of electronic CCFs for DOT-mandated drug and alcohol testing programs. To ensure that the DOT regulations con-
form to SAMHSA’s approved chain of custody and control procedures, the DOT is issuing this final rule to expand the current definition of the CCF in 49 CFR 40.3 to include all ver- sions of the CCF as approved by OMB. Tey are amending §40.45 to explain that the 5-part form can be a paper form or an approved elec- tronic form, as long as the employer ensures that security and confidentiality concerns are addressed. Te DOT is amending §40.73 to require entities using an eCCF to follow the eCCF procedures approved by SAMHSA through the NLCP inspection process. While approved for use, it is important
to note that an eCCF is not usable until the laboratory has gone through the approval process for the eCCF. Currently there
are no laboratories with eCCF approval, however, DATIA will keep its members informed as approvals are issued. Te eCCF requires the same collec-
tion of information and distribution of information to the relevant parties as the paper CCF requires. With the approved eCCF, HHS is not requiring collection of any new or different information. Te only change from the paper CCF to the eCCF is the mechanism for collecting and trans- miting the requisite information. Before implementing an eCCF, HHS-certified laboratories must provide a detailed plan and proposed standard operating pro- cedures (SOPs) for SAMHSA to review and approve through SAMHSA’s Na- tional Laboratory Certification Program (NLCP). Te review of validation records, specimen records, SOPs, staff training
records, and practices associated with the eCCF will be part of the NLCP inspection process. Once the eCCF is approved for use through the NLCP inspection process, it may be used in the DOT drug testing program, as well as the Federal Workplace Drug Testing Program. For more informa- tion regarding this approval process, please contact the Department of Health and Hu- man Services, Substance Abuse and Mental Health Services Administration, Division of Workplace Programs, National Laboratory Certification Program at (919) 541–7242, or via email at
nlcp@rti.org. It is important to note that electronic
signatures are not otherwise acceptable in Part 40. Te use of the eCCF will create an exception so that electronic signatures will be acceptable on these forms only and not throughout the rest of Part 40. ❚
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Paula D. Layton 110 Dixie Street Carrollton, GA 800-356-9804
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