On March 13, 2020, the Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) seeking to raise registration fees on all DEA registrants. The proposed fees represent a 21% increase over current fees for all registrant categories. DEA indicates that the increase will provide an additional $318 million for the Diversion Fee Account over the next three fiscal years.
As discussed here, the Controlled Substances Act requires that registration fees “shall be set at a level that ensures the recovery of the full costs of operating the various aspects of [the diversion control program].” 21 USC 886a(1)(C). DEA alleges in the NPRM that “[w]ithout an increase in registration fees, DEA will be unable to continue current operations” and will be unable to comply with the statutory mandate to recover all costs associated with managing the Diversion Control Program (DCP).
To support this doom and gloom prediction, DEA points to several reasons to justify the fee increase. They include, but are not limited to, the ongoing opioid crisis, the growing number of DEA registrants, a need for additional personnel at Headquarters and in Field Division Offices throughout the country, and additional requirements imposed by Congress in recent legislation.
In addition to raising fees, DEA also takes the opportunity to make one small but important change to its fee account. Currently, DEA’s policy is that it will not issue a refund of registration fees, including if the payment was made in error based on guidance provided by DEA personnel. The NPRM includes provisions that “will give DEA’s Administrator discretionary authority to refund registration fees.” The circumstances warranting consideration of a refund include: “applicant error, such as duplicate payments, payment for incorrect business activities, or payments made by persons who are exempt under this section from application or renewal fees; DEA error; and death of a registrant within the first year of the three-year registration cycle.”
As it has historically done, DEA selected a weighted-ratio method to assess the appropriate fee structure. This approach considers business activity, registrant population, projected budget for the DCP and other criteria in determining the fee for each registrant category. The following chart showing the new fee schedule is taken directly from the NPRM:
Comments on the NPRM must be submitted within 60 days of publication of the NPRM in the Federal Register.