[Federal Register: July 6, 2007 (Volume 72, Number 129)]
[Notices]
[Page 37027-37029]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06jy07-75]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0238]
Medical Devices: The Mammography Quality Standards Act of 1992
and Subsequent Mammography Quality Standards Reauthorization Act and
Amendments; Inspection Fees
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
increased fees the agency will assess for inspections of mammography
facilities starting October 1, 2007. 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, FDA is
raising the fees to ensure the program is able to meet its objective of
ensuring that high quality mammography remains available to women. This
document 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.
DATES: Effective October 1, 2007, for all inspections conducted under
section 354(g) of the Public Health Service Act (PHS Act) (42 U.S.C.
263b(g)). Submit written or electronic comments by October 1, 2007.
ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Helen J. Barr, Center for Devices and
Radiological Health (HFZ-240), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850, 240-276-3332, FAX: 240-276-3272.
SUPPLEMENTARY INFORMATION:
I. Background
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 (section 354(b) and (d) of the
PHS Act). The MQSA requires FDA to establish and operate the following:
(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 (section 354(c),
(e), (f), and (g) of the PHS Act). The MQSA requires annual facility
inspections to determine compliance with the quality standards (section
354(g) of the PHS Act). Section 354(r) of the PHS Act requires FDA to
assess and collect fees for inspections of mammography facilities,
other than governmental entities as determined by FDA, to cover the
costs of inspections.
An updated resource review has demonstrated that the recoverable
costs of the MQSA inspection program have increased since the last
notice on fees in 2003 (68 FR 5289, September 4, 2003). In addition,
the annual amount of fees collected under the current fee schedule has
been well below the level authorized by Congress. FDA needs to be able
to collect the full cost of mammography inspections to ensure it has
the resources to ensure high quality mammography remains available to
women. Accordingly, the fees have been recalculated so that the
aggregate amount of fees collected will equal the aggregate recoverable
costs of the inspections conducted, as mandated by the MQSA. Therefore,
FDA is providing notice of the increased fees to be assessed starting
on October 1, 2007, and additional information relating to those fees.
II. Inspections Under the Mammography Quality Standards Act of 1992
Section 354(g)(1) of the PHS Act requires FDA, States as Certifier
(SAC) States, or a State or local agency acting on behalf of the 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. Inspectors who have
met Federal training requirements and who are qualified by FDA will
conduct inspections.
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
section 354(g)(4) of the PHS Act).
III. Costs Included in the Fees to Be Assessed Beginning on October 1,
2007
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 costs of inspections conducted by FDA, SAC States,
or a State or local agency acting on behalf of FDA. Section 354(r) of
the PHS Act 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
[[Page 37028]]
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 on October 1, 2007. 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.
Cost categories are as follows: (1) Personnel costs of annual and
followup inspections of mammography facilities, including
administration and support; (2) purchase of equipment, calibration of
instruments used in the inspections, and modification and maintenance
of training facilities and laboratories to support the MQSA operations;
(3) design, programming, and maintenance of data systems necessary to
schedule and track inspections and to collect data during inspections;
(4) training and qualification of inspectors (both FDA and State
inspectors); (5) costs of billing facilities for fees due for annual
and followup inspections and collecting facility payments; (6)
tracking, coordination, and direction of inspections; and (7) overhead
and support attributable to facility inspections.
Because most equipment used for inspections 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, FDA recovers these costs over the useful life of the
asset.
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, are subject to an inspection fee. If the annual
inspection of a facility identifies a deficiency that necessitates a
followup inspection, the 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.
IV. Inspection Fees to be Assessed Beginning on October 1, 2007
FDA reviewed the past methodologies for calculating the inspection
fee, which accounted for differences in facility size. The same method
was adopted for calculating the fees FDA will assess beginning on
October 1, 2007 (Ref. 1). A facility's inspection fee will be based on
the number of mammography units used by the facility.
The total recoverable aggregate cost of the MQSA inspection program
is estimated to be $15.77 million in FY 2008. This is below the $16.4
million authorized by Congress for collections in FY 2004, the last
time fees were increased, and well below the $18.4 million authority
requested from Congress for MQSA user fee collections in FY 2008. To
recover the costs of the inspection program, the facility portion of
the fee is $1,900 and each unit portion is $250. The cost of each
additional unit must be added to the facility portion of the fee to
determine the total inspection fee. This new fee of $2,150 for a
facility with one unit replaces the current fee of $1,749 for a
facility with one unit.
FDA will assess the following fees, beginning on October 1, 2007,
for facility inspections, as shown in table 1 of this document:
Table 1.--Annual Inspection Fee by Number of Units
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Number of Units Fee
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1 $2,150
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2 $2,400
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3 $2,650
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4 $2,900
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5 $3,150
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6 $3,400
------------------------------------------------------------------------
7 $3,650
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8 $3,900
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9 $4,150
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10 $4,400
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Followup Inspection Fee $1,144
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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 will monitor
the adequacy of the fee on an annual basis to account for any major
programmatic and budget changes.
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 mammography facilities, except governmental
entities as determined by FDA, are subject to payment of inspection
fees (see section 354(r) of the PHS Act). 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 determining whether a facility is exempt from payment of inspection
fees under section 354(r) of the PHS Act. A facility may qualify as a
governmental entity in two ways. First, a facility may qualify if any
Federal department, State, district, territory, possession, Federally-
recognized Indian tribe, city, county, town, village, municipal
corporation, or similar political organization does the following: (1)
Operates the facility; (2) pays the entire salary of all onsite
personnel for the facility; (3) owns, rents, or leases all of the
facility's mammography equipment; and (4) has the ultimate authority to
make day-to-day decisions concerning the management and operation of
the facility.
Second, a facility may qualify as a governmental entity if the
facility provides services under the Breast and Cervical Cancer
Mortality Prevention Act of 1990, (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://apps.nccd.cdc.gov/cancercontacts/nbccedp/contacts.asp
) and at least 50 percent of the
mammography screening examinations provided during the preceding 12
months were funded under that statute. (FDA has verified the Web site
address, but FDA is not responsible for any subsequent changes to the
Web site after this document publishes in the Federal
[[Page 37029]]
Register.) Facilities providing mammography services using grants under
other statutes will not qualify as government entities. FDA does not
recognize, as a governmental entity, a facility providing Medicare/
Medicaid services unless that facility qualifies as a governmental
entity as described in the previous paragraph.
VI. Billing and Collection Procedures
Within 30 days following inspection, FDA mails a bill and a
``Governmental Entity Declaration'' form (Form 3422) to the inspected
facility. Facilities who believe they meet the governmental entity
criteria complete the form and return it in lieu of the inspection fee
payment. 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, 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, the reporting of
delinquencies to commercial credit reporting agencies, and forwarding
delinquent accounts to the Department of the Treasury. Any questions or
concerns about the billing and collection procedures may be addressed
to Billing Inquiries c/o Mammography Quality Assurance Program, P.O.
Box 6057, Columbia, MD 21045, 1-800-838-7715.
VII. 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 and
information, as the agency continues to evaluate its fee assessment
procedures.
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
VIII. References
The following reference is on display in the Division of Dockets
Management (see ADDRESSES) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. U.S. Food and Drug Administration, MQSA Inspection Fees:
Methodology and Fees for Fiscal Year 2008.
Dated: June 27, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-13044 Filed 7-5-07; 8:45 am]
BILLING CODE 4160-01-S