On July 29, 2020, DEA published a Notice of Proposed Rulemaking titled, “Reporting of Thefts or Significant Loss of Controlled Substances.” (85 Fed. Reg. 45547 (Jul. 29, 2020)). See Federal Register notice here. As registrants are well aware, the current DEA regulation addressing reporting to DEA of thefts and significant losses of controlled substances requires applicable registrants to submit in writing an “initial notification” of a theft or significant loss to the Field Division Office of Administration in his or her area, within one business day of discovery. Next, the registrant must complete, and submit to the Field Division Office in his or her area, a DEA Form 106 regarding the loss or theft. There is currently no time limitation for when the DEA Form 106 must be submitted. Registrants regularly submit a Form 106 upon completion of their internal investigation concerning the theft or loss, and then provide updates to the DEA Field Division to the extent that the registrant learns new facts or circumstances surrounding the same. The DEA Form 106 currently may be submitted either in writing (hard copy) or electronically.
DEA proposes to amend the rule to require the registrant to file a “complete and accurate DEA Form 106 with the Administration through the DEA Diversion Control Division secure network application within 15 calendar days after discovery of the theft or loss.” (Emphasis added.) 85 Fed. Reg. at 45551. While we indeed applaud DEA’s proposal to require electronic submissions (as DEA states 99.5 percent of all Form 106’s are already reported electronically), we are curious that DEA seems to be requiring the submission of a “complete and accurate” Form 106 within 15 days of discovery of the theft or significant loss. While this may seem unimportant or even obvious, if the registrant cannot complete the investigation into the significant loss or theft within the 15-day period, then that submission will not, in fact, be “complete” or even “accurate.”
We assume DEA will accept supplemental Form 106’s after the initial 15-day clock has expired. We also assume that a registrant will be permitted to supplement its initial Form 106 to correct any “inaccurate” or “incomplete” information included in the initial Form 106 submission based on the later discovery of additional facts or upon completion of an investigation. Note that DEA is still requiring the submission of an Initial Notification of a theft or significant loss – in writing– within one business day of discovery. DEA’s regulation on the Initial Notification remains unchanged, so a registrant may still submit it in writing to the appropriate DEA Field Division.
DEA also states in its Notice that the proposed amendment would clarify the submission process by aligning it with the current requirements of reporting losses or disappearance of listed chemicals on a DEA Form 107 and not accepting physical copies. DEA Form 107 also must only be submitted electronically, within 15 days of discovery of the circumstances requiring the report.
DEA seeks comments from industry on the following:
- Whether the proposed collection of information is necessary for the proper performance of the functions of DEA, including whether the information will have practical utility.
- The accuracy of DEA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.
- Recommendations to enhance the quality, utility, and clarity of the information to be collected.
- Recommendations to minimize the burden of the collection of information on those who are to respond, including through the use of automated collection techniques or other forms of information technology.
Registrants must submit comments to OMB (include RIN 1117-AB57/Docket No. DEA–574 on the submission) on or before September 28, 2020.