[Federal Register Volume 63, Number 9 (Wednesday, January 14, 1998)]
[Notices]
[Pages 2245-2248]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-881]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94N-0335]
Medical Devices; Mammography Quality Standards Act of 1992;
Inspection Fees
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the new
fees the agency will assess for inspections of mammography facilities
starting on February 13, 1998. The Mammography Quality Standards Act of
1992 (the MQSA) requires FDA to assess and collect fees from
mammography facilities to cover the costs of annual inspections
required by the MQSA. Because these costs have increased since
inspections began in 1995, FDA is raising the fees accordingly. This
notice explains which facilities are subject to payment of inspection
fees, provides information on the costs included in developing
inspection fees, and provides information on the inspection, billing,
and collection processes. This is the first increase in inspection fees
under the MQSA since the initial fee was established in 1995.
[[Page 2246]]
DATES: Effective February 13, 1998, for all inspections conducted under
42 U.S.C. 263b(g). Submit written comments by March 16, 1998.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-123,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: John L. McCrohan, 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 amended Title III of the Public Health Services Act (the
PHS Act) (42 U.S.C. 262 et seq.) by adding a new section 354 (42 U.S.C.
263b) to require uniform national quality standards for mammography
facilities. The MQSA requires all mammography facilities, other than
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 as meeting quality standards. The MQSA requires FDA
to establish and operate: (1) A Federal certification and inspection
program for mammography facilities, (2) regulations and standards for
accreditation bodies, and (3) standards for equipment, personnel,
quality assurance, and recordkeeping and reporting by mammography
facilities.
The MQSA requires annual facility inspections to determine
compliance with the quality standards. Section 354(r) of the PHS Act
requires FDA to assess and collect fees for inspections of all
mammography facilities, other than governmental entities as determined
by FDA, to cover the costs of inspections. The original notice on the
MQSA fees was published in the Federal Register of March 17, 1995 (60
FR 14584), and was effective with the initiation of the inspection
program in January 1995. An updated resource review has demonstrated
that the recoverable costs of the MQSA inspection program have
increased since 1995, and that the annual amount of fees collected
under the current fee schedule has been well below the level authorized
by Congress. Accordingly, the fees have been recalculated so that the
aggregate amount of fees collected will equal the aggregate costs of
the inspections conducted, as mandated by the MQSA.
Therefore, FDA is providing notice of the increased fees to be
assessed starting on February 13, 1998, and additional information
relating to those fees. Although the MQSA does not require FDA to
solicit comments on fee assessment and collection, FDA is inviting
comments from interested persons in order to have the benefit of
additional views and information, as the agency continues to evaluate
its fee assessment procedures.
II. Inspections Under the Mammography Quality Standards Act of 1992
Section 354 (g)(1) of the PHS Act requires FDA, or a State
operating under a delegation of authority from FDA, to conduct an
annual inspection of each mammography facility. The purpose of the
annual inspection is to determine facility compliance with quality
standards established under the MQSA final quality standards were
recently published in the Federal Register on October 28, 1997 (62 FR
55852). Inspections will be conducted by inspectors who have met
Federal training requirements and who are certified by FDA.
Under ordinary circumstances, inspections will be conducted during
the regular business hours of the facility or at a mutually agreed
time. FDA normally will provide 5 working days advance notice of each
annual inspection. If a significant deficiency is identified during an
inspection, FDA will provide information on necessary corrective action
and, in appropriate cases, will schedule a followup inspection after
the facility has had a reasonable time to correct the deficiency. FDA
normally will provide 5 working days advance notice of each followup
inspection. FDA may make unannounced inspections or may provide shorter
notice if prompt action is necessary to protect the public health (see
42 U.S.C. 263b(g)(4)).
III. Costs Included in 1998 Inspection Fee
Section 354(r) of the PHS Act requires FDA to assess and collect
fees from persons who own or lease mammography facilities, or their
agents, to cover the cost of annual and followup inspections conducted
by FDA or a State acting under a delegation from FDA. Section 354(r)
limits FDA's discretion in setting inspection fees in three ways: (1)
Fees must be set so that, for a given fiscal year (FY), the aggregate
amount of fees collected will equal the aggregate costs of inspections
conducted; (2) a facility's liability for fees must be reasonably based
on the proportion of the inspection costs that relate to the facility;
and (3) governmental entities, as determined by FDA, are exempt from
payment of fees.
FDA has determined that the following categories of costs are
recoverable under section 354(r) of the PHS Act and has included them
in the fees to be assessed beginning February 13, 1998. These
categories represent the same costs that have been assessed in fees
since the beginning of the inspection program. Facilities are not being
assessed for any new costs associated with inspections.
Personnel costs of annual and followup inspections of
mammography facilities, including administration and support.
Purchase of equipment, development of instrument
calibration procedures, calibration of instruments used in the
inspections, and modification of training facilities and laboratories
to support the MQSA operations.
Design, programming, and maintenance of data systems
necessary to schedule and track inspections and to collect data during
inspections.
Training and certification of inspectors (both FDA and
State inspectors).
Costs of billing facilities for fees due for annual and
followup inspections and collecting facility payments.
Tracking, coordination, and direction of inspections.
Overhead and support attributable to facility inspections.
Because most scientific equipment is durable and can be used for a
period of years, it is not appropriate to recover the full costs of
such expenditures in the year of purchase. To do so would result in the
MQSA inspection fee varying widely from one year to the next. Instead,
these costs will be recovered over the useful life of the asset. FDA
has not and will not recover compliance costs (e.g. taking legal and
administrative enforcement actions) in the fee.
The recoverable portions of all fixed costs of the inspection
program and appropriate variable costs are recovered in the annual
inspection fee. This fee will vary depending on how many mammography
units are used by a facility. All mammography facilities, except
governmental entities, will be subject to this fee.
If the annual inspection of a facility identifies a deficiency that
necessitates a followup inspection, that facility will be assessed an
additional fee to recover the costs of that additional inspection
(unless it is a governmental entity). Facilities that do not require a
followup inspection are not subject to this fee.
[[Page 2247]]
IV. Inspection Fees to be Assessed Starting February 13, 1998
The costs of the MQSA inspection program have grown since its
startup year, while the inspection fee has been held constant since its
inception in FY95. Beyond the inflationary increases that are to be
expected over the course of 3 years, the increased costs in the
inspection program are attributable to two major areas: The actual rate
of inspections and the full-scale implementation costs of the data
systems. These costs account for the major difference between the costs
of the startup phase of the program in FY95 and the full-scale
operation in FY98, and they are largely responsible for the fee
increase.
Although state inspectors, under contract with FDA, technically
began inspections in January 1995, the first round of inspections
actually extended well into FY96, when the bulk of the inspector cadre
was hired and trained. Thus, the FY98 costs of the inspection program
are almost $4 million higher than the FY95 costs, because roughly
10,000 facilities will be inspected in FY98, more than twice as many as
the 4,900 inspections conducted in FY95. In addition, FY98 costs
reflect the full-scale oversight and scientific support necessary to
manage a national inspection program that now utilizes 250 inspectors
to inspect 10,000 facilities annually. Between FY95 and FY98, the State
contracts and associated costs have grown 64 percent and this State
activity accounts for 72 percent of the total FY98 inspection program
budget.
The data systems component of the inspection program has increased
by almost $800,000 over FY95 levels, and it accounts for 8 percent of
the total FY98 inspection program budget. The development,
implementation, and support of this integrated system required
increased investment in data systems over the FY95 levels. In FY95,
only the rudimentary components of the system were operational. The
data system is now in the final stages of development and
implementation. It includes the inspector laptop with customized
inspection software and a communications system that integrates the
field and headquarters components of the inspection program. The
overall system enables electronic communication between the inspector
and headquarters for communicating inspection results, initiating and
tracking inspection followup, and conducting ongoing inspector/
headquarters education regarding the inspection program.
The remaining 20 percent of the FY98 inspection program budget
covers training, equipment calibration, inspection administration,
billing, and the fee assessment.
FDA reviewed the past methodology for calculating the inspection
fee, which accounted for differences in facility size. A similar method
was adopted for calculating the 1998 fee. A facility's inspection fee
will be based on the number of mammography units used by the facility.
FDA data on inspected facilities indicates that there are roughly
10,112 total mammography facilities and approximately 12,720
mammography units. The number of mammography facilities identified as
Government entities is around ten percent.
The total recoverable aggregate costs of the MQSA inspection
program is estimated to be $12.8 million in FY 1998. This is below the
$14 million authorized by Congress for collections in FY 1998. To
recover the costs of the inspection program, the facility portion of
the fee is $1,345 and the unit portion is $204, and these must be added
according to the number of units at each facility. This new fee of
$1,549 for a facility with one unit compares to the current fee of
$1,178 for a facility with one unit.
The following fees will be assessed starting February 13, 1998, for
facility inspections conducted after that date:
Table 1.--Annual Inspection Fee by Number of Units
------------------------------------------------------------------------
Number of Units Fee
------------------------------------------------------------------------
1................................... $1,549
2................................... $1,753
3................................... $1,957
4................................... $2,161
5................................... $2,365
6................................... $2,569
7................................... $2,773
------------------------------------------------------------------------
Followup Inspection Fee...............................................
------------------------------------------------------------------------
Fee................................. $878
------------------------------------------------------------------------
FDA will continue to charge separately for annual and followup
inspections. FDA believes it is more appropriate and equitable for the
costs of followup inspections to be borne entirely by the facilities
that require such inspections. FDA has again chosen to adopt a flat fee
for followup inspections over an hourly rate that would vary the fee by
the length of the inspection. This approach eliminates concerns about
variations among inspectors and differential treatment of facilities.
The fee schedule is subject to change each year to ensure that the
aggregate amount of fees collected during any year equals the aggregate
amount of costs for that year's facility inspections. FDA notes,
however, that the initial fees established in FY 1995 remained constant
for a period of 3 years. The agency expects this new fee schedule to
remain constant through FY 1999. FDA will monitor the adequacy of the
fee on an annual basis.
FDA continues to use a uniform, national fee structure. The
methodology adopted by FDA to determine inspection fees does not pass
on the costs of inspecting governmental entities to other facilities.
The entire cost of inspecting governmental entities has been and will
continue to be borne by appropriated funds.
V. Facilities Subject to Payment of Inspection Fees
Under the MQSA, all certified mammography facilities except
governmental entities, as determined by FDA, are subject to payment of
inspection fees (see 42 U.S.C. 263b(r)).
FDA will continue to use the definition that was previously
developed and applied to determine whether a facility qualifies as a
governmental entity for the purpose of
[[Page 2248]]
determining whether a facility is exempt from payment of inspection
fees under 42 U.S.C. 263b(r). A governmental entity is a mammography
facility subject to inspection under section 354(g)(1) of the PHS Act
(42 U.S.C. 263b(g)(1)), that meets either of the following criteria:
(1) Is operated by any Federal department, State, district, territory,
possession, Federally-recognized Indian tribe, city, county, town,
village, municipal corporation or similar political organization or
subpart thereof; or (2) provides services under the Breast and Cervical
Cancer Mortality Prevention Act of 1990, 42 U.S.C. 300k et. eq., and at
least 50 percent of the mammography screening examinations provided
during the preceding 12 months were funded under that statute. The
first notice of fees for facilities provides additional background
relating to this definition (see 52 FR 14585).
VI. Billing and Collection Procedures
Within 30 days following inspection, FDA mails a bill to the
inspected facility (governmental entities do not receive bills). The
bill sets forth the type of inspection conducted (annual or followup),
the fee to be paid, and the date payment is due (30 days after billing
date). Inspection fees are billed to and collected from the party that
operates the facility. If the facility is owned or controlled by an
entity other than the operator, it is up to the parties to establish,
through contract or otherwise, how the costs of facility inspections
will be allocated.
If full payment is not received by the due date, a second bill is
sent. At that time, interest begins to accrue at the prevailing rate
set by the Department of the Treasury (currently, the prevailing rate
is 13.75 percent), a 6 percent late payment penalty is assessed in
accordance with 45 CFR 30.13, and a $20 administrative fee is assessed
for each 30-day period that a balance remains due. If payment is not
received within 30 days of a third and final bill, FDA may initiate
action to collect unpaid balances (with interest and penalties),
including the use of collection agencies and reporting of delinquencies
to commercial credit reporting agencies.
Any questions or concerns about the billing and collection
procedures may be addressed to Billing Inquiries c/o Mammography
Quality Assurance Program, FA, P.O. Box 6057, Columbia, MD 21045-6057,
1-800-838-7715.
VII. Review and Appeals Procedures Regarding Qualifications as a
Governmental Entity
FDA will review each declaration that a facility qualifies as a
governmental entity. If FDA disallows a facility's claim that it is a
governmental entity, a bill will be sent to the facility with payment
due within 30 days.
If FDA determines that a facility is not a governmental entity, but
the facility believes it qualifies for exemption under the definition
of governmental entity set forth previously, the facility may appeal
FDA's determination by explaining and certifying the basis for its
belief in a letter directed to the FDA Ombudsman c/o Mammography
Quality Assurance Program, FA, P.O. Box 6057, Columbia, MD 21045-6057,
postmarked within 30 days of FDA's notice to the facility that the
facility does not qualify as a governmental entity. The FDA Ombudsman
will review a facility's claim that it is a governmental entity and
will normally reach a decision within 60 days. If the Ombudsman
determines that a facility does not qualify as a governmental entity,
the Ombudsman shall provide a statement of the grounds for that
determination. The Ombudsman's decision will constitute the agency's
final decision on the matter. During the time required for the
Ombudsman's review, FDA's efforts to collect the fee will be suspended
and all time-related penalties held in abeyance.
VIII. Request for Comments
Although the MQSA does not require FDA to solicit comments on fee
exemption, assessment and collection, FDA is inviting comments from
interested persons in order to have the benefit of additional views.
FDA may consider altering its methodology of defining governmental
entities, and assessing and collecting fees under the MQSA in future
years. Each year's inspection experience provides additional data about
differences among facilities and variations in costs by State, region,
or other factors.
Interested persons may, on or before March 16, 1998, submit to the
Dockets Management Branch (address above) written comments regarding
this notice. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments and a full explanation of the costs
included and the methodology employed in determining these fees are on
file with the Dockets Management Branch (address above) and may be seen
in that office between 9 a.m. and 4 p.m., Monday through Friday.
Dated: December 23, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-881 1-13-98; 8:45 am]
BILLING CODE 4160-01-F
