The Drug Enforcement Administration (DEA) proposed a rule on Thursday that would amend regulations to require that DEA registration applications be submitted online. The rule would affect those applying for DEA registration for purposes of manufacturing, distributing, or administering controlled substances and certain chemicals.
According to the notice of proposed rulemaking, the purpose of a requirement to submit all initial and renewal registration applications through the DEA Diversion Control Division’s website is to “simplify the form submission process.” Under the rule, applicants will no longer be able to submit paper forms.
This rule would amend DEA regulations in seven sections. Among the amendments would be removing the option to submit paper forms, providing instructions for applying and paying online, clarifying payment options, clarifying the handling of defective applications, and removing any reference to the submission of paper forms by mail.
“Submission through the secure and online database will be a streamlined process which will benefit both DEA and registrants,” the proposal stated.
The rule comes after an observed decrease in submission of paper forms from 2016 to 2020: paper applications, as a percentage of total applications, made up 7.5% in 2016, 2.8% in 2017, 1.5% in 2018, and 1.1% in 2019, and “(i)n the first three months of 2020, 99.3 percent of all DEA registration forms were submitted electronically via DEA’s secure website and 0.7 percent were submitted by paper,” according to the proposal.
The DEA said the rule will make the registration submission process more cost effective due to eliminating printing and postage and production costs, such as paper forms, envelopes, and labor, and, given “(m)any paper submissions contain illegible or erroneous information or omit required information,” eliminate the “time-consuming process” of the DEA contacting applicants to provide corrections, as validation features are built into the online system. Online submissions also “will ensure the Administration’s receipt of applications in a more timely and organized manner,” as noted in the proposed rulemaking.
The DEA is accepting comments on the proposed rule until 11:59 p.m. Eastern Standard Time on March 8, 2021.
