers.

    Whether the SAC program will save (or cost) the public more money 
than the pre-SAC program depends upon whether SAC States can carry out 
their SAC functions more or less economically than these functions were 
carried out within their borders pre-SAC. The biggest component of the 
cost to the public pre-SAC is the inspection fee. This fee is a 
national average fee that is the same for all facilities no matter 
where they are located. On the other hand, the actual cost of 
performing the inspection varies widely from State to State. If a State 
whose inspection cost is significantly lower than the national average 
becomes a SAC State, there is an increased probability that the total 
cost per facility for inspections, the other State functions, and the 
inspection support fee will be less than the inspection fee that the 
facility paid pre-SAC. If so, there will be net savings to the public 
from that State becoming a SAC State. On the other hand, in States with 
high inspection costs, the combined cost per facility of the 
inspections, the other functions, and the inspection support fee may 
exceed the inspection fee, in which case there will be a net cost to 
the public arising from that State being in the SAC program.
    The bulk of the SAC facilities in scenario 1 are in a State with an 
inspection cost below the national average. It is not surprising then 
to find net savings in scenario 1. The inspection costs in the States 
added in scenario 2 range from slightly lower than to a little higher 
than the average. Again, it is not surprising to find that there is a 
net savings and, because the number of facilities in SAC States is 
greatly increased, it is also not surprising to find that the total net 
savings is significantly increased over scenario 1. On the other hand, 
in scenario 3, three of the States added have per facility inspection 
costs that are well above the national average. Thus, there is an 
increase in cost to the public arising from these States being in the 
program. The impact of their participation is magnified because these 
three States include over two thirds of the facilities added in 
scenario 3. As a result, there are lower net savings in scenario 3 than 
in scenario 2.
    The agency based the savings estimated in the first phase of the 
analysis upon the assumption that the inspection fee would not increase 
with the implementation of the SAC program. In the second phase of the 
analysis, however, FDA estimated additional amounts of $127,593, 
$563,710, and $605,208, in scenarios 1, 2, and 3, respectively, would 
have to be raised by increasing fees in order to provide sufficient 
funds for the FDA inspection program. Table 4 of this document shows 
the effect of applying these corrections to the previously estimated 
savings to the public as a whole. The savings to the public in scenario 
1 are reduced but still significant, those in scenario 2 virtually 
disappear, and in scenario 3 there would be an increase in cost.

                     Table 4.--Impact of Inspection Fee Increase on the Public as a Whole\1\
----------------------------------------------------------------------------------------------------------------
       Scenario                  Savings Before Fee Change                 Savings/(Cost) After Fee Change
----------------------------------------------------------------------------------------------------------------
1                                           $217,067                                      $89,474
2                                           $575,273                                      $11,563
3                                           $492,055                                   ($113,173)
----------------------------------------------------------------------------------------------------------------
\1\ SAC means States as Certifiers.

    Beginning with phase 3 of this analysis, the agency turned its 
attention from the economic impact on the public as a whole to the 
impact on that portion of the public represented by the mammography 
facilities. Table 5 of this document shows the estimated per facility 
savings or increased costs for facilities in both SAC and non-SAC 
States under the three scenarios.

              Table 5.--Estimated Per Facility Savings or (Costs) Resulting From the SAC\1\ Program
----------------------------------------------------------------------------------------------------------------
       Scenario            Non-SAC State Facility Savings (Cost)          SAC State Facility Savings (Cost)
----------------------------------------------------------------------------------------------------------------
1                                               ($16.52)                                     $150.45
2                                               ($93.16)                                        $.03
3                                              ($160.23)                                    ($128.67)
----------------------------------------------------------------------------------------------------------------
\1\ SAC means States as Certifiers.


[[Page 5457]]

    In all three scenarios, estimated costs increased for the non-SAC 
State facilities due to the need to increase the inspection fee to 
raise the necessary funds to support the FDA inspection program. 
However, even the largest of estimated increases was only about 10 
percent of the present fee.
    In the case of the facilities in the SAC States, there is an 
estimated per facility savings in scenario 1 but an estimated increased 
cost in scenario 3. The average cost per facility in scenario 2 is 
essentially unchanged. Again, this variation in impact from scenario to 
scenario is primarily due to the difference in inspection costs among 
the included States.
    As previously noted, however, the actual impact on an individual 
facility varies widely with the State. Phase 4 of the analysis 
illustrates the extremes of this variation among the States by 
comparing the situation in the State with the highest inspection 
contract cost per facility from among the 15 States to the situation in 
the State with the lowest inspection contract cost per facility. The 
facilities in the State with the lowest inspection cost would save, on 
the average, an estimated $200 per facility per year, which is a 
decrease of over 10 percent of the FDA inspection fee, if that State 
became a SAC State. Facilities in the State with the highest inspection 
cost, however, would have to pay an average of over $507 additional per 
year, an increase of one-third over the FDA inspection fee, if their 
State became a SAC State. Interestingly, both of the States joined the 
SAC program in scenario 3, where the second and third phases of the 
analysis showed that there was an overall increase in the cost to both 
the public as a whole and to the part of the public represented by the 
mammography facilities. Thus, even under scenarios where there is an 
overall cost increase, there may be savings in individual States.
    This great variation is a major reason why the nearly $700,000 cost 
to facilities in scenario 3 is a ``worst case'' situation that will 
probably never be reached. The States included in this analysis were 
States that had shown some level of interest in becoming a SAC State. 
The primary basis of this interest was a belief that by becoming a SAC 
State they could provide a service to the facilities and mammography 
patients within their borders. They expected to be able to provide an 
assurance of quality mammography at least equal to that under the 
national program but at a lower cost. If such a belief proves to be too 
optimistic in a particular State, due to high inspection costs or any 
other reason, it is unlikely that they will apply to become SAC 
States.The fifth and final phase of the analysis considers the 
potential impact of the SAC program on the smallest of the small entity 
mammography facilities (those with approximately $24,000 in annual 
revenues from mammography). Tables 6 and 7 of this document present the 
average facility costs in both non-SAC and SAC States as a percentage 
of low volume facility revenues in situations where there is an 
increased cost (all 3 scenarios for facilities in non-SAC States and 
scenario 3 for facilities in SAC States).

        Table 6.--Cost/Savings Per Facility in Non-SAC\1\ States
------------------------------------------------------------------------
                                                             Inspection
                                                            Fee Increase
  Scenario      Per Facility Increase in Inspection Fee    as Percentage
                                                            of Facility
                                                              Revenue
------------------------------------------------------------------------
1                                      $16.52              0.1%
2                                      $93.16              0.5%
3                                     $160.23              1.0%
------------------------------------------------------------------------
\1\ SAC means States as Certifiers.


                                Table 7.--Cost/Savings Per Facility in SAC States
----------------------------------------------------------------------------------------------------------------
                    Net (Cost)/Savings to     Average per Facility Net (Cost)/  Cost as a Percentage of Facility
    Scenario        SAC\1\ Small Entities                  Savings                         Revenues\2\
----------------------------------------------------------------------------------------------------------------
1                          $87,710                         $150.45                             NA
2                             $838                           $0.33                             NA
3                       ($691,595)                        ($128.69)                             1.0%
----------------------------------------------------------------------------------------------------------------
\1\ SAC means States as Certifiers.
\2\ Revenues for a facility performing less than 300 mammograms annually with revenues of approximately $24,000.

    Even the largest of the estimated increased costs represented less 
than 1 percent of the facility's revenue from mammography.

E. Unfunded Mandates

    The Unfunded Mandates Reform Act requires that agencies prepare an 
assessment of anticipated costs and benefits before proposing any rule 
that may result in an expenditure of $100 million or more in any one 
year by State, local, and tribal governments in the aggregate or by the 
private sector. Because participation in the SAC program is entirely 
voluntary on the part of the State and not mandated, and because the 
costs of those who choose to participate will be far less than $100 
million, FDA concluded that the proposed SAC regulation is consistent 
with the principles of the Unfunded Mandates Reform Act without the 
need for further analysis.

F. Alternative Regulatory Approaches

    In addition to the impact analyses discussed above, Executive Order 
12866 requires agencies to select regulatory approaches that maximize 
net benefits. To fulfill these obligations, FDA considered and rejected 
the following three alternatives:
1. Not Implementing Section 354(q) of the PHS Act
    Section 354(q) of the PHS Act states that FDA (with authority 
delegated from the Secretary of the Department of Health and Human 
Services) ``may'' authorize a State to carry out the certification and 
other functions listed above. FDA thus had the option of not 
implementing section 354(q) of the PHS Act and instead retaining the 
present centralized certification program. However, many States have 
indicated a strong interest in increasing their participation in the 
MQSA program to improve the quality of mammography. The analysis 
discussed above illustrates that such increased State participation

[[Page 5458]]

has the potential for economic savings to the public as a whole. In 
some States, there are also the potential economic savings for that 
portion of the public represented by the mammography facilities. In 
view of these factors, not implementing section 354(q) of the PHS Act 
could be justified only if its implementation would impede the basic 
objective of MQSA, the improvement of the quality of mammography. FDA 
has no evidence to indicate that this would be the case. On the 
contrary, increased State participation appears to have the potential 
of accelerating the improvement in the quality of mammography. Because 
of these considerations, FDA rejected this alternative.
2. Recognizing Existing State Certification Programs
    Several States already have programs in place for the certification 
of mammography facilities. FDA considered recognizing such existing and 
possible future programs in lieu of the approach taken in the proposed 
regulations, which is to require a State to establish a program as 
stringent as the national program in order to be authorized as a SAC. 
This alternative would have the advantage of lessening the effort the 
State would have to invest in meeting the requirements to be a SAC and 
would eliminate the need for facilities to have both MQSA and State 
certification. However, the existing State certifications vary in 
nature and extent and it would be expected that such a variation would 
increase if future State programs are created without the establishment 
of a consistent set of national standards for such programs. MQSA was 
designed to replace the existing patchwork of private and government 
efforts to improve the quality of mammography with a nationwide program 
that would ensure patients that the mammography they receive meets the 
same standards of quality, no matter where in the country they receive 
it. FDA concluded that this could not be guaranteed if existing and 
future State certification programs were simply recognized without the 
need to meet national standards.
3. Implementing Section 354(q) of the PHS Act Through the Issuance of 
More Detailed Regulations
    The approach taken in the proposed regulations is to seek to ensure 
that State certification programs that receive the delegated authority 
provide guarantees of quality mammography that are as stringent as 
those provided by FDA's national program but to allow the State 
programs some flexibility in the means used to achieve this goal. An 
alternative to this approach would be to impose more detailed 
requirements that would have to be met for a State to receive 
certification authority. FDA rejected this approach because it was 
believed that this would sacrifice the advantages to be gained by 
giving the State programs the flexibility to tailor their program to 
best fit the local conditions in the State.

G. Comments Received on the Impact Analysis

    FDA published a preliminary impact analysis in association with the 
proposed SAC regulations on March 30, 2000 (65 FR 16847). The following 
public comments were received on the methodology and projections 
included in that analysis.

General Comments

    (Comment 19) One comment asked, ``Will FDA proceed with SAC if a 
cost savings cannot be achieved?'' The authors added, ``The cost passed 
on to the public may be beneficial if the FDA approved mammography 
sites had distinct advantage and endorsement from the FDA. This would 
serve to enhance and improve quality.''
    Although 42 U.S.C. 263b(q) only states that FDA ``may'' authorize 
States to carry out certification functions and not that it is required 
to do so, the agency has decided to make this option available to 
interested States. This will not change even if it turns out that the 
costs savings estimated under some scenarios in the cost analysis are 
actually cost increases or if the minor cost increases estimated in 
other scenarios are more than expected.
    The agency would like to point out again, however, that 
participation in the SAC program is voluntary on the part of the 
States. The States that have expressed interest in becoming 
certification agencies have in general done so because they believe 
that they can affect cost savings for their facilities while continuing 
to ensure that national standards for mammography are met. If they find 
that they are unable to achieve these cost savings, FDA believes that 
they will not apply to become SAC States or, if they are already SAC 
States under the Demonstration Program, they will withdraw from the 
program.

Use of Nationwide Average Inspection Fees

    (Comment 20) One comment noted that the use of the nationwide 
average per facility cost as the basis for the inspection fee has 
resulted in States with lower costs supporting States with higher costs 
and facilities in the lower cost States shouldering an unfair 
proportion of the fees. A second comment expressed the author's fear 
that this disproportionate financial burden would become greater for 
small States who did not become certifiers as the pool of non-
certifying States becomes smaller.
    FDA agrees that the use of the nationwide inspection fee has 
resulted in the consequences noted in the first comment. The inspection 
support component of the inspection fee (for activities such as 
training and equipping inspectors) is the same for each facility no 
matter where it is located. The direct cost of the inspections, 
however, which is by far the single biggest component of the national 
inspection fee, does vary greatly from State to State. The use of the 
nationwide average fee has resulted in facilities in low inspection 
cost States bearing a disproportionate part of the costs. FDA was aware 
from the beginning of the MQSA program that this situation would be the 
case. However, uncertainties and variables associated with the cost of 
inspection make it difficult to establish a single national fee that 
would, as required by the law, cover the inspection costs without 
overcharging the facilities in the aggregate. To establish a separate 
fee for each State would have vastly magnified the difficulty of this 
task.
    FDA disagrees with the comment that initiation of the SAC program, 
along with the resultant decrease in the pool of non-certifying States, 
will increase the disproportionate financial burden of facilities in 
small States. The agency does recognize that the facilities in the 
remaining non-certifying States, large or small, may have to pay a 
higher inspection fee. As part of the cost analysis, FDA estimated 
increases in the facility inspection fee of approximately $16.52, 
$93.16, and $160.23 would be needed under the conditions of scenarios 
1, 2, and 3, respectively. However, any such increase would actually 
reduce the ``disproportionate'' burden that facilities in some States 
pay as a result of the use of a nationwide inspection fee.
    The reason for this is that, as noted in the cost analysis and in 
the previous answer, the States that are most likely to become SAC 
States are those who by doing so will be able to save their facilities 
money. Thus the States, large or small, with the lower inspection fees 
will most likely be the ones to become SAC States while those with the 
higher inspection fees will likely not. This means that while the 
burden may increase in non-SAC States, its disproportionality will 
decrease.

[[Page 5459]]

Perceived Errors in the Cost Analysis

    (Comment 21) One comment stated that the inspection-related 
functions that FDA provides are the same, regardless of whether the 
facility is located in a SAC or non-SAC State. Therefore, the cost 
associated with these functions and the fee charged should be the same 
regardless of SAC status.
    FDA notes that this is indeed the case. In the SAC States, 
facilities reimburse FDA only for inspection support services through 
the $509 inspection support fee. In the non-SAC States, facilities pay 
an inspection fee of $1,549 per facility plus $204 for each additional 
unit. The inspection fee includes the $509 for the services covered by 
the inspection support fee plus an additional amount to cover the 
average national direct cost of the inspections. Thus, the amount 
charged for inspection support functions is the same whether the 
facility is in a SAC or non-SAC State.
    (Comment 22) One comment stated that FDA did not account for the 
reduction of some of its costs for activities such as issuing 
certificates and performing enforcement activities and, similarly, did 
not account for increased State costs for taking on these functions.
    FDA disagrees. As explained in the preamble to the proposed SAC 
regulations and in more detail in the Regulatory Impact Study, FDA 
estimates in each scenario the reduced costs to FDA of conducting 
functions transferred to the SAC States on a proportional basis. Pre-
SAC, the FDA cost for certification, enforcement, and public 
information was $2,192,000. In scenario 1, for example, FDA would be 
responsible for only 94.1 percent of the pre-SAC facilities, a 5.9 
percent reduction. FDA assumed that its post-SAC costs of these 
activities would be 94.1 percent of the pre-SAC cost or $2,063,143. 
Scenarios 2 and 3 made similar proportional reductions, based upon the 
number of facilities that would be in SAC States. FDA used these 
reduced costs in estimating the savings or increased costs from the SAC 
program. Thus, the statement that FDA did not account for reduced costs 
due to a reduction in its activities is incorrect.
    FDA also took the increased State costs into account. In scenario 
1, where the SAC States were those in the Demonstration Project, the 
agency assumed that the fees charged by the two States involved equaled 
their exact costs for performing the inspections and for handling the 
SAC activities and, therefore, covered their increased costs. FDA 
queried the States that were added in scenarios 2 and 3 to determine if 
they had estimates of what it would cost them to perform SAC 
activities. Unfortunately, although those States were selected on the 
basis of having indicated some interest in becoming certification 
agencies, their planning had not reached the point where they felt 
comfortable providing a cost estimate. Therefore, it was again 
necessary to fall back on proportional costs. If a possible SAC State 
contained 3.6 percent of the nation's mammography facilities, FDA 
assumed as a first estimate that the State could perform its new 
activities, such as issuing certificates, for 3.6 percent of FDA's pre-
SAC baseline costs. FDA further refined this first estimate in each 
State by adjusting the personnel component of the costs to account for 
the difference between the cost of a full time equivalent (FTE) in that 
State and the cost of a FDA FTE.
    The agency acknowledged in its Regulatory Impact Study, that this 
estimation process did not take into account the loss of economy of 
scale that would result from spreading these functions from one large 
entity to several smaller ones. However, there was no valid basis 
available for estimating the impact of the loss of economy of scale.
    (Comment 23) One comment stated that the cost analysis did not 
consider that a State might have costs associated with the performance 
of the MQSA inspections that are not currently being recovered from the 
contract with FDA; if the State became a SAC State, it might want to 
recover these added costs from the facilities. Therefore the potential 
savings to the facilities were overestimated in the cost analysis.
    FDA agrees that this point is a potential source of error but again 
would mention that the agency queried the States for cost information 
and did not get any, except that available for the two States in the 
Demonstration Project from their fee structure. Even in this comment, 
the author gave no indication of how much more reimbursement the States 
might seek from facilities. Without such information, FDA had no basis 
for including a value for the costs mentioned in the comment.

Suggestions for Reducing Costs

    Besides the comment suggesting that training of the inspectors be 
turned over to the SAC States, which we addressed earlier, respondents 
made the following cost saving suggestions.
    (Comment 24) One comment suggested that FDA should review its 
nationwide database and software systems to determine whether such 
elaborate and costly systems are really necessary.
    FDA notes that such reviews have been carried out and will be 
repeated periodically in the future. However, the agency also points 
out that the requirements of MQSA put limitations upon possible 
reductions in its software system. For example, the Senate report 
accompanying the original act indicates that the intent of 42 U.S.C. 
263b(d)(1)(B) is that the agency should avoid, where possible, 
requiring facilities to provide duplicate information to their 
accreditation body and to FDA. This means that the agency's information 
management system must permit electronic transfer of information 
between the accreditation bodies and FDA, because the mechanical 
transfer and organization of such information for 10,000 facilities 
would be extremely cumbersome and expensive. With the accreditation 
bodies, SAC States, and FDA directly connecting to the centralized 
database, interoperability among data systems is increased 
considerably.
    Another advantage to the centralized database is the ability of the 
software system to interface with the Centers for Medicare and Medicaid 
Services' (CMS') data system, which allows facilities to be reimbursed 
under Medicare. FDA also interacts with the National Cancer Institute's 
Cancer Hotline to help women find facilities located near them. The 
agency believes that a centralized database is more effective and 
efficient in carrying out these important functions.
    (Comment 25) One comment noted that FDA should reduce the cost, 
scope, and time of the inspection, recognizing the role of the 
accreditation bodies and medical physicists, and the number and types 
of inspection deficiencies currently being cited.
    FDA believes that there is a misunderstanding on the part of the 
author of this comment as to the intent of Congress in establishing 
both accreditation and inspection functions. The two systems are not 
duplicative but rather complementary. Accreditation bodies are 
responsible for the initial review of mammography facilities, and they 
repeat these evaluations every 3 years for compliance with the quality 
standards established by FDA. They also have unique responsibility for 
conducting reviews of clinical images from the facilities to determine 
if the images meet the image quality standards established by the 
accreditation body.
    Accreditation agencies base their evaluations on material sent to 
them by the facilities. Inspectors, on the other hand, visit the 
facilities and are able to

[[Page 5460]]

check more closely for compliance with these standards. In addition, 
while the accreditation bodies evaluate the facilities every 3 years, 
the inspections are conducted on an annual basis.
    FDA believes that there is great value in having the inspection act 
as an independent check upon the work of the physicist. It is not 
necessary for the inspector to completely duplicate the work of the 
physicist. In fact, the inspection only involves measuring the more 
general indicators of quality, such as phantom image quality and dose. 
These general measurements are sufficient to give an indication if 
there are problems with the equipment performance that had been 
overlooked during the physicist survey or had developed since that 
survey. This permits a more prompt correction of the problems than 
would occur if they were not detected until the next physicist survey.
    FDA does not believe shifting additional responsibilities to the 
accreditation body or physicist will provide the same assurance that 
facilities are meeting uniform minimum national quality standards for 
mammography as does the present division of responsibilities. Moreover, 
the cost reductions from such shifts would be limited since some of the 
larger components of the inspection costs, such as travel to and from 
the facility, will not change even if the inspection is shortened.
    The agency does note, however, that in accordance with MQSA, 
planning is under way for a Demonstration Project to examine the 
question of whether the frequency of the inspections can be reduced 
without compromising mammography quality. Should the study show that it 
is possible to reduce inspection frequency, the cost of inspections 
would be reduced proportionally.

Comments Related to the Inspection Support Fee

    (Comment 26) One comment stated the belief that FDA did not have 
the statutory authority to charge an inspection support fee. The author 
added further that he knew of no other case where a Federal program has 
been delegated to the States where the Federal program still assesses 
the fee to the facilities in the State.
    FDA notes that 42 U.S.C. 263b(r) requires that the agency ``assess 
and collect'' fees to cover the ``costs of inspections * * *'' FDA 
reviewed the question of what costs could be included in the costs of 
inspections at the time the initial inspection fees were established in 
1995 and, most recently, when FDA revised them in 1998 (63 FR 2245, 
January 14, 1998). FDA may seek reimbursement through fees for the 
costs of the actual performance of the inspection (travel costs, 
personnel time, etc.), as well as other inspection costs. These other 
costs include: (1) Overhead costs (on both the State and Federal 
levels); (2) costs of equipping inspectors with measuring instruments; 
(3) calibration and maintenance of those instruments; (4) design, 
programming, and maintenance of data systems for inspection tracking 
and data collection during inspections; (5) training and certification 
of inspectors; and (6) costs of billing facilities for the fees. 
Inspection fees include all of these costs.
    The largest component of the ``costs of inspection,'' the actual 
performance of the inspections and the State overhead related to them, 
will not be FDA expenses in the SAC States. Therefore, it would not be 
lawful for the agency to bill the facilities for them. However, the 
remaining activities included in the ``costs of inspections'' remain 
FDA's responsibility and, by law, facilities must reimburse the agency 
for them. To fulfill this legal requirement, FDA has established the 
inspection support fee.
    FDA conducted research on three major Federal-State programs that 
were similar in scope to the SAC program: Nuclear Regulatory 
Commission, Occupational Safety and Health Administration, and 
Environmental Protection Agency. FDA did not conduct an exhaustive 
study of other Federal agencies that have delegated functions to the 
States. Therefore, FDA is unable to confirm or reject the statement 
that no other Federal agency charges such a fee. The agency notes, 
however, that the activities of each Federal agency are governed by its 
own legislation. Federal agencies that delegate authority must do so in 
accordance with the legislation governing that delegation and FDA is no 
exception. Because MQSA (42 U.S.C. 263b(q)) requires FDA to seek 
reimbursement for all costs of inspections from the facilities, it has 
done so for facilities in SAC States by establishing the inspection 
support fee.
    (Comment 27) Two comments asked for a justification/explanation of 
how the figure of $509 was arrived at for the inspection support fee.
    In October of 1999, FDA sent a letter to all of the State Program 
Directors explaining how FDA determined this fee, including the State 
program that submitted these comments. The starting point for the 
determination was the inspection fee, which had been increased to 
$1,549 per facility (plus $204 for each mammography unit beyond the 
first) in January 1998. FDA explained the basis of that fee in a notice 
published in the Federal Register of January 14, 1998 (63 FR 2245). FDA 
then determined the aggregate costs attributable to the State 
inspection contracts and to the FDA field inspection costs and found 
them to account for $1,040 of the basic fee. The remainder of the 
$1,549, or $509 was thus attributable to FDA's inspection-related 
activities described above (training and equipping of inspectors, 
etc.). Just as FDA periodically re-evaluates its inspection fee in 
light of changing circumstances and costs, it will periodically re-
evaluate its inspection support fee with the result that it may go up 
or down in the future.
    (Comment 28) One comment stated that ``the $509 assessment by FDA 
will result in no cost reduction and as stated could and probably will 
result in higher costs. This is contrary to the statement in the 
Analysis of Impact section that their proposal complies with Executive 
Order 12866 and the Regulatory Flexibility Act.'' A second comment 
likewise stated that the inspection support fee would result in higher 
facility costs. The author pointed out that the cost per inspection in 
his State was $1,421.25; thus, if facilities in his State had to pay a 
$509 inspection support fee, their total costs would have to go up from 
the present inspection fee of $1,549 per facility plus $204 for each 
unit beyond the first.
    FDA disagrees with the first comment's contention that the agency's 
analysis was not in accordance with Executive Order 12866 and the 
Regulatory Flexibility Act. The author of the comment did not provide 
an explanation of why he believed this to be so. The agency thus is 
unable to address any specific concerns on his part but will review its 
analysis process in general.
    Executive Order 12866 directs agencies to prepare an assessment of 
all anticipated costs and benefits of available regulatory alternatives 
and, when regulation is necessary, to select regulatory approaches that 
maximize net benefits. The Regulatory Flexibility Act requires 
determination of whether a proposed regulation may have a significant 
effect on small entities. As summarized in the preamble to the proposed 
SAC regulations, FDA did carry out the required analysis. The agency 
first looked at the cost impact on the public as a whole and then at 
the impact on that portion of the public represented by the mammography 
facilities, all of which the agency deemed to be small entities.

[[Page 5461]]

    The Regulatory Impact Study contains this detailed analysis, which 
was summarized in the preamble to the proposed regulations and within 
this present preamble. Its principal findings were that on a nationwide 
basis there was a potential for reduced costs for mammography 
facilities and the public as a whole from the SAC program. However, the 
agency warned that the potential for savings varies greatly from State 
to State. The reason for the variation was not due to the inspection 
support fee. That fee is the same for all facilities, whether located 
in a SAC State or a non-SAC State where it is a component of the 
inspection fee. The reason for the variation is that the costs of doing 
the inspections themselves vary greatly from State to State.
    In particular, the agency found that while facilities in States 
with low inspection costs would see savings, States with high 
inspection costs would probably see a cost increase for their 
facilities. This conclusion is borne out by the second comment, whose 
author is correct in saying that if his State were to become a SAC 
State, the costs to the facilities in that State would most likely go 
up. But again, the reason for this increase is not the inspection 
support fee but instead is the above average cost of inspections in his 
State. Presently, the facilities in his State benefit from the fact 
that a nationwide inspection fee is charged to facilities in non-SAC 
States. As other comments previously noted, this benefit means that 
facilities in States with lower than average inspections costs pay more 
than their share of the inspections costs while facilities in States 
with higher than average inspection costs pay less than their share. If 
the State referred to in the second comment entered the SAC program, 
the facilities in that State would have to pay the actual inspection 
costs in their State, not the reduced figure made possible by the use 
of an average national fee. Unless that State could find a way to trim 
its inspection costs, the cost to the facility would likely increase.
    In its analysis, FDA also noted that States are not required to 
become certification agencies either by law or the proposed 
regulations. The agency further noted that it is unlikely that a State 
will become a certification agency unless such an action would lead to 
cost savings to its facilities. The author of the second comment also 
supported this belief by stating that if there were an increase in cost 
to their facilities, his State would be unlikely to become a SAC State. 
Again, participation in the SAC program is voluntary.
    In addition, as required by Executive Order 12866, FDA examined 
possible alternatives to the approach laid out in the proposed 
regulations. For reasons given in detail in the Regulatory Impact 
Study, the agency rejected these alternatives. The author of the 
comment did not indicate disagreement with the rejection of the 
alternatives.
    FDA believes that the above information, provided in more detail in 
both the Regulatory Impact Analysis and the preamble to the proposed 
regulations, illustrates that the agency did fulfill its obligations 
under Executive Order 12866 and the Regulatory Flexibility Act.
    (Comment 29) One comment urged that training of the inspectors be 
delegated to the States as a way of reducing the inspection support 
fee. A second comment stated that information transfer was not related 
to inspections but to the maintenance of a national database, therefore 
its costs should not be included in the inspection support fee. A third 
comment disagreed with a FDA statement that a lack of rapid transfer of 
data to FDA from the certification agencies could put the public at 
risk. A fourth comment charged that the costs included in the 
inspection support fee are overestimates, because they were based on 
the start-up costs of training and equipping the initial corps of 
inspectors and initial software development. The comment added that the 
maintenance costs will be much less.
    The agency has previously addressed the first comment in detail. A 
summary of that previous response is that the agency does not believe 
that, given the loss of economies of scale, an individual State can 
provide training of equal quality and breadth but at less cost than the 
FDA program. If more information had been provided on the proposed 
State training program, FDA might have come to a different conclusion, 
but the comment provided no details to support the author's belief that 
money could be saved in this way. In addition, inspector training was 
one of the major topics discussed at a 1998 SAC working group meeting 
in Louisville, KY. The majority of States expressed their desire for 
continued FDA training. FDA remains open to training alternatives after 
the SAC program has been implemented.
    Regarding the second comment, FDA notes that the information 
transfer includes such important components as notifying the State 
inspection programs that a particular facility is certified and thus 
should be inspected. In addition, the uploading of the inspector report 
to the database is the indicator that the facility has been inspected. 
FDA again notes that MQSA seeks to minimize facilities' obligation to 
submit duplicate information; that is, facilities should not be 
required to provide the same information to both the accreditation body 
and the certification agency that is responsible for the inspection 
program. For this reason, the inspection program's only source for 
information on the location, contact person, and other characteristics 
that were provided by the facility to the accreditation body and by 
that body to FDA is from FDA. Therefore, the transfer of that 
information to the certifying State for use in its inspection program 
is another way in which information transfer and inspections are 
related. A third, and perhaps the most important, connection between 
information transfer and the inspection program is the transfer of 
inspection results from an inspector to FDA and the transfer of those 
results back to the inspectors who inspect the facility in following 
years. This last transfer avoids the need to repeat components of the 
inspection, such as review of initial qualifications of personnel that 
would not have changed in the intervening year, and thus permits a more 
streamlined inspection. The information transferred back to the 
inspectors also alerts them to problems that the facility has had in 
the past so that they may determine if the problems have been 
adequately corrected. These examples show that information transfer is 
closely related to the inspections; it, therefore, is appropriate to 
include it in the inspection support fee. SAC States could develop 
their own data systems also, but that would mean increased costs as 
well as problems of interoperability with MQSA's largest accreditation 
body.
    In answer to the third comment, FDA would first mention one 
important example to show that the speed of data transmission is 
important to the public health. Mammography facilities can not be 
reimbursed for examinations under Medicare unless FDA has informed CMS 
that the facility has been given a certificate as an indication that it 
meets the standards. Similarly, if a facility's certificate is 
suspended or revoked or is not renewed, FDA must inform CMS of this 
before reimbursement of the facility under Medicare can be stopped. If 
information from the certification agency concerning the facility's 
certification is delayed in transmission to FDA, unsatisfactory 
facilities may continue to be reimbursed and thus continue to provide 
unsatisfactory examinations. Conversely, facilities that meet the 
standards may be delayed in being cleared for reimbursement, thus

[[Page 5462]]

reducing the availability of adequate mammography.
    Delayed transfer of inspection data also would inhibit FDA's effort 
to ensure that uniform minimum national quality standards are met. It 
would make the national inspection database less effective as a tool 
for speedy identification of undesirable trends related to compliance 
with the quality standards. If an inspection in one State finds a 
problem with personnel or mobile facilities that operate in more than 
one State, delays in transmitting that data to FDA will delay notifying 
the other States of the problem. Finally, it should be mentioned again 
that FDA has an obligation to protect the public health by ensuring 
through its oversight activities that the same uniform minimum national 
quality standards are met in the SAC States as in the non-SAC States. 
Delay in the transmission of inspection data from the SAC States would 
hamper these oversight efforts.
    FDA disagrees with the fourth comment as it applies to training 
costs. The initial task of training approximately 250 inspectors was 
completed in FY 97. As noted in the analysis, the inspection support 
fee was based on FY 98 costs, by which time the training program was in 
the maintenance stage. FDA does agree that the information transfer 
software is still under development and that the costs of the 
information transfer system will decrease when this task is completed. 
There are likely to be other changes as well with the passage of time 
and so FDA does and will continue to periodically reassess the 
inspection support fee, as it does the inspection fee, to see if the 
amount should be adjusted.
    (Comment 30) One comment asked whether certain specific costs 
related to training were included in the training component of the 
inspection support fee. These were: (1) Initial training, (2) 
continuing education and travel for continuing education, (3) travel 
that is currently included under the contract, and (4) annual 
evaluation of the certifying body.
    FDA notes that those initial training costs for new inspectors that 
are related to the actual instruction process are included in the 
inspection support fee. These costs included the expense of the 
contract with a university to provide the first segment of the 
training. These costs also include the cost of providing a training 
facility, mammography units for practice surveys, equipment, and other 
supplies for the last two segments of the training as well as the 
instructor's salaries for those segments.
    The inspection support fee does not include student travel and per 
diem expenses for the training. In addition, it does not include the 
continuing education costs for all inspectors, which is currently 
limited to $1,300 per 3-year period per inspector. The agency is not 
certain what the authors of the comment meant by item 3. If they are 
referring to the costs of the inspector traveling to and from 
inspection sites, the inspection support fee does not cover these 
expenses. All of these costs are, and will continue to be, covered 
under the inspection contracts in the non-SAC States; thus, they are 
not part of the inspection support services. Since State certification 
agencies will not have inspection contracts, they would need to cover 
these costs from fees to facilities or from State appropriations.
    The fourth item asks about FDA's exercise of its oversight function 
through annual evaluations. To date, the cost of oversight functions 
has been covered by Federal appropriations. In order to assure the 
quality and consistency of inspections nationwide, FDA currently 
conducts oversight of all MQSA-certified inspectors and their 
inspections whether they are in an inspection contract State or a SAC 
State. While FDA recovers its inspection oversight costs by fees in 
inspection contract States, FDA presently does not recover them in SAC 
States. In the future, FDA may consider the possibility of transferring 
inspection oversight costs from the inspection fee to the inspection 
support fee.

H. Summary

    The analysis described above shows that the SAC program's economic 
impact on the public and the small entities will vary with how many and 
which States become SAC States. However, even in the scenario with the 
greatest adverse impact, the increased cost to the public was estimated 
to be less than 1 percent of the present cost of the MQSA activities 
that would be transferred to SAC States. The situation with respect to 
the cost to individual mammography facilities was more complicated. For 
facilities in non-SAC States, it appears that the SAC program might 
lead to an increase in their inspection fee. The estimated amount of 
the increase ranges from about 1 percent of the present fee (scenario 
1) up to approximately 10 percent of the present fee (scenario 3). For 
facilities in the SAC States, the estimated impact ranged from the 
total of their inspection support fee and any fee paid to the State 
being about 10 percent less than the present inspection fee (scenario 
1) to being about 8 percent greater (scenario 3). When the average cost 
increase for either SAC or non-SAC facilities in the various scenarios 
was compared to the revenues of a very small mammography facility, it 
never exceeded 1 percent of the facility revenues.
    Although the estimated average savings or increases for facilities 
in both the non-SAC and SAC States vary with the scenario, they all 
represent small changes in the pre-SAC costs to the facilities from the 
inspection fee. However, these averages mask much greater State by 
State variations in savings or added costs. As discussed above, FDA 
believes that a State is unlikely to apply to become a SAC State if the 
costs to its facilities will be significantly increased by that action. 
The facilities in the States that do become SAC States are likely to 
experience a more favorable economic impact than that estimated in this 
analysis. FDA also believes that both quality mammography and the 
reduction of breast cancer mortality will be no less after these 
proposed regulations are implemented than before. Facilities in SAC 
States will have to meet at least the same quality standards as 
facilities in non-SAC States. They will be accredited by the same FDA-
approved accreditation bodies and they will be inspected by the same 
MQSA-certified inspectors whether in the SAC program or not. 
Implementing these regulations will bring the administration of the 
delegated MQSA functions closer to the facilities and the public. With 
their closer proximity, State agencies may be able to respond more 
rapidly to help mammography facilities to improve the quality of their 
services or take enforcement actions against the few facilities that 
present serious public health threats.
    After thorough analysis of the comments received on the impact 
estimates, as described above in comments 19 through 30, FDA concluded 
that none of the comments made a convincing case for changing either 
the methods used in the cost analysis or the conclusions drawn from it.
    Therefore, FDA determines that this rule is consistent with the 
principles set forth in Executive Order 12866, the Regulatory 
Flexibility Act, and the Unfunded Mandates Act. The economic impact on 
the public represented by the mammography facilities will depend upon 
which States choose to enter the program. In the worst case revealed by 
the analysis, a small increase in costs may be experienced. However, 
because States are not likely to enter the program unless such entry 
will be of benefit to

[[Page 5463]]

the facilities within their borders, a cost savings to the public as a 
whole and to mammography facilities is more likely to occur. Finally, 
because participation in this program is voluntary on the part of the 
States and costs incurred by the SAC States can be recouped through 
user fees, there are no unfunded mandates.

VII. Executive Order 13132--Federalism

    Executive Order 13132, dated August 4, 1999, establishes the 
procedures that Federal agencies must follow when formulating and 
implementing policies that have federalism implications. Federalism is 
described as the belief that issues that are not national in scope or 
significance are most appropriately addressed by the level of 
government closest to the people. Regulations have federalism 
implications whenever they have a substantial direct effect on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Whenever a regulation has this result, 
the agency must prepare a federalism assessment.
    The Executive order directs Federal agencies to:
    1. Encourage States to develop their own policies to achieve 
program objectives and to work with appropriate officials in other 
States;
    2. Where possible, defer to the States to establish standards;
    3. In determining whether to establish uniform national standards, 
consult with the appropriate State and local officials as to the need 
for national standards and any alternatives that would limit the scope 
of national standards or otherwise preserve State prerogatives and 
authority; and
    4. Where national standards are required by Federal statutes, 
consult with appropriate State and local officials in developing those 
standards.
    As noted above, the purpose of the legislation was to establish 
minimum national quality standards for mammography. The MQSA replaced a 
patchwork of Federal, State, and private standards with uniform Federal 
standards designed to ensure that all women nationwide receive adequate 
quality mammography services. FDA has worked very closely with State 
officials in developing the national standards for the MQSA program, 
and has sought and obtained input from States at every step of the 
process.
    As noted above, section 354(q) of the PHS Act permits FDA to 
authorize qualified States to: (1) Issue, renew, suspend, and revoke 
certificates; (2) conduct annual facility inspections; and (3) enforce 
the MQSA quality standards for mammography facilities within the 
jurisdiction of the qualified State. FDA retains responsibility for: 
(1) Establishing quality standards, (2) approving accreditation bodies, 
(3) approving and withdrawing approval of State certification agencies, 
and (4) maintaining oversight of State certification programs.
    FDA believes that this division of responsibilities provides for 
necessary uniformity of minimum national standards and, at the same 
time, provides States with maximum flexibility in administering the SAC 
program within their State.
    Also, as previously noted, interested States have had several 
opportunities to participate in the development of this program through 
NMQAAC, the SAC working group, the SAC Demonstration Project and as 
accreditation bodies. States had an additional opportunity to 
participate by submitting comments on the proposed rule. FDA directed a 
mailing of the proposed rule to State health officials to encourage 
their comments on the proposed rule. Comments from the States were 
generally supportive of the rule. As discussed above, where 
appropriate, FDA has revised the final rule to accommodate State 
concerns.
    Participation in the SAC program is voluntary on the part of each 
State but subject to approval by FDA. The Federal Government will 
perform all the necessary functions for implementation of MQSA in 
States that choose not to serve as certification agencies. If a State 
becomes a SAC State, the facilities within its borders will pay only 
the inspection support fee. Further, federally appropriated funds will 
not be used by the SAC State to support the inspection of governmental 
facilities within that State. Facilities will pay an inspection support 
fee to FDA to reimburse the agency, as required by statute, for the 
inspection-related functions that FDA has retained. A State that 
becomes a certification agency will determine how to fund the SAC 
responsibilities. The funding could come from State appropriations, a 
certification fee charged by a SAC State, registration fees or from 
some combination of those sources.
    For the reasons discussed above, FDA believes that this final rule 
is consistent with the federalism principles expressed in Executive 
Order 13132.

VIII. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are 
subject to review by OMB under the PRA (44 U.S.C. 3501-3520). The 
title, description, and respondent description of the information 
collection provisions are shown below with an estimate of the annual 
reporting and recordkeeping burden. Included in the estimate is the 
time for reviewing instructions, searching existing data sources, 
gathering and maintaining the data needed, and completing and reviewing 
each collection of information.
    Title: Requirements for States As Certification Agencies.
    Description: These information collection requirements apply to 
State certification agencies. In order to be an approved certification 
agency, State agencies must submit an application to FDA and must 
establish procedures that give adequate assurance that the mammography 
facilities they certify will meet minimum national standards for 
mammography quality. The certifying agency also must provide 
information about its electronic data management system as well as any 
other information needed by FDA to carry out its ongoing responsibility 
to ensure that the certification agency is complying with the 
requirements. These actions are being taken to ensure the continued 
availability of safe, accurate, and reliable mammography on a 
nationwide basis.
    Respondent Description: State Governments.
    In the proposed rule of March 30, 2000 (65 FR 16847), FDA invited 
comments on the proposed collection of information provisions of the 
SAC regulations. FDA received two public comments addressing these 
provisions. In addition, on May 3, 2000, OMB filed comment.
    One comment recommended that the information collection burden be 
lessened by reducing the amount of information required by 
Sec. 900.21(b)(iii) in the application of a State applying to be a 
certification agency. OMB likewise stated that FDA should consider ways 
to reduce burdens to the States when submitting information for this 
collection. The authors of the public comment suggested that the 
requirements be reduced to:
    (A) Requiring rules and regulations equivalent to subpart B of 
FDA's part 900;
    (B) Information on the education, experience, and training 
requirements of the applicant's professional staff;
    (C) Statement of policies to avoid conflict of interest;
    (D) Description of the applicant's mechanism for handling facility 
inquiries and complaints; and
    (E) Any other information FDA identifies as necessary to make a

[[Page 5464]]

determination on the approval of a State as a certifying agency.
    The authors added that such a change would help correct what they 
perceived to be an undue emphasis on paperwork in the proposed 
regulations at the expense of adequate concern for the health and 
safety of the public.
    A second comment noted that additional mammography review and 
patient notification are two processes for which FDA should not require 
written policies and procedures. The comment also suggested that FDA 
allow State agencies to attest to having adequate staffing, finances, 
and other resources to implement and maintain a mammography 
certification program.
    FDA again notes that the purpose of MQSA is to ensure that uniform 
minimum national standards of quality are met for mammography. Comments 
discussed earlier in the preamble of this final rule expressed concerns 
about whether this goal would continue to be achieved if multiple 
agencies were allowed to carry out the SAC activities. If the goal is 
no longer achieved when a State is authorized as a SAC, then the public 
health and safety would suffer.
    In responding to these comments earlier in this final rule, FDA 
emphasized the importance of its oversight activities in assuring that 
uniform minimum national standards of quality continue to be met for 
mammography. The agency further stressed that this oversight began with 
the review of the original application for approval as a certification 
agency. FDA believes that if there are problems that could hamper the 
State agency from functioning effectively as a certification agency, to 
the extent possible, those problems should be detected and corrected 
before, not after, a State is authorized to be a SAC.
    FDA has been conscious of the paperwork burden from the start and 
has worked to reduce it for States applying to become certification 
agencies under MQSA. At the present time, FDA allows attestation for 
several areas of the SAC application including: (1) Availability of 
sufficient funding and resources to carry out certification activities, 
(2) maintenance of sufficient staffing levels, and (3) several 
inspection and compliance-related provisions. Experience with the MQSA 
accreditation bodies has shown that initial attestation to adequate 
staffing can be problematic. There have been occasions when the 
accreditation body's attestation that it had sufficient staffing later 
proved to be incorrect, perhaps due to insufficient prior analysis of 
its needs. As a result, the accreditation body's efforts to effectively 
carry out its functions were hampered for a period of time until it 
could obtain adequate resources. Learning from its experience with 
accreditation bodies, FDA is seeking assurance that a certification 
agency has adequate staff in place at the time of approval, not several 
months or 1 year later.
    FDA also disagrees with the comment suggesting that FDA reduce the 
information it required to the few categories listed. Under such an 
approach, FDA would have to base a decision on whether to approve the 
State agency as a certification agency without any information about 
the agency's application review and decisionmaking process for facility 
certification. FDA would have no information on whether the State 
agency had policies and procedures governing the notification of 
facilities of certificate denials and expirations or for suspending or 
revoking a facility certificate. The agency would have no information 
on how the State agency planned to ensure that certificates are 
processed within a reasonable timeframe or whether the State had any 
timeframe at all for such actions. FDA would have no information on 
what process, if any, was available for a facility to utilize in 
appealing adverse accreditation decisions.
    Furthermore, the agency would have to make its decision without any 
information about the State agency's plans to inspect facilities 
according to the statutory requirements. There would be no information 
available on how the State agency planned to ensure that deficiencies 
discovered during inspections were corrected. There would be no 
information available on the State agency plans, if any, to apply such 
enforcement actions as additional mammography review or patient 
notification; issues that, as earlier comments showed, are of 
increasing concern. On the support side, there would be no information 
available to FDA to determine if the State's electronic data management 
and analysis system is adequate. FDA's experience with accreditation 
bodies shows that this is an area where there can be major problems 
that can hamper the entire program. In short, if the application were 
reduced to the extent recommended by the comments, FDA would have to 
make its decision on the acceptability of the State agency as a 
certification agency based upon inadequate information. Even the most 
basic information about how the State proposes to conduct its major 
activities (certification, inspection, and compliance) would be missing 
completely.
    FDA further notes that the estimated amount of time to provide the 
information requested was minimal, a one time investment of 50 hours 
per State. Even if the comments were accepted, the potential time 
saving is small and certainly not sufficient to justify the potential 
risk to the public should inadequate information lead the agency to 
approve an applicant that could not carry out its responsibilities. The 
agency concludes, after consideration of the possible options, that it 
has achieved the best possible compromise between the desire to 
minimize the information collection burden and the need to have 
adequate information to carry out its public health responsibilities. 
After considering ways to reduce the burden to the States, FDA has 
concluded that, without the information included in the proposal, the 
agency will be unable to make a valid assessment of the State agency's 
capability to adequately perform the functions outlined above. If the 
agency approves a certification agency that is unable to effectively 
perform these functions, the public health and safety will be adversely 
impacted within that State, perhaps significantly.

                       Table 8.--Requirements for States as Certifiers During Initial Year
                                     (Estimated Annual Reporting Burden)\1\
----------------------------------------------------------------------------------------------------------------
 21 CFR        No. of       Annual Frequency    Total Annual      Hours per                    Total Operating &
 Section    Respondents       per Response       Responses        Response       Total Hours   Maintenance Costs
----------------------------------------------------------------------------------------------------------------
900.21(b         13                 1.0              13              50             650               $130.00
 )
900.21(c         13                 1.0              13              25             325                $65.00
 )(2)
900.22(i          2.0               0.1               0.2             5               1.0               $2.00
 )
900.23            2.0               1.0               2.0            20              40.0              $20.00
900.24(a          2.0               0.05              0.1            62               6.2              $22.00
 )

[[Page 5465]]

 
900.24(a          2.0               0.025             0.05           52               2.6              $10.00
 )(2)
900.24(b          2.0               0.2               0.4            20               8.0               $4.00
 )
900.24(b          2.0               0.05              0.1            52               5.2              $22.00
 )(1)
900.24(b          2.0               0.05              0.1            52               5.2              $20.00
 )(3)
900.25(a          2.0               0.25              0.5             5               2.5               $5.00
 )
                                                                              ----------------------------------
  Total                                                                           1,045.7             $300.00
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.


                       Table 9.--Requirements for States as Certifiers During Initial Year
                                   (Estimated Annual Recordkeeping Burden)\1\
----------------------------------------------------------------------------------------------------------------
  21 CFR         No. of        Frequency of     Total Annual      Hours per                    Total Operating &
  Section    Recordkeepers    Recordkeeping       Records       Recordkeeper     Total Hours   Maintenance Costs
----------------------------------------------------------------------------------------------------------------
900.22(a)           2.0              1.0              2.0             1.0             2.0               $5.00
900.22(d)           2.0              1.0              2.0             1.0             2.0               $5.00
 through
 (h)
900.25(b)           2.0              1.0              2.0             1.0             2.0               $5.00
                                                                              ----------------------------------
  Total                                                                               6.0              $15.00
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.


                 Table 10.--Requirements for States as Certifiers During Second and Later Years
                                     (Estimated Annual Reporting Burden)\1\
----------------------------------------------------------------------------------------------------------------
 21 CFR        No. of       Annual Frequency    Total Annual      Hours per                    Total Operating &
 Section    Respondents       per Response       Responses        Response       Total Hours   Maintenance Costs
----------------------------------------------------------------------------------------------------------------
900.21(i         15.0               1.0               1.5             5               7.5              $15.00
 )
900.23           15.0               1.0              15.0            20             300.0             $150.00
900.24(a         15.0               0.05              0.75           62              46.5             $157.50
 )
900.24(a         15.0               0.025             0.375          52              19.5              $75.00
 )(2)
900.24(b         15.0               0.2               3.0            20              60.0              $30.00
 )
900.24(b         15.0               0.05              0.75           52              39.0             $150.00
 )(1)
900.24(b         15.0               0.05              0.75           52              39.0             $150.00
 )(3)
900.25(a         15.0               0.25              3.75            5              18.75             $60.00
 )
                                                                              ----------------------------------
  Total                                                                             530.25            $787.50
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.


                 Table 11.--Requirements for States as Certifiers During Second and Later Years
                                   (Estimated Annual Recordkeeping Burden)\1\
----------------------------------------------------------------------------------------------------------------
  21 CFR         No. of        Frequency of     Total Annual      Hours per                    Total Operating &
  Section    Recordkeepers    Recordkeeping       Records       Recordkeeper     Total Hours   Maintenance Costs
----------------------------------------------------------------------------------------------------------------
900.22(a)          15                1.0             15.0             1.0            15.0              $37.50
900.22(d)          15                1.0             15.0             1.0            15.0              $37.50
 through
 (h)
900.25(b)          15                1.0             15.0             1.0            15.0              $37.50
                                                                              ----------------------------------
  Total                                                                              45               $112.50
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.

    In contrast to the situation with the economic impact analysis, the 
additional reporting and recordkeeping burden will fall to the State 
Governments that choose to become certification agencies and not the 
approximately 10,000 mammography facilities in the country (all of whom 
are considered to be small entities). The mammography facilities will 
continue to provide the same reports that they are presently providing. 
The bulk of these reports will continue to go to the accreditation 
bodies that are currently receiving them. The occasional report (for 
example, if a facility appeals an adverse decision) that presently goes 
to FDA will, in SAC States, go to the State. The facility recordkeeping 
requirements also are unchanged.
    The total additional reporting and recordkeeping burden on State 
Governments from these regulations depends on the States that choose to 
become certification agencies. Since this choice is voluntary on the 
part of the States, it is impossible to say with certainty how many 
will seek these responsibilities. However, to estimate the possible 
maximum impact, FDA

[[Page 5466]]

assumes that the 15 States used in scenario 3 of the economic impact 
analysis will become certification agencies. This number included the 2 
States currently participating in the SAC Demonstration Project (Iowa 
and Illinois) and 13 additional States.
    Because of the different nature and time, two sets of tables are 
provided. Tables 8 and 9 of this document provide estimates of the 
burden during the first year of the program. During this year, the 
agency assumed that the 13 new States will apply for and obtain 
approval as certification agencies. During that year they will bear the 
initial one time burden associated with application and approval 
process under Sec. 900.21. FDA assumed that the 13 new States will not 
be approved in time to be subject to the ongoing burden associated with 
the evaluation process of Sec. 900.23 during the first year of the 
program. In contrast, Iowa and Illinois, having already received 
approval during the Demonstration Project, will not have to provide 
materials previously submitted, so will not have to bear the initial 
burden associated with Sec. 900.21. However, during the first year, 
they will have the ongoing burdens of the evaluation process 
(Sec. 900.23).
    Tables 10 and 11 of this document provide estimates of the 
recordkeeping and reporting burden in succeeding years. As it was 
assumed that all 15 States will have completed the application and 
approval process by the end of the first year, no State will have the 
initial burden associated with Sec. 900.21 in the succeeding years. All 
will experience the burden associated with the evaluation process 
(Sec. 900.23) and some are expected to have additional burdens 
associated with actions under Secs. 900.22, 900.24, and 900.25.
    With respect to the ongoing burden, based upon FDA's experience 
with accreditation bodies, which must meet a similar requirement, the 
agency estimated that a SAC State would seek approval for a change in 
previously approved standards once every 10 years. The frequency per 
response for reporting under Sec. 900.22(i) thus would be 0.1. Each SAC 
State will be evaluated annually so the frequency per response under 
Sec. 900.23 will be 1.0.
    The agency estimated that each State will have to respond to major 
deficiencies under Sec. 900.24(a) only once every 20 years and minor 
deficiencies under Sec. 900.24(b) only once every 5 years. The 
frequency per response under those requirements are 0.05 and 0.2, 
respectively.
    The hourly reporting burden per response for the State 
certification agency in responding to major deficiencies was estimated 
in the proposed regulations to be 10 hours. This burden is increased 
because of the addition of the requirement that the State certification 
agency inform the facilities that it certifies of the need for it to 
take corrective action. It was assumed that this would be carried out 
by mail and would entail an hourly reporting burden per response of 2 
hours to produce the letter plus a burden of 15 minutes per facility to 
mail it out. The total burden would depend upon the number of 
facilities in the State, which cannot be predicted in advance, so for 
estimation purposes, 200 facilities (approximately the average number 
of facilities per State in the United States) was used. This added 
requirement was thus estimated to increase the hourly reporting burden 
per response by 52 hours, bringing the total hourly reporting burden 
per response under Sec. 900.24(a) to 62 hours.
    In addition, if the State certification agency is unable to correct 
its major deficiencies to FDA's satisfaction and its approval is 
withdrawn, under Sec. 900.24(a)(2), it would have to notify the 
facilities that it has certified. It was assumed that in 50 percent of 
the situations where major deficiencies occurred, the State would be 
unable to correct them, thus the frequency per response of having to 
notify facilities of withdrawal of approval would be 0.05 x 0.50 = 
0.025. The associated hourly reporting burden per response would be the 
same as sending out the original notification to the facilities of the 
State certification agency's need for corrective action, that is, 52 
hours.
    In the cases where there are minor deficiencies, the hourly 
reporting burden per response associated with responding to minor 
deficiencies was estimated in the proposed regulations as 20 hours. FDA 
assumed that the State will, in most cases, make the necessary 
corrections but that once every 20 years (or once out of every four 
times the State has minor deficiencies), the State would face possible 
withdrawal of approval under Sec. 900.24(b)(3). Therefore the frequency 
per response would be 0.05. It was assumed that in all such cases, the 
State certification agency would first be placed on probation, to give 
it the opportunity to correct the deficiencies, before withdrawal of 
approval would be considered. If placed on probation, under 
Sec. 900.24(b)(1), it must notify the facilities that it has certified 
or that seek certification from it, of its probationary status. As with 
previous facility notification letters, it was assumed that the hourly 
reporting burden per response would be 2 hours to produce the letter 
plus 15 minutes per facility to mail it to 200 facilities or 52 hours 
total. In addition, if the State certification agency failed to correct 
its deficiencies and FDA had to withdraw its approval, under 
Sec. 900.24(b)(3), the State certification agency would have to notify 
its facilities of this. The hourly reporting burden per response of 
this notification was again estimated to be 52 hours total, using the 
same assumptions as with the other notification letters.
    Finally, the agency assumed that once every 4 years (a frequency 
per response of 0.25) each SAC State would seek an informal hearing 
under Sec. 900.25(a) in responding to some adverse action against it.
    The estimated recordkeeping burden was related to the maintenance 
of standard operating procedures (SOPs) in several areas. It was 
assumed that each State would spend 1 hour per year maintaining each 
SOP. All of these SOPs would be related to ongoing tasks under 
Secs. 900.22 through 900.25. During the first year (see table 9 of this 
document) the recordkeeping burden would be borne by Iowa and Illinois 
only, in the second and succeeding years (see table 11 of this 
document), by all 15 States. FDA also has corrected an error in the 
proposed rule where it inadvertently omitted Sec. 900.22(h) from the 
recordkeeping tables (see tables 9 and 11 of this document). There is 
no change in burden due to this correction.
    The total estimated annual burden for the final MQSA regulations 
that went into effect on April 28, 1999, was 184,510 hours. Adding a 
subpart C to part 900 (Mammography) to incorporate these proposed 
regulations would lead to an estimated additional annual burden of 
1,051.7 hours during the first year after the regulations were 
effective and an estimated additional burden of 575.25 hours in each 
succeeding year. Again, the actual total annual burden is dependent 
upon how many States voluntarily choose to enter the SAC program. These 
estimates are based upon 15 States becoming SAC States. The estimates 
would be reduced or increased if less than or more than 15 States join 
the program.
    In compliance with the PRA (44 U.S.C. 3507(d)), the agency has 
submitted the information collection provisions of the final rule to 
OMB for review. Prior to the effective date of this final rule, FDA 
will publish a notice in the Federal Register announcing OMB's decision 
to approve, modify, or disapprove the information collection provisions 
in this final rule. An agency may not conduct or sponsor, and a person 
is not required to respond to, a

[[Page 5467]]

collection of information unless it displays a currently valid OMB 
control number.

List of Subjects

21 CFR Part 16

    Administrative practice and procedure.

21 CFR Part 900

    Electronic products, Health facilities, Medical devices, Radiation 
protection, Reporting and recordkeeping requirements, X-rays.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
16 and 900 are amended as follows:

PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

    1. The authority citation for 21 CFR part 16 continues to read as 
follows:

    Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394, 
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.

    2. Section 16.1 is amended in paragraph (b)(2) by numerically 
adding an entry for Sec. 900.25 to read as follows:


Sec. 16.1  Scope.

* * * * *
    (b) * * *
    (2) * * *
    Sec. 900.25, relating to approval or withdrawal of approval of 
certification agencies.
* * * * *

PART 900--MAMMOGRAPHY

    3. The authority citation for 21 CFR part 900 continues to read as 
follows:

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

    4. Section 900.2 is amended by revising the introductory paragraph 
and paragraph (i), and by adding paragraphs (zz), (aaa), and (bbb) to 
read as follows:


Sec. 900.2  Definitions.

    The following definitions apply to subparts A, B, and C of this 
part:
* * * * *
    (i) Certification means the process of approval of a facility by 
FDA or a certification agency to provide mammography services.
* * * * *
    (zz) Certification agency means a State that has been approved by 
FDA under Sec. 900.21 to certify mammography facilities.
    (aaa) Performance indicators mean the measures used to evaluate the 
certification agency's ability to conduct certification, inspection, 
and compliance activities.
    (bbb) Authorization means obtaining approval from FDA to utilize 
new or changed State regulations or procedures during the issuance, 
maintenance, and withdrawal of certificates by the certification 
agency.

    5. Subpart C, consisting of Secs. 900.20 through 900.25, is added 
to read as follows:

Subpart C--States as Certifiers

Sec.
900.20  Scope.
900.21  Application for approval as a certification agency.
900.22  Standards for certification agencies.
900.23  Evaluation.
900.24  Withdrawal of approval.
900.25  Hearings and appeals.

Subpart C--States as Certifiers


Sec. 900.20  Scope.

    The regulations set forth in this part implement the Mammography 
Quality Standards Act (MQSA) (42 U.S.C. 263b). Subpart C of this part 
establishes procedures whereby a State can apply to become a FDA-
approved certification agency to certify facilities within the State to 
perform mammography services. Subpart C of this part further 
establishes requirements and standards for State certification agencies 
to ensure that all mammography facilities under their jurisdiction are 
adequately and consistently evaluated for compliance with quality 
standards at least as stringent as the national quality standards 
established by FDA.


Sec. 900.21  Application for approval as a certification agency.

    (a) Eligibility. State agencies may apply for approval as a 
certification agency if they have standards at least as stringent as 
those of Sec. 900.12, qualified personnel, adequate resources to carry 
out the States as Certifiers' responsibilities, and the authority to 
enter into a legal agreement with FDA to accept these responsibilities.
    (b) Application for approval. (1) An applicant seeking FDA approval 
as a certification agency shall inform the Division of Mammography 
Quality and Radiation Programs (DMQRP), Center for Devices and 
Radiological Health (HFZ-240), Food and Drug Administration, Rockville, 
MD 20850, marked Attn: SAC\1\ Coordinator, in writing, of its desire to 
be approved as a certification agency.
---------------------------------------------------------------------------

    \1\SAC means States as Certifiers.
---------------------------------------------------------------------------

    (2) Following receipt of the written request, FDA will provide the 
applicant with additional information to aid in the submission of an 
application for approval as a certification agency.
    (3) 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;
    (ii) Detailed description of the mammography quality standards the 
applicant will require facilities to meet and, for those standards 
different from FDA's quality standards, information substantiating that 
they are at least as stringent as FDA standards under Sec. 900.12;
    (iii) Detailed description of the applicant's review and 
decisionmaking process for facility certification, including:
    (A) Policies and procedures for notifying facilities of certificate 
denials and expirations;
    (B) Procedures for monitoring and enforcement of the correction of 
deficiencies by facilities;
    (C) Policies and procedures for suspending or revoking a facility's 
certification;
    (D) Policies and procedures that will ensure processing 
certificates within a timeframe approved by FDA;
    (E) A description of the appeals process for facilities contesting 
adverse certification status decisions;
    (F) Education, experience, and training requirements of the 
applicant's professional and supervisory staff;
    (G) Description of the applicant's electronic data management and 
analysis system;
    (H) Fee schedules;
    (I) Statement of policies and procedures established to avoid 
conflict of interest;
    (J) Description of the applicant's mechanism for handling facility 
inquiries and complaints;
    (K) Description of a plan to ensure that certified mammography 
facilities will be inspected according to MQSA (42 U.S.C. 263b) and 
procedures and policies for notifying facilities of inspection 
deficiencies;
    (L) Policies and procedures for monitoring and enforcing the 
correction of facility deficiencies discovered during inspections or by 
other means;
    (M) Policies and procedures for additional mammography review and 
for requesting such reviews from accreditation bodies;
    (N) Policies and procedures for patient notification;
    (O) If a State has regulations that are more stringent than those 
of Sec. 900.12, an

[[Page 5468]]

explanation of how adverse actions taken against a facility under the 
more stringent regulations will be distinguished from those taken under 
the requirements of Sec. 900.12; and
    (P) Any other information that FDA identifies as necessary to make 
a determination on the approval of the State as a certification agency.
    (c) Rulings on applications for 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 
certification standards the applicant will require facilities to meet 
are the quality standards published under subpart B of this part or at 
least as stringent as those of subpart B.
    (2) FDA will notify the applicant of any deficiencies in the 
application and request that those deficiencies be corrected within a 
specified time period. If the deficiencies are not corrected to FDA's 
satisfaction within the specified time period, FDA may deny the 
application for approval as a certification agency.
    (3) FDA shall notify the applicant whether the application has been 
approved or denied. The notification shall list any conditions 
associated with approval or state 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 applicant of the circumstances under which 
a denied application may be resubmitted.
    (d) Scope of authority. FDA may limit the scope of certification 
authority delegated to the State in accordance with MQSA.


Sec. 900.22  Standards for certification agencies.

    The certification agency shall accept the following 
responsibilities in order to ensure quality mammography at the 
facilities it certifies and shall perform these responsibilities in a 
manner that ensures the integrity and impartiality of the certification 
agency's actions:
    (a) Conflict of interest. The certification agency shall establish 
and implement measures that FDA has approved in accordance with 
Sec. 900.21(b) to reduce the possibility of conflict of interest or 
facility bias on the part of individuals acting on the certification 
agency's behalf.
    (b) Certification and inspection responsibilities. Mammography 
facilities shall be certified and inspected in accordance with 
statutory and regulatory requirements that are at least as stringent as 
those of MQSA and this part.
    (c) Compliance with quality standards. The scope, timeliness, 
disposition, and technical accuracy of completed inspections and 
related enforcement activities shall ensure compliance with facility 
quality standards required under Sec. 900.12.
    (d) Enforcement actions. (1) There shall be appropriate criteria 
and processes for the suspension and revocation of certificates.
    (2) There shall be prompt investigation of and appropriate 
enforcement action for facilities performing mammography without 
certificates.
    (e) Appeals. There shall be processes for facilities to appeal 
inspection findings, enforcement actions, and adverse certification 
decision or adverse accreditation decisions after exhausting appeals to 
the accreditation body.
    (f) Additional mammography review. There shall be a process for the 
certification agency to request additional mammography review from 
accreditation bodies for issues related to mammography image quality 
and clinical practice. The certification agency should request 
additional mammography review only when it believes that mammography 
quality at a facility has been compromised and may present a serious 
risk to human health.
    (g) Patient notification. There shall be processes for the 
certification agency to conduct, or cause to be conducted, patient 
notifications should the certification agency determine that 
mammography quality has been compromised to such an extent that it may 
present a serious risk to human health.
    (h) Electronic data transmission. There shall be processes to 
ensure the timeliness and accuracy of electronic transmission of 
inspection data and facility certification status information in a 
format and timeframe determined by FDA.
    (i) Changes to standards. A certification agency shall obtain FDA 
authorization for any changes it proposes to make in any standard that 
FDA has previously accepted under Sec. 900.21 before requiring 
facilities to comply with the changes as a condition of obtaining or 
maintaining certification.


Sec. 900.23  Evaluation.

    FDA shall evaluate annually the performance of each certification 
agency. The evaluation shall include the use of performance indicators 
that address the adequacy of program performance in certification, 
inspection, and enforcement activities. FDA will also consider any 
additional information deemed relevant by FDA that has been provided by 
the certification body or other sources or has been required by FDA as 
part of its oversight mandate. The evaluation also shall include a 
review of any changes in the standards or procedures in the areas 
listed in Secs. 900.21(b) and 900.22 that have taken place since the 
original application or the last evaluation, whichever is most recent. 
The evaluation shall include a determination of whether there are major 
deficiencies in the certification agency's regulations or performance 
that, if not corrected, would warrant withdrawal of the approval of the 
certification agency under the provisions of Sec. 900.24, or minor 
deficiencies that would require corrective action.


Sec. 900.24  Withdrawal of approval.

    If FDA determines, through the evaluation activities of 
Sec. 900.23, or through other means, that a certification agency is not 
in substantial compliance with this subpart, FDA may initiate the 
following actions:
    (a) Major deficiencies. If, after providing notice and opportunity 
for corrective action, FDA determines that a certification agency has 
demonstrated willful disregard for public health, has committed fraud, 
has failed to provide adequate resources for the program, has submitted 
material false statements to the agency, has failed to achieve the MQSA 
goals of quality mammography and access, or has performed or failed to 
perform a delegated function in a manner that may cause serious risk to 
human health, FDA may withdraw its approval of that certification 
agency. The certification agency shall notify, within a time period and 
in a manner approved by FDA, all facilities certified or seeking 
certification by it that it has been required to correct major 
deficiencies.
    (1) FDA shall notify the certification agency of FDA's action and 
the grounds on which the approval was withdrawn.
    (2) A certification agency that has lost its approval shall notify 
facilities certified or seeking certification by it, as well as the 
appropriate accreditation bodies with jurisdiction in the State, that 
its approval has been withdrawn. Such notification shall be made within 
a timeframe and in a manner approved by FDA.
    (b) Minor deficiencies. If FDA determines that a certification 
agency has demonstrated deficiencies in performing certification 
functions and responsibilities that are less serious or more limited 
than the deficiencies in

[[Page 5469]]

paragraph (a) of this section, including failure to follow the 
certification agency's own procedures and policies as approved by FDA, 
FDA shall notify the certification agency that it has a specified 
period of time to take particular corrective measures as directed by 
FDA or to submit to FDA for approval the certification agency's own 
plan of corrective action addressing the minor deficiencies. If the 
approved corrective actions are not being implemented satisfactorily or 
within the established schedule, FDA may place the agency on 
probationary status for a period of time determined by FDA, or may 
withdraw approval of the certification agency.
    (1) If FDA places a certification agency on probationary status, 
the certification agency shall notify all facilities certified or 
seeking certification by it of its probationary status within a time 
period and in a manner approved by FDA.
    (2) Probationary status shall remain in effect until such time as 
the certification agency 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, or
    (3) If FDA determines that a certification agency that has been 
placed on probationary status is not implementing corrective actions 
satisfactorily or within the established schedule, FDA may withdraw 
approval of the certification agency. The certification agency shall 
notify all facilities certified or seeking certification by it, as well 
as the appropriate accreditation bodies with jurisdiction in the State, 
of its loss of FDA approval, within a timeframe and in a manner 
approved by FDA.
    (c) Transfer of records. A certification agency that has its 
approval withdrawn shall transfer facility records and other related 
information as required by FDA to a location and according to a 
schedule approved by FDA.


Sec. 900.25  Hearings and appeals.

    (a) Opportunities to challenge final adverse actions taken by FDA 
regarding approval of certification agencies or withdrawal of approval 
of certification agencies 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 certification is entitled to an 
appeals process from the certification agency. The appeals process 
shall be specified in writing by the certification agency and shall 
have been approved by FDA in accordance with Secs. 900.21 and 900.22.

    Dated: October 26, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-2750 Filed 2-5-02; 8:45 am]
BILLING CODE 4160-01-S