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