[Federal Register Volume 68, Number 171 (Thursday, September 4, 2003)]
[Notices]
[Pages 52589-52592]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-22477]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0376]


Medical Devices: 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 new 
fees the agency will assess for inspections of mammography facilities 
starting October 1, 2003. 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 the last increase on 
February 13, 1998, FDA is raising the fees accordingly. 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. This is only the second increase in inspection fees under 
the MQSA since the initial fee was established in 1995.

DATES: Effective October 1, 2003, for all inspections conducted under 
section 354(g) of the Public Health Service Act (PHS Act) (42 U.S.C. 
263b(g)). Submit written comments by October 1, 2003.

ADDRESSES: Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20857. Submit electronic comments 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: 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 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

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Secretary of Health and Human Services, as meeting quality standards 
(section 354(b) and (d)(iv) 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 1998. In 
addition, 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 October 1, 2003, 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, 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. Inspections will be 
conducted by inspectors who have met Federal training requirements and 
who are qualified 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 
section 354(g)(4) of the PHS Act).

III. Costs Included in the Fees to Be Assessed Beginning on October 1, 
2003

    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) 
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 on October 1, 2003. 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 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.

IV. Inspection Fees to be Assessed Beginning on October 1, 2003

    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, 2003. 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 $14.1 million in FY 2004. This is below the $16.4 
million authorized by Congress for collections in FY 2004. To recover 
the costs of the inspection program, the facility portion of the fee is 
$1,545 and each unit portion is $204. 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 $1,749 for a facility with one unit 
compares to the current fee of $1,549 for a facility with one unit.
    FDA will assess the following fees, beginning on October 1, 2003, 
for facility inspections, shown in table 1 of this document:

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           Table 1.--Annual Inspection Fee by Number of Units
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          Number of Units                            Fee
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1                                    $1,749
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2                                    $1,953
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3                                    $2,157
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4                                    $2,361
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5                                    $2,565
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6                                    $2,769
------------------------------------------------------------------------
7                                    $2,973
------------------------------------------------------------------------
Followup Inspection Fee              ...................................
                                     $991
------------------------------------------------------------------------

    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 certified 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 (www.cdc.gov/cancer/nbccedp) (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 Register) and at least 50 percent of the mammography screening 
examinations provided during the preceding 12 months were funded under 
that statute. Facilities providing mammography services using grants 
under other statutes will not qualify as a government entity. 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 follow-up), 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, Treasury Offset 
Program. 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.
    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

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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.

    Dated: August 26, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-22477 Filed 9-3-03; 8:45 am]
BILLING CODE 4160-01-S