CCF No Material or Nonsubstantive Change Justification

Substance Abuse and Mental Health Services Administration

2020 Federal Drug Testing Custody and Control Form

No Material or Nonsubstantive Change Justification

The Substance Abuse and Mental Health Services Administration (SAMHSA) is requesting a no material or nonsubstantive change approval from the Office of Management and Budget (OMB) for (OMB No. 0930-0158) 2020 Federal Drug Testing Custody and Control Form (CCF).

It has been brought to HHS’s attention there is a shortage of raw materials needed for the Federal CCF, apparently due to the materials’ use for COVID-related activities. Short supplies include the carbonless paper used for CCF and the resins and plastics used for the labels directly affixed to the form. Items used for specimen collection kits (e.g., cardboard, shipping materials) are also in short supply. The shortages were reported to HHS by the Department of Transportation (DOT) and HHS-certified laboratories. Additionally, it was noted there is only one supplier of this carbonless paper and the supplier has indicated they will not be increasing its production. When the 2020 Federal CCF was approved, OMB extended the expiration date of the previous form (2017 Federal CCF) from August 31, 2020 to August 31, 2021. Formally allowing the use of the previous form would negate the need for memoranda for the record (MFR) to be included with each specimen collected on the 2017 Federal CCF expired form, as is currently required.

SAMHSA is requesting approval to change the terms and to allow the use of the 2017 expired Federal CCF until the supply chain is fully functional. This change would reduce laboratory burden, accommodate DOT’s collection process, and, in addition preserve the supply use by the non-regulated sector, which uses the same materials as the federally regulated sector.