Department of Health and Human Services 

Substance Abuse and Mental Health Services Administration

Center for Substance Abuse Prevention

National Laboratory Certification Program (NLCP)

HHS-Certified Laboratory and Instrumented Initial Testing Facility Notice

Date: August 29, 2019

Subject: Fee Schedule

This notice provides the new fee schedule for laboratories and instrumented initial 

testing facilities (IITFs) participating in or applying for certification in the Department of 

Health and Human Services’ (HHS) National Laboratory Certification Program (NLCP). 

The new fee schedule is effective October 1, 2019.

The NLCP is a self-supporting program and each participant test facility (i.e., laboratory 

or IITF) is required to pay fees. To maintain the program, the Substance Abuse and 

Mental Health Services Administration (SAMHSA) Division of Workplace Programs 

(DWP) periodically reviews all costs associated with the inspection and performance 

testing (PT) programs. Every effort is made to ensure that the NLCP is a self-supporting 

program and that each test facility pays fees commensurate with the costs of each part 

of the program.

The following summarizes the changes that are to be effective on October 1, 2019:

1. RTI has added a new laboratory category, Category 7. Since SAMHSA 

established Categories 0 through 6, the workloads of some certified laboratories 

have increased such that the current inspection format is not sufficient to enable 

review of the target percentage (i.e., about 10%) of the laboratory’s non-negative 

specimens. Laboratories will continue to be notified of their category changes. 

We are not making changes to other NLCP fees. However, the following describes 

additional changes to some NLCP inspections/audits: 

2. Increase the number of audited non-negative specimens for laboratories in 

Categories 1, 4, 5 (inspections), and 6 (inspection and audit). The addition of four 

prescription opioids to the regulated drug testing panel was effective Oct. 1, 2017 

for federal specimens and Jan. 1, 2018 for Department of Transportation regulated 

specimens. The added drugs led to increased numbers of non-negative specimens 

which, in turn, reduced the percent audited to less than the program’s 10% target. 

Current inspection resources should enable review of additional specimens in 

these categories without increasing fees. With these changes, the percentage 

audited remains below, but closer to, the 10% target in these laboratories.

3. Add to criteria for changing Category 0 inspections to Category 1. Category 0 was 

established to reduce fees for very small laboratories in the NLCP with 1.5-day 

inspections. When additional inspection resources are required, the inspections for 

Category 0 laboratories are extended to 2 days and the laboratory is charged a 

Category 1 inspection fee. Current criteria are: when the inspection includes a 

Responsible Person (RP)/Alternate RP interview; when the laboratory’s previous 
inspection was unacceptable; when a major PT error was incurred/remediated 

since the previous inspection; and when the laboratory is in the process of 

mergers, acquisitions, moves within a facility, or relocation. RTI is adding two 

additional criteria: when the laboratory has validated more than one assay or new 

instrument model since the previous inspection; and when the laboratory has 

remediated multiple errors during the last two NLCP PT cycles. 

If you have any questions regarding these changes, please contact me at (240)

276-2600 or by email: Ron.Flegel@samhsa.hhs.gov.

Ron Flegel 

Director

Division of Workplace Programs

 Ron Flegel
The NLCP Fee Schedule, effective October 1, 2019 is as follows for 

Laboratories and Instrumented Initial Testing Facilities:

Event Fee ($)

Application $3,000 

Inspections

Initial $12,900 

3-month Second Initial $12,900 

Maintenance

IITF $12,900 

Laboratory:

Category 0 $10,400 

Category 1 $12,900 

Category 2 $18,800 

Category 3 $28,500 

Category 4 $43,700 

Category 5 - Inspection $43,700 

Category 5- Audit $28,500 

Category 6 - Inspection $54,600 

Category 6- Audit $39,400 

Category 7 - Inspection $65,500

Category 7- Audit $50,300

Special Inspection Actual cost

Remedial Action

Pre-inspection $1,000 

Post-inspection $3,000 

Performance Testing

Initial Set $3,000 

Maintenance Set $3,000 

Remedial Action

Major $3,000 

Reoccurring Minor $1,000 

Withdrawal - Final Inspection/Audit Actual Cost

The fee schedule will continue to be evaluated periodically to ensure fees accurately 

reflect the costs associated with each activity.