[Code of Federal Regulations]
[Title 42, Volume 3]
[Revised as of October 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR493.649]

[Page 988-989]
 
                         TITLE 42--PUBLIC HEALTH
 
  CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 
                 HEALTH AND HUMAN SERVICES--(Continued)
 
PART 493--LABORATORY REQUIREMENTS--Table of Contents
 
                    Subpart F--General Administration
 
Sec. 493.649  Methodology for determining fee amount.

    (a) General rule. The amount of the fee in each schedule for 
compliance determination inspections is based on the average hourly rate 
(which includes

[[Page 989]]

the costs to perform the required activities and necessary 
administration costs) multiplied by the average number of hours required 
or, if activities are performed by more than one of the entities listed 
in paragraph (b) of this section, the sum of the products of the 
applicable hourly rates multiplied by the average number of hours 
required by the entity to perform the activity. The fee for issuance of 
the registration certificate or certificate of compliance is based on 
the laboratory's scope and volume of testing.
    (b) Determining average hourly rates used in fee schedules. Three 
different entities perform activities related to the issuance or 
reissuance of any certificate. HHS determines the average hourly rates 
for the activities of each of these entities.
    (1) State survey agencies. The following costs are included in 
determining an average hourly rate for the activities performed by State 
survey agencies:
    (i) The costs incurred by the State survey agencies in evaluating 
personnel qualifications and monitoring each laboratory's participation 
in an approved proficiency testing program. The cost of onsite 
inspections and monitoring activities is the hourly rate derived as a 
result of an annual budget negotiation process with each State. The 
hourly rate encompasses salary costs (as determined by each State's 
civil service pay scale) and fringe benefit costs to support the 
required number of State inspectors, management and direct support 
staff.
    (ii) Travel costs necessary to comply with each State's 
administrative requirements and other direct costs such as equipment, 
printing, and supplies. These costs are established based on historical 
State requirements.
    (iii) Indirect costs as negotiated by HHS.
    (2) Federal agencies. The hourly rate for activities performed by 
Federal agencies is the most recent average hourly cost to HHS to staff 
and support a full time equivalent employee. Included in this cost are 
salary and fringe benefit costs, necessary administrative costs, such as 
printing, training, postage, express mail, supplies, equipment, computer 
system and building service charges associated with support services 
provided by organizational components such as a computer center, and any 
other oversight activities necessary to support the program.
    (3) HHS contractors. The hourly rate for activities performed by HHS 
contractors is the average hourly rate established for contractor 
assistance based on an independent government cost estimate for the 
required workload. This rate includes the cost of contractor support to 
provide proficiency testing programs to laboratories that do not 
participate in an approved proficiency testing program, provide 
specialized assistance in the evaluation of laboratory performance in an 
approved proficiency testing program, perform assessments of cytology 
testing laboratories, conduct special studies, bill and collect fees, 
issue certificates, establish accounting, monitoring and reporting 
systems, and assist with necessary surveyor training.
    (c) Determining number of hours. The average number of hours used to 
determine the overall fee in each schedule is HHS's estimate, based on 
historical experience, of the average time needed by each entity to 
perform the activities for which it is responsible.

[57 FR 7138 and 7213, Feb. 28, 1992, as amended at 60 FR 20048, Apr. 24, 
1995]

Subpart G [Reserved]