[Code of Federal Regulations]

[Title 42, Volume 4]

[Revised as of October 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR493.649]



[Page 1009-1010]

 

                         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 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



[[Page 1010]]



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]