[Federal Register: March 30, 2000 (Volume 65, Number 62)]
[Proposed Rules]               
[Page 16847-16859]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30mr00-24]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16 and 900

[Docket No. 99N-4578]

RIN 0910-AB98

 
State Certification of Mammography Facilities

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to 
implement the patient notification provisions of the Mammography 
Quality Standards Act of 1992 (the MQSA). This action will permit FDA 
to authorize individual States to certify mammography facilities, to 
conduct the inspection of the facilities, to enforce the MQSA quality 
standards, and to administer other related functions. FDA retains 
oversight responsibility for the activities of the States to which this 
authority has been delegated and mammography facilities certified by 
those States must continue to meet the quality standards established by 
FDA for mammography facilities nationwide. The document proposes 
procedures for application, approval, evaluation, and withdrawal of 
approval of States as certification agencies. It also proposes 
standards to be met by States receiving this authority.

DATES: Submit written comments on the proposed rule by June 28, 2000. 
Written comments on the information collection requirements should be 
submitted by May 1, 2000.

ADDRESSES: Submit written comments on the proposed rule to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. 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. The Regulatory 
Impact Study (RIS) and cost analysis is available at the Dockets 
Management Branch for review between 9 a.m. and 4 p.m., Monday through 
Friday. Requests for copies of the RIS should be submitted to the 
Freedom of Information Staff (HFI-35), Food and Drug Administration, 
5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:  Ruth A. Fischer, 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

    The 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. The MQSA required that to provide 
mammography services legally after October 1, 1994, all mammography 
facilities, except facilities of the Department of Veterans Affairs, 
had 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. 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. On October 9, 1998, the Mammography Quality 
Standards Reauthorization Act (the MQSRA) (Public Law 105-248) was 
enacted to extend the MQSA through fiscal year 2002.

A. Provisions of the MQSA

    The key requirements of MQSA to be met by the facilities in order 
to receive and maintain their FDA certification 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 standards 
established by the agency for accreditation bodies and that continue to 
pass annual FDA reviews of their activities. As part of the 
accreditation process, the accreditation body must evaluate for quality 
actual clinical mammograms from each unit in the facility, and 
determine that 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 by October 1, 1994, 
the date by which mammography facilities had to have an FDA certificate 
in order to continue lawfully providing mammography services. In the 
Federal Register of October 28, 1997 (62 FR 55852), more comprehensive 
facility quality standards and accreditation body requirements were 
published, which became effective on April 28, 1999. Five accreditation 
bodies, the American College of Radiology (ACR) and the States of 
Arkansas, California, Iowa, and Texas, have been approved by FDA to 
accredit mammography facilities. Approximately 250 Federal and State 
inspectors were trained and certified to conduct the MQSA inspections, 
and the 5th year of inspections has now begun. The number of certified 
mammography facilities varies with time but typically is slightly under 
10,000.

C. Role of the States

    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 the borders of the 
accrediting States. Most of the FDA-certified inspectors are State 
personnel who, working under contract with FDA, have conducted the 
great majority of the inspections. FDA currently has contracts for the 
performance of inspections with 46 States, the District of Columbia, 
Puerto Rico, and New York City.
    MQSA also provides for an even more significant State role in the 
MQSA program. In accordance with section 354(q) of the Public Health 
Service Act (the PHS Act) (42 U.S.C. 263b(q)), States

[[Page 16848]]

may become the certifying agency for mammography facilities operating 
within their borders and also may be delegated other important 
responsibilities, such as the conduct of the inspections of the 
facilities they certify and enforcement of MQSA quality standards. The 
purpose of this proposed rule is to establish the requirements to be 
met by States as Certification Agencies (commonly known as and 
hereafter referred to as States as Certifiers (SAC's)) and the 
procedures for the application, approval, and withdrawal of approval of 
SAC's.

D. The Patient Notification Provisions

    Section 354(q) of the PHS Act allows FDA to delegate to qualified 
States, the authority for: (1) Issuing, renewing, suspending, and 
revoking certificates, (2) conducting annual facility inspections and 
followup inspections, and (3) implementing and enforcing the MQSA 
quality standards for mammography facilities within the jurisdiction of 
the qualified State.
    To be approved, a State must: (1) Have enacted laws and issued 
regulations equivalent to 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.
    FDA is to retain exclusive responsibility for: (1) Establishing 
quality standards, (2) approving accreditation bodies, (3) approving 
and withdrawing approval of State certification agencies, and (4) 
maintaining oversight over State certification programs. Moreover, FDA 
retains authority to suspend or revoke the certificate of facilities 
within an approved State, and to take other administrative and judicial 
actions against such facilities provided for in the MQSA.

E. Development of the SAC Proposed Rule

    This proposed rule covers procedures for application for FDA 
approval as a certification agency and the requirements and 
responsibilities of such agencies. It also establishes procedures for 
oversight of approved States and for withdrawal of approval. Four 
sources of information were relied upon by FDA in developing these 
regulations, in addition to the expertise and research of FDA 
personnel.
    First, the proposed SAC program was discussed with the National 
Mammography Quality Assurance Advisory Committee (NMQAAC). NMQAAC is a 
committee of health professionals, whose work focuses significantly 
upon mammography, and of representatives of consumer groups and State 
agencies. This committee has the responsibility of advising FDA on 
regulatory requirements implemented under the MQSA. Advice about the 
direction of the SAC program and the content of the proposed rule was 
provided by NMQAAC at meetings held in September 1994 and July 1996. 
NMQAAC has received updates on the proposed program at subsequent 
meetings.
    Second, the SAC program and the proposed rule were discussed in 
meetings of a SAC Working Group formed by FDA in accordance with 21 CFR 
20.88(e). Although NMQAAC was a source of valuable information from a 
wide segment of the mammography community, FDA partnership with the 
States would be an essential key to the future success of the SAC 
program. This second group was intended to serve as a means to begin 
building that partnership. 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. The State participants were chosen with the goal of 
obtaining input from all regions of the country and from States that 
are MQSA accreditation bodies. The Working Group met in June 1996, 
January and September 1997, May and November 1998, and May 1999 and has 
contributed greatly to the development of the proposed rules.
    Third, FDA's experience over the last 4 years with the 
accreditation bodies has greatly influenced the proposed rule because 
there is similarity with respect to the objectives targeted, the 
problems to be solved, and the oversight needed for the delegation of 
accreditation and certification authority.
    Finally, in August 1998, FDA established a SAC Demonstration 
Project in which certification authority was delegated to approved 
States for a 1 year period, with the possibility of renewal for a 
second year. The States of Illinois and Iowa applied for and received 
approval from FDA to participate in the demonstration project. The 
experience gained proved to be valuable in the development of the long 
term SAC program.

II. Provisions of the Proposed Rule

    FDA is proposing to add subpart C, entitled States as Certifiers, 
to part 900 (21 CFR part 900--Mammography). This subpart will contain 
sections defining: (1) The requirements for application by a State for 
approval as a certification agency, (2) the requirements to be met and 
the responsibilities of the States delegated certification authority, 
(3) the process 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 State as a certification agency, and 
(5) opportunities for hearings and appeals related to adverse actions 
taken by FDA with respect to certification agencies. FDA is also 
proposing conforming amendments to Sec. 16.1(b)(2) (21 CFR 16.1(b)(2)), 
which deals with hearing procedures, and to Sec. 900.2 Definitions.
    In proposing this rule, and in all activities related to MQSA, FDA 
is guided by the intent of the MQSA to ensure access to high quality 
mammography services for all women in the United States. FDA believes 
that women in States with certification authority can be provided 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 inspection fee 
in States whose inspection costs are lower than the national average 
that is used to calculate the present national inspection fee. Other 
cost savings may be achieved through States being able to combine the 
MQSA program with other State mammography initiatives.

A. Scope

    Proposed Sec. 900.20 describes the scope of subpart C. The new 
subpart establishes procedures for a State to apply to become an FDA-
approved certification agency for mammography facilities. It further 
defines the responsibilities to be met by the certification agencies 
and the oversight procedures to be used by FDA to ensure that the 
responsibilities are adequately fulfilled.

B. Application for Approval as a Certification Agency

    Before FDA can approve a State as a certifying agency, the agency 
must have assurance that the State can adequately meet the associated 
responsibilities. Proposed Sec. 900.21 summarizes the information to be 
provided by the State to FDA to enable the agency to make an informed 
decision on the likelihood that the State will be able to adequately 
carry out certification responsibilities. Under section 354(q) of the 
PHS Act, only FDA may establish quality standards. States

[[Page 16849]]

retain authority under paragraph (m), however, to enact and enforce 
standards ``as stringent as'' those established under MQSA. The 
application must include a detailed description of the mammography 
quality standards the applicant will require facilities to meet and, if 
different from FDA's quality standards, information substantiating the 
equivalence of those standards to FDA standards. The application also 
must include information about the applicant's decision making process 
for issuing, suspending, and revoking a facility's certificate and its 
procedures for notifying facilities of inspection deficiencies and the 
monitoring of the correction of those deficiencies. Finally, 
information must be provided about the resources the State can devote 
to the program, including information about: (1) The qualifications of 
the State's professional staff; (2) adequacy of the State's staffing, 
finances, and other resources; (3) the State's ability to provide data 
and reports in an electronic format compatible with FDA data systems; 
and (4) the adequacy of the State's enforcement authority and 
compliance mechanisms.
    FDA also plans to issue application guidance to prospective State 
certification agencies to further assist them in preparing the 
necessary materials and supporting documentation.
    Proposed Sec. 900.21(c) also provides a general description of the 
process that FDA will follow in arriving at a decision on whether or 
not to accept a State as a certification agency. Proposed 
Sec. 900.20(d) notes that FDA may limit the types of facilities for 
which certification authority is being granted; for example, FDA does 
not expect to grant certification authority for Federal facilities to 
States.
    FDA specifically invites comments on the nature and extent of the 
information collection burden that is included in Sec. 900.21

C. Standards for Certification Agencies

    Proposed Sec. 900.22 proposes requirements and responsibilities to 
be met by States that have been approved as certification agencies.
    Proposed Sec. 900.22(a) would require 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.
    Proposed Sec. 900.22(b) would require that the statutory and 
regulatory requirements used by the certification agencies for the 
certification and inspection of mammography facilities be those of MQSA 
and part 900 or appropriate more stringent requirements.
    Proposed Sec. 900.22(c) would require 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 MQSA quality standards.
    Proposed Sec. 900.22(d) would require 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.
    Proposed Sec. 900.22(e) would require that there be means by which 
facilities can appeal adverse certification decisions made by a 
certification agency.
    Proposed Sec. 900.22(f) would require that approved certification 
agencies have processes for requesting additional mammography review 
from accreditation bodies for issues related to mammography image 
quality and clinical practice.
    Proposed Sec. 900.22.(g) would require that the certification 
agencies have procedures for patient notification for situations when 
the certification agency has determined that mammography quality has 
been compromised to the extent that there may be a serious risk to 
human health.
    Proposed Sec. 900.22(h) would require that approved certification 
agencies have processes to ensure the timeliness and accuracy of 
electronic transmission of inspection data and facility certification 
status in a format and timeframe determined by FDA. FDA believes that 
such electronic transfer is necessary in view of the need to transmit 
large amounts of data rapidly among the accreditation bodies, 
certification agencies, FDA, and other involved agencies such as the 
Health Care Financing Administration (HCFA). Without a rapid transfer 
of certification information, facilities may not be able to operate for 
a period of time or may face delays for Medicare and Medicaid 
reimbursement because HCFA has not been informed of their certification 
status. Similarly, without rapid transfer of data concerning inspection 
deficiencies and corrective actions, members of the public may be put 
at risk for an unacceptable period.
    Proposed Sec. 900.22(i) would require FDA authorization for any 
changes a certification agency proposes to make to any standards FDA 
previously accepted under Sec. 900.21 or Sec. 900.22. FDA believes that 
this is necessary to assure the standards for certification agencies 
continue to be met.

D. Evaluation

    Section 900.23 proposes standards for the annual evaluation of the 
performance of each certification agency. The evaluation will be based 
on performance indicators related to the adequacy of the certification 
agency's performance in the areas of certification, inspection, and 
compliance. FDA plans to provide further guidance on the nature of 
these performance indicators. The experience gained during the SAC 
Demonstration Project is expected to be of significant value in 
developing this guidance.
    During the evaluation, FDA will consider the responsiveness, 
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 shall include a determination of whether 
there are major deficiencies in the certification agency's performance 
that, if not corrected, would warrant withdrawal by FDA of the agency's 
approval. The evaluation will also include identification of any minor 
deficiencies that require corrective action. In performing these 
evaluations, FDA will use the results of annual inspections, 
information from required reports from certification agencies, and any 
other appropriate source of information. For example, the agency may 
visit facilities or certification agencies as part of the evaluation 
and may request additional information from the certification agency or 
other sources.

E. Withdrawal of Approval

    In Sec. 900.24, FDA has proposed actions to be taken if evaluations 
carried out under proposed Sec. 900.23 or other information leads to a 
determination that a 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 approval of the certification agency. Examples of major 
deficiencies include commission of fraud, willful disregard for the 
public health, failure to provide adequate resources for the program, 
performing or failing to perform a delegated function in a manner that 
may cause serious risk to the public health, or the submission of 
material false statements to FDA. If there are less serious 
deficiencies, termed minor deficiencies in the

[[Page 16850]]

regulations, FDA will establish a definite time period during which the 
certification agency must either take corrective measures as directed 
by FDA or submit to FDA for its approval the certification agency's own 
plan of corrective action. FDA may place the certification agency on 
probationary status while the minor deficiencies are being addressed. 
Probationary status would be used in situations where the certification 
agency is not implementing the corrective action satisfactorily or 
within the established schedule. FDA also may withdraw approval of the 
agency as a certification agency if corrective action is not taken or 
if the identified minor deficiencies have not been eliminated within 
the established schedule.
    While an 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 
and appropriate accreditation bodies of its change in status. 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. The goal will be to return 
the facilities within its jurisdiction to the FDA certification program 
without an interruption in their certification status.

F. Hearings/Appeals

    Under proposed Sec. 900.25, FDA will provide 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 
of that certification agency. The opportunity for a hearing shall be 
provided in accordance with 21 CFR part 16. Certification agencies also 
are required to provide facilities that have been denied certification 
with the opportunity to appeal that decision. The appeals process of 
each certification agency shall be specified in writing and shall have 
been approved by FDA in accordance with proposed Sec. 900.21.

G. Conforming Amendments

    A conforming amendment to Sec. 16.1 is proposed to add Sec. 900.25 
to the list of provisions under which regulatory hearings are 
available.
    Conforming amendments to Sec. 900.2 are also proposed to indicate 
that the definitions in that section applied to subpart C, as well as 
to subparts A and B of part 900. Two definitions, Sec. 900.2 (zz) 
Certification agency and (aaa) Performance indicator, are proposed for 
addition to the definition list. In adding these definitions, FDA 
proposes to depart from its earlier practice of placing the definitions 
in alphabetical order and to simply add the new definitions to the end 
of the list. This was done to avoid the necessity of making numerous 
changes in the citations of the definitions in subparts A and B with 
all the potential for confusion and error that such citation changes 
would entail.

III. 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.

IV. Analysis of Impacts

    FDA has examined the impact of the proposed rule under Executive 
Order 12866, under the Regulatory Flexibility Act (Public Law 96-354), 
and under the Unfunded Mandates Reform Act (Public Law 104-4). 
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 (including potential economic, environmental, 
public health and safety, and other advantages, distributive impacts, 
and equity). The Regulatory Flexibility Act requires agencies to 
analyze regulatory options that would minimize any significant impact 
of a rule on small entities. The Unfunded Mandates Reform Act requires 
(in section 202) that agencies prepare an assessment of anticipated 
costs and benefits before proposing any rule that may result in an 
expenditure in any one year by State, local, and tribal governments, in 
the aggregate, or by the private sector, of $100 million (adjusted 
annually for inflation). The agency has conducted preliminary analyses 
of the proposed rule, and has determined that the proposed rule is 
consistent with the principles set forth in the Executive Order and in 
these two statutes. The regulatory impact study and cost analysis that 
details the agency's calculation of these economic aspects is available 
at the Dockets Management Branch for review.
    FDA realized from the beginning 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 will be entirely voluntary on 
the part of the States, FDA cannot determine in advance which States 
will decide to become SAC States. The first assumptions that had to be 
made, therefore, were related to which States might become SAC States. 
Three separate scenarios were used to establish the possible range of 
the impact of these proposed regulations.
    In scenario 1, FDA assumed only the States of Iowa and Illinois 
would choose to participate in the program. Iowa and Illinois are the 
current participants in the SAC Demonstration Project and have 
indicated a strong interest in continuing. In scenario 2, FDA assumed 
that Iowa and Illinois would be joined in the SAC program by six 
additional States. The States chosen have in the past indicated 
significant interest in becoming SAC States when the program is fully 
implemented. In 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 geographical distribution and the number of 
mammography facilities within their borders ranges from relatively 
large to relatively small. Thus, although the basis of selection was 
FDA's perception of the State's interest, the resulting groups are 
representative of the country as a whole.
    The costs or savings from the SAC program were estimated by 
comparing the pre-SAC costs for performing the functions that would be 
affected by the program with the costs of performing them under each 
scenario. The proposed regulations would permit FDA to delegate to the 
SAC States the responsibility (with FDA oversight) for the function of 
MQSA certification as it applies to non-Federal mammography facilities 
within their borders, and shared responsibility for other functions 
such as enforcement. Control and execution of the annual inspections of 
mammography facilities also would be delegated to the SAC States; 
however, to permit effective oversight of an SAC State's inspection 
program, FDA would retain responsibility for inspection-related support 
functions including training the inspectors, calibration of their 
equipment, and functions related to the transfer of information

[[Page 16851]]

electronically between the States and FDA. Underlying all of these 
functions is the significant task of keeping the public and facilities 
informed about the MQSA activities. Because of the importance of this 
public information task, its cost was considered separately in the 
analysis.
    Funding to support the MQSA activities pre-SAC comes from two 
sources: User fees and appropriated funds. Paragraph (r) of the MQSA 
provides for user fees to cover costs related to inspections, which FDA 
collects from each non-governmental mammography facility inspected in a 
year. Presently, the inspection fee is $1,549 per facility plus an 
additional $204 per mammography unit for each unit beyond the first 1 
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 facility 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 not to enter the 
SAC program.
    If a State becomes a SAC State, the non-governmental facilities 
within that State will pay an inspection support fee to FDA to 
reimburse the agency, as required by the statute, for the inspection-
related services that the agency has provided. This 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 of $509 will also be provided from appropriated funds 
for each governmental facility inspection within the State.
    The SAC State will determine how the responsibilities that it has 
assumed will be funded. The funding could come from State 
appropriations, from a fee charged by the State either under its own 
authority or under paragraph (r) of the MQSA, or some combination of 
these sources.
    The baseline value (given in tables 1 and 2 of this document) used 
for the pre-SAC cost of the MQSA functions to be delegated to the SAC 
States is a total of the costs of the individual functions pre-SAC 
determined from review of recent FDA budgets. The total costs to the 
public as a whole under each of the three scenarios will be:
Post-SAC Costs to the public = Costs in non-SAC States + Costs in SAC 
States
    The costs in non-SAC States are calculated as follows:
Costs in non-SAC States = Inspection Program Costs + Certification 
Costs + Compliance Costs + Public Information Costs
    The Inspection Program Costs term was estimated for non-SAC States 
by subtracting from the baseline inspection costs the total of the 
inspection fees that will no longer be paid by the facilities (or, in 
the case of governmental facilities, from appropriated funds) located 
within the SAC States in each scenario. The other costs were obtained 
by multiplying the baseline costs for those functions by the percentage 
of the nation's mammography facilities remaining in non-SAC States. In 
other words, it was assumed, for example, that if only 80 percent of 
the nation's facilities remain in non-SAC States, the cost of carrying 
out these functions would be only 80 percent of the pre-SAC cost.
    The costs in SAC States are calculated as follows:
Costs in SAC States = FDA Inspection Support Costs + State Costs
    FDA's Inspection Support Costs term was obtained by multiplying the 
inspection support fee by the number of facilities within the SAC 
States that would be expected to be inspected during the year (in all 
these calculations an inspection rate of 82.8 percent was assumed in 
both non-SAC and SAC States, for reasons discussed in the regulatory 
impact study and cost analysis available at the Dockets Management 
Branch). The State Costs assumed by the SAC States could be funded 
either by State appropriations or a fee charged by the State under 
State law or the MQSA. If fees are used, they could be State 
certification fees, inspection fees collected by States under State 
law, inspection fees collected by States under MQSA, or some 
combination of these.
    The two States currently in the SAC Demonstration Project both 
decided to fund their activities through a fee. Iowa set its fee at 
$850 per facility plus $300 for each additional unit beyond the first 
in the facility. Illinois's fee is $750 per facility. Both States 
decided to charge these fees to all non-Federal facilities within their 
borders, whether they were inspected in a given year or not, since the 
functions being funded are not all related to inspections. For scenario 
1, the Total of Other Fees term was obtained by multiplying the number 
of facilities in the two States (and in Iowa, the number of additional 
units) by the fee or fees of that State.
    The SAC States in scenarios 2 and 3, other than Iowa and Illinois, 
are not presently SAC States. There is no established fee, therefore, 
to serve as the basis for estimating their costs. The State Costs term 
thus had to be estimated using a series of assumptions. The equation 
used for the estimation was:
State Costs = Inspection Costs + Inspection Support Costs + 
Certification Costs + Enforcement Costs + Public Information Costs
    To obtain the inspection costs term, it was assumed that the 
average cost per inspection would be the same as the State is presently 
receiving for performing inspections under contract with FDA; the 
inspection cost term would be the average per facility cost times the 
number of facilities inspected. The inspection support costs was the 
cost of the inspection-support services included in the delegation to 
the States. Like the last three terms in the equation, this cost 
related to functions that were new to the States. For all four of these 
terms, the estimate of cost was made by multiplying the pre-SAC 
baseline cost for the function by the percentage of the nation's 
facilities in each SAC State. For example, if 5 percent of the nation's 
facilities were located in a particular SAC State, the Certification 
Cost in that State would be estimated as five percent of the pre-SAC 
cost for the entire nation. For the personnel components of the costs 
of these functions, further correction factors were applied to take 
into account the fact that the cost of a State Full Time Employee (FTE) 
is typically less than that of a Federal FTE.
    The analysis results summarized in tables 1 and 2 of this document 
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 that 
savings is not proportional to either the number of States in the 
program or the number of facilities. In fact, the estimated savings in 
scenario 3, with 15 SAC States including 54 percent of the nation's 
facilities, is less than in scenario 2, with 8 States and a little more 
than 26 percent of the facilities.

[[Page 16852]]



          Table 1.--Cost of Certification in Non-Sac\1\ States
------------------------------------------------------------------------
 Scenario   Non-SAC States Facilities (%)       Non-SAC States Cost
------------------------------------------------------------------------
Baseline                100.0                   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 of Certification in Non-Sac\1\ States
----------------------------------------------------------------------------------------------------------------
                   SAC States
    Scenario     Facilities (%)       SAC States Costs             Total Costs             Savings to Public
----------------------------------------------------------------------------------------------------------------
Baseline               0                      0                 16,067,499                          0
1                      5.9              709,870                  5,850,432                    217,067
2                     26.2            3,650,563                 15,492,226                    575,273
3                     54.0            8,180,723                 15,575,444                   492,055
----------------------------------------------------------------------------------------------------------------
\1\ SAC means States as certifiers.

    The explanation of why these results show the pattern that they do 
begins with the realization that the SAC program will save (or cost) 
the public more money than the pre-SAC program depending upon whether 
SAC States can carry out their delegated functions more economically 
than they 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 a 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 a net savings in scenario 1. The inspection costs in the States 
added in scenario 2 range from lower than to a little higher than the 
average. Again, it is not surprising to find that there is a net 
savings and, since 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, three of 
the States added to scenario 3 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.
    One additional factor had to be taken into account to provide a 
more accurate evaluation of the cost to the public of the proposed SAC 
regulations. The initial round of calculations assumed that the 
inspection fee charged to the facilities in the non-SAC States will not 
change as the result of some States becoming SAC States. This is not 
necessarily true. The funds available for the FDA inspection program in 
the non-SAC States will decrease as more States become SAC States 
because facilities in SAC States will only be paying FDA the inspection 
support fee instead of the higher inspection fee. On the other hand, 
the cost of the FDA inspection program will also decrease because it 
will no longer include the cost of inspecting the facilities in the SAC 
States. However, as noted, the inspection cost varies greatly from 
State to State. If predominantly low inspection cost States become SAC 
States, the reduction in cost of the MQSA inspection program in the 
non-SAC States plus the inspection support fee paid by the SAC State 
facilities may not be as great as the reduction in the funds available 
to FDA to fulfill its MQSA inspectional responsibilities. In that case 
it will be necessary to raise the inspection fees in the non-SAC States 
or the inspection support fee for SAC State facilities, or both, 
because the FDA inspection program must be fee supported. On the other 
hand, if predominantly high inspection cost States become SAC States, 
the reverse would be true and it may be possible to reduce the 
inspection fees in the non-SAC States.
    To refine the analysis, the funds needed by FDA to carry out its 
post-SAC MQSA inspection responsibilities were compared to the funds 
that would be available if the inspection and inspection support fees 
remained unchanged. It was found that 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. The following table 3 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.

[[Page 16853]]



       Table 3.--Impact of Non-SAC\1\ State Inspection Fee Change
------------------------------------------------------------------------
                                                Savings/(Cost) After Fee
     Scenario       Savings Before Fee Change            Change
------------------------------------------------------------------------
1                         $217,067                    $89,474
2                         $575,273                    $11,563
3                         $492,055                ($113,173)
------------------------------------------------------------------------
\1\ SAC means States as certifiers.

    The above discussion provides estimates of the economic impact of 
the proposed SAC regulations on the public in general. In accordance 
with the Regulatory Flexibility Act, the economic impact on the portion 
of the public represented by the small entities was also evaluated. All 
of the approximately 10,000 mammography facilities in the country were 
considered to be small entities for the purposes of the analysis.
    In the case of facilities in non-SAC States, any economic impact in 
the scenarios examined would appear as an increase or decrease in their 
inspection fee. As noted above, with the scenarios used in the 
analysis, additional funds would be needed for FDA's post-SAC MQSA 
inspection program. The decision on whether these additional funds 
would come from an increase in the inspection fee paid by non-SAC State 
facilities, the inspection support fee paid by SAC State facilities, or 
both would depend upon which fee(s) was (were) failing to cover the 
cost of the activities for which it was being assessed. However, as a 
worst case estimate for non-SAC State facilities, it was assumed that 
100 percent of the needed funds would have to come from an increase in 
inspection fee. If the changes in fee are limited to changes in the 
facility inspection fee, leaving the fee for extra units unchanged, 
increases of $16.52, $93.16, and $160.23 respectively would be needed 
in scenarios 1, 2, and 43. Even the largest estimated increase, that 
for scenario 3, was only about 10 percent of the present $1,549 
inspection fee.
    Turning to the impact on State facilities, as of August 3, 1998, 
the SAC States in the three scenarios had within their borders 583; 
2,613; and 5,374 mammography facilities respectively. The analysis of 
the economic impact on these small entities was performed by comparing 
their savings arising from no longer paying the FDA inspection fee to 
their costs for the inspection support fees and the State costs.

                                                         Table 4.--Small Entity Economic Impact
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                SAC\1\ State Facility                                   Net Cost to Small         Net Savings to Small
                  Scenario                             Savings            SAC State Facility Costs           Entities                   Entities
--------------------------------------------------------------------------------------------------------------------------------------------------------
1                                                   $797,580                   $709,870                                               $87,710
2                                                 $3,651,401                 $3,650,563                                                  $838
3                                                 $7,489,128                 $8,180,723                  $691,595
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ SAC means States as certifiers.

    If the savings/cost is divided by the number of facilities in each 
scenario, it is found that, on the average, a facility in scenario 1 
would save about $150 per year, as compared to the present inspection 
fee. On the other hand, the average cost to a facility in scenario 3 
would increase about $129 per year. The average cost per facility in 
scenario 2 is essentially unchanged.
    The actual impact on an individual facility varies widely with the 
State. The extremes of this variation among the States in the analysis 
are illustrated by comparing the situation in the State with the 
highest inspection cost from among the 15 with the State with the 
lowest inspection cost. The facilities in the State with the lowest 
inspection cost would save, on the average, an estimated $200 per 
facility per year, over 10 percent of the FDA inspection fee, if their 
State became a SAC State. Facilities in the State with the highest 
inspection cost, however, would have to pay an average of about 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, showing how much 
the impact varies with the State. Even with an overall increase in the 
cost to the public as a whole and to the part of the public represented 
by the mammography facilities, some facilities will see savings.
    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. 
This interest was primarily based on a belief that by becoming a SAC 
State they could provide a service to the facilities and mammography 
patients within their borders. The service that they expect to be able 
to provide was an assurance of quality mammography at least equal to 
that under the national program but at a lower cost. The analyses above 
indicate that such a belief may be too optimistic in the case of the 
States whose inspection costs are significantly higher than the 
national average. If such States realize that this is indeed the case 
when they conduct their own analysis, it is unlikely that they will 
apply to become SAC States unless there are other benefits to 
compensate for the increased costs.
    Another encouraging factor is that there were still net savings to 
the small entities in scenario 1. Scenario 1, it should be remembered, 
is the scenario where the cost in the SAC States could be based upon 
the actual fees charged by the States in the Demonstration Project. It 
would be expected that this would lead to more accurate cost estimates 
than in scenarios 2 and 3 where a number of assumptions had to be 
substituted for actual experience. It is possible that these 
assumptions led to an overestimation of the costs and as other States 
enter the program they may be able to set their fees so as to 
adequately fund their activities but at a lower cost than in these 
estimates.
    The evaluations discussed above are based on evaluating the average 
impact on the mammography facilities in the non-SAC and SAC States. 
However, mammography facilities, even though

[[Page 16854]]

all are considered to be small entities, vary greatly in size and thus 
their ability to bear additional costs of complying with the MQSA 
requirements. To further evaluate the impact on small entities, 
facility compliance costs were compared with 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 following tables 5 and 6 present the average facility costs for 
facilities in both non-SAC and SAC States as a percentage of low volume 
facility revenues. For the non-SAC State facilities, the additional 
costs to the facilities through a worst case increase in the inspection 
fee (where all of the additional funds needed by FDA to fulfill its 
responsibilities for the MQSA inspection program must be raised by an 
increased inspection fee) is used for the comparison. It should be 
remembered that only the 82.4 percent of the non-SAC facilities 
inspected will see this impact. The 17.6 percent of these facilities 
that are not inspected in the year under consideration will pay no 
inspection fee and will not feel any impact from the increase. For the 
SAC State facilities, the average per facility cost in scenario 3 (as 
shown above, there would be a savings in scenarios 1 and 2) is compared 
to the facility revenues. These costs would be borne by all SAC State 
facilities.

        Table 5.--Cost/Savings Per Facility in Non-SAC\1\ States
------------------------------------------------------------------------
                                                       Inspection Fee
                                  Per Facility           Increase as
          Scenario                 Increase in          Percentage of
                                 Inspection Fee       Facility Revenue
------------------------------------------------------------------------
1                                    $16.52                  0.1%
2                                    $93.16                  1.0%
3                                   $160.23                  1.0%
------------------------------------------------------------------------
\1\ SAC means States as certifiers.


            Table 6.--Cost/Savings Per Facility in SAC States
------------------------------------------------------------------------
                                                             Cost as a
                 Net (Cost)/Savings to      Average per    Percentage of
   Scenario      SAC\1\ Small Entities     Facility Net      Facility
                                          (Cost) 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.

    The third aspect of the economic impact to be considered is the 
issue of 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 in any one 
year by State, local, and tribal governments, in the aggregate, or by 
the private sector, of $100 million. 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.
    Finally, in addition to the impact analyses discussed above, 
Executive Order 12866 requires agencies to select regulatory approaches 
that maximize net benefits while the Regulatory Flexibility Act 
requires agencies to analyze regulatory options that would minimize any 
significant impact of a rule on small entities. To fulfill these 
obligations, FDA considered and rejected the following three 
alternatives to the approach taken in the proposed rule: (1) Not 
implementing section 354(q) of the PHS Act; (2) recognizing existing 
State certification programs; and (3) implementing section 354(q) of 
the PHS Act through the issuance of more detailed regulations. The 
reasons for these rejections are discussed in detail in the regulatory 
impact study and cost analysis which is available at the Dockets 
Management Branch.
    In summary, this analysis shows that the economic impact on both 
the public and the small entities from the SAC program 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 as a whole was estimated to be less than 1 percent of the 
present cost of the MQSA activities that would be affected by the SAC 
program. The situation with respect to the component of the public 
represented by the 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 in scenario 
1 up to approximately 10 percent of the present fee in 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 in scenario 
1 to being about 8 percent greater in scenario 3. When the average cost 
for either SAC or non-SAC facilities in the various scenarios was 
compared to the revenues of a very small mammography facility, in no 
case did it exceed 1 percent of the facility revenues.
    Although the estimated average savings or increases for the 
facilities in both the non-SAC and SAC States vary with the scenario, 
they have in common the fact that they all represent small changes in 
the pre-SAC costs to the facilities from the inspection fee. However, 
it should be kept in mind that these averages camouflage much greater 
State by State variations in savings or added costs. As discussed 
above, FDA believes that a State is unlikely to apply

[[Page 16855]]

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 thus likely to experience a more 
favorable economic impact than that estimated in this analysis.
    FDA also believes that the expected benefits that will be achieved 
in guaranteeing quality mammography and reducing breast cancer 
mortality will be no less after these proposed regulations are 
implemented than before. Facilities in SAC States will have to meet 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 FDA-trained and equipped inspectors as would 
be the case if their State did not enter the SAC program. Because the 
benefits may actually increase, 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 assist mammography facilities 
seeking to improve the quality of their services or take enforcement 
actions against those relatively few facilities that present serious 
threats to the public health.
    Based upon these considerations, FDA has determined that this 
proposed rule is consistent with the principles set forth in the 
Executive Order, the Regulatory Flexibility Act, and the Unfunded 
Mandates Act. The economic impact on the public as a whole or on the 
portion of 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, an insignificant increase in costs may be 
experienced. However, because States are not likely to enter the 
program unless such entry will be of benefit to the facilities within 
their borders, a scenario leading to savings to the public as a whole 
and to the 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.

V. Executive Order 13132--Federalism

    On August 4, 1999, the President issued Executive Order 13132, 
Federalism, in which he set forth certain principles to be followed by 
Executive departments and agencies in developing policies that affect 
the division of governmental responsibilities between the Federal 
Government and the States. For the reasons discussed below, and, to 
some extent described in more detail above, FDA believes that this 
proposed rule is consistent with the principles embodied in Executive 
Order 13132.
    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 national standards, and, at the same time provides States 
that wish to become certification agencies with maximum flexibility in 
administering the program within their State.
    Also, as previously noted, interested States have had several 
opportunities to participate in the development of this policy through 
NMQAAC, the SAC Working Group, as accreditation bodies, and through the 
SAC Demonstration Project. States will have an additional opportunity 
to participate by submitting comments on this proposed rule.
    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 chose not to serve as certification agencies.
    If a State becomes a SAC State, the facilities within its borders 
will no longer pay Federal inspection fees nor will federally 
appropriated funds be used 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 the statute, for the 
inspection-related functions that the agency has retained. A State that 
becomes a certification agency will determine how the responsibilities 
that it has assumed will be funded. The funding could come from State 
appropriations or from a State fee assessed under either State or MQSA 
authority or some combination of these two sources.

VI. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review by OMB under the Paperwork Reduction Act of 1995 
(the PRA) (44 U.S.C. 3501-3520). A description of these provisions is 
given 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.
    FDA invites comments on: (1) Whether the proposed collection of 
information is necessary for the proper performance of FDA's functions, 
including whether the information will have practical utility; (2) the 
accuracy of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.
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 that they certify will meet minimum national standards for 
mammography quality. The certifying agency also must provide such 
information as is needed by the 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.

[[Page 16856]]



                  Table 7.--Proposed Requirements for States as Certifiers During Initial Year (Estimated Annual Reporting Burden) \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Annual
                21 CFR Section                     No. of       Frequency per   Total Annual      Hours per      Total Hours      Total Capital Costs
                                                 Respondents      Response        Responses       Response
--------------------------------------------------------------------------------------------------------------------------------------------------------
900.21(b)                                           13               1.0            13              50             650                   $130.00
900.21(c)(2)                                        13               1.0            13              25             475                    $65.00
900.22(i)                                            2.0             0.1             0.2             5               2.0                   $2.00
900.23                                               2.0             1.0             2.0            20              40.0                  $20.00
900.24(a)                                            2.0             0.05            0.1            10               1.0                   $2.00
900.24(b)                                            2.0             0.2             0.4            20               8.0                   $4.00
900.24(b)(2)                                         2.0             0.05            0.1            20               2.0                   $2.00
900.25(a)                                            2.0             0.25            0.5             5               2.5                   $5.00
Total                                                                                                            1,410.5                 $230.00
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.


  Table 8.--Proposed Requirements for States as Certifiers During Initial Year (Estimated Annual Recordkeeping
                                                   Burden) \1\
----------------------------------------------------------------------------------------------------------------
                                      Annual
 21 CFR Section       No. of       Frequency of    Total Annual      Hours per      Total Hours    Total Capital
                   Recordkeepers   Recordkeeping      Records      Recordkeeper                        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 (g)
900.25(b)               2.0             1.0             2.0             2.0             2.0            $5.00
Total                                                                                   6.0           $15.00
----------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.


    Table 9.--Proposed Requirements for States as Certifiers During Second and Later Years (Estimated Annual
                                              Reporting Burden) \1\
----------------------------------------------------------------------------------------------------------------
                                      Annual
 21 CFR Section       No. of       Frequency per   Total Annual      Hours per      Total Hours    Total Capital
                    Respondents      Response        Responses       Response                          Costs
----------------------------------------------------------------------------------------------------------------
900.22(i)              15.0             0.1             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           10               7.5            $7.50
900.24(b)              15.0             0.2             3.0            20              60.0           $30.00
900.24(b)(2)           15.0             0.05            0.75           20              15.0
900.25(a)              15.0             0.4             6.0             5              30.0           $60.00
Total                                                                                 420.0          $262.50
----------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.


    Table 10.--Proposed Requirements for States as Certifiers During Second and Later Years (Estimated Annual
                                            Recordkeeping Burden) \1\
----------------------------------------------------------------------------------------------------------------
                                      Annual
 21 CFR Section       No. of       Frequency per   Total Annual      Hours per      Total Hours    Total Capital
                   Recordkeepers   Recordkeeping      Records      Recordkeeper                        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 (g)
900.25(b)              15               1.0            15.0             1.0            15.0           $37.50
Total                                                                                  45            $112.50
----------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance 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 on the State 
Governments that choose to become certification agencies and not upon 
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 of the additional reporting and recordkeeping burden on 
the State Governments from these regulations is dependent upon 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, for 
purposes of estimation of the possible maximum

[[Page 16857]]

impact, it is assumed 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 new States added.
    A further complication is that the regulations will lead to two 
types of reporting and recordkeeping burdens. The first is the initial, 
one time burden resulting from applying for and obtaining approval as a 
State certification agency. The second is the ongoing burden arising 
from FDA fulfilling its oversight responsibilities. Because of the 
different nature and timeframes of these burdens, it is not possible to 
follow the usual practice of stating the burden on a single set of 
tables. For this reason, two sets of tables are provided. The first 
provides estimates of the burden during the first year of the program. 
During this year, it is assumed that the 13 new States will apply for 
and obtain approval as certification agencies and so during that year 
they will bear the initial one time burden associated with applying for 
and receiving approval as a SAC State under proposed Sec. 900.21. Iowa 
and Illinois, having already received approval during the Demonstration 
Project, will not have this burden. However, during the first year, 
they will have the ongoing burdens of the evaluation process (proposed 
Sec. 900.23) and possibly that associated with obtaining FDA approval 
for changes in previously approved standards (proposed Sec. 900.22(i)) 
and correcting deficiencies (proposed Secs. 900.24 through 900.25). The 
13 new States will not have been approved in time to have to face this 
ongoing burden during the first years. The second set of tables 
estimates the recordkeeping and reporting burden in succeeding years 
when all 15 States have only the ongoing burden.
    With respect to the ongoing burden, based upon the agency's 
experience with accreditation bodies, which must meet a similar 
requirement, it was estimated that a SAC State would seek approval for 
a change in previously approved standards once every 10 years. The 
annual frequency for reporting under proposed Sec. 900.22(i) thus would 
be 0.1. Each SAC State will be evaluated annually so the annual 
frequency for reporting under proposed Sec. 900.23 will be one. It was 
estimated that each State will have to respond to major deficiencies 
under proposed Sec. 900.24(a) only once every 20 years and minor 
deficiencies under proposed Sec. 900.24(b) only once every 5 years. The 
annual frequencies for reporting under those requirements were thus 
0.05 and 0.2 respectively. In the cases where there are minor 
deficiencies, it was assumed that the State will in most cases make the 
necessary corrections, but once every 20 years (in other words, once 
out of every four times it has minor deficiencies), the State would 
face possible withdrawal of approval under proposed Sec. 900.24(b)(2), 
so an annual of frequency of response of 0.05 was used there as well. 
Finally, it was assumed that once every 4 years (an annual frequency of 
0.25) each SAC State would seek an informal hearing under proposed 
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 (SOP's) in several areas. It was 
assumed that each State would spend an hour per year maintaining each 
SOP.
    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 
1,416.5 hours during the first year after the regulations were 
effective and an estimated additional burden of 465.0 hours in each 
succeeding year. Again, it should be remembered that the actual burden 
is dependent upon how many States voluntarily choose to enter the SAC 
program. These estimates are based up 15 States becoming SAC States. 
They would be reduced or increased if fewer 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 this proposed rule 
to OMB for review. Interested persons are requested to send comments 
regarding information collection by May 1, 2000 to the Office of 
Information and Regulatory Affairs, OMB, New Executive Office Bldg., 
725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: Wendy A. 
Taylor, Desk Officer for FDA.

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, it is 
proposed that 21 CFR parts 16 and 900 be amended as follows:

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

    1. The authority citation for 21 CFR part 16 is revised 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 adding in 
numerical order 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 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 by adding paragraphs (zz) and (aaa) to read as follows:


Sec. 900.2  Definitions.

    The following definitions apply to subparts A, B, and C of this 
part:
* * * * *
    (zz) Certification agency means a State that has been approved by 
FDA under Sec. 900.21 to certify mammography facilities.
    (aaa) Performance indicators means the measures used to evaluate 
the certification agency's ability to conduct certification, 
inspection, and compliance activities.
    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

[[Page 16858]]

Standards Act (MQSA) (42 U.S.C. 263b). Subpart C of this part 
establishes procedures whereby a State can apply to become an FDA-
approved certification agency to certify facilities 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 national quality 
standards established by FDA.


Sec. 900.21  Application for approval as a certification agency.

    (a) Eligibility. State agencies capable of meeting the requirements 
of this subpart may apply for approval as certification agencies.
    (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) 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 
their equivalence to FDA standards under Sec. 900.12;
    (iii) Detailed description of the applicant's review and decision 
making 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 fully certified 
mammography facilities will be inspected according to statutory 
requirements and procedures and policies for notifying facilities of 
inspection deficiencies;
    (L) Policies and procedures for enforcement of 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; and
    (O) 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 substantially the same as the quality standards published under 
subpart B of this part.
    (2) FDA will notify the applicant of any deficiencies in the 
application and request that those deficiencies be rectified within a 
specified time period. If the deficiencies are not rectified to FDA's 
satisfaction within the specified time period, the application for 
approval as a certification agency may be denied.
    (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 the MQSA.


Sec. 900.22  Standards for certification agencies.

    The certification agency shall accept the following 
responsibilities in order to ensure safe and accurate 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) of this section 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 equivalent to those of 
MQSA and this part 900.
    (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 accreditation or 
certification decisions.
    (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.
    (g) Patient notification. There shall be processes for the 
certification agency to conduct, or cause to be conducted, patient 
notifications should the State 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

[[Page 16859]]

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 standards that 
FDA has previously accepted under Sec. 900.21 or this section.


Sec. 900.23  Evaluation.

    FDA shall evaluate annually the performance of each certification 
agency. Such an evaluation shall include the use of performance 
indicators that address the adequacy of program performance in 
certification, inspection, and enforcement activities as well as 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 initiatives. The evaluation also shall include a 
review of any changes made 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 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 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, 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.
    (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 paragraph (a) of this section, including 
failure to follow its 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 
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) 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
    (2) 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: December 15, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-7653 Filed 3-29-00; 8:45 am]
BILLING CODE 4160-01-F