Agency Information Collection Activities; Proposed eCollection eComments Requested; New Information Collection Request; Emergency Medical Services Recordkeeping and Notice Requirements

SUPPLEMENTARY INFORMATION:

Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:

—Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Bureau of Justice Statistics, including whether the information will have practical utility;

—Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

—Evaluate whether and if so how the quality, utility, and clarity of the information to be collected can be enhanced; and

—Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

Abstract: The Controlled Substances Act (CSA) (21 U.S.C. 801-971) requires all persons who handle controlled substances to obtain a registration from the Attorney General. 21 U.S.C. 822, 823, 831, 957, and 958. The “Protecting Patient Access to Emergency Medications Act of 2017,” (hereafter the “Act”) which became law on November 17, 2017, amended the Controlled Substances Act to allow for a new registration category for emergency medical services agencies that handle controlled substances. It also established standards for registering emergency medical services agencies, and set forth new requirements for delivery, storage, and recordkeeping related to their handling of controlled substances.

With this proposed collection, DEA is proposing recordkeeping regulations for EMS agencies to incorporate the Act's CSA amendments regarding recordkeeping, and to ensure an accurate accounting of the controlled substances outside the two-registrant integrity system.

The Act require EMS agencies to maintain records of the EMS personnel whose State license or certification gives them the ability to administer controlled substances, in compliance with their State laws. Under 21 U.S.C 827(b), controlled substance records for all DEA registrants are required to be maintained for at least two years from the date of such inventory or records. Following the Act, 21 U.S.C. 823(k)(9)(B)(ii), DEA would require that records be maintained, whether electronically or otherwise, at each registered and designated location of the agency where the controlled substances involved are received, administered, or otherwise disposed of.

Consistent with the Act's amendments to the CSA, 21 U.S.C. 823(k)(9), DEA would require an EMS agency to maintain records for each controlled substance administered or disposed of in the course of providing emergency medical services. In addition, any EMS personnel who disposes of or administers controlled substances to a patient in the course of providing emergency medical care would have to record the name of the controlled substance(s) and detailed information about the circumstances surrounding the administration of the controlled substance(s) ( e.g., name of the substance, date dispensed, identification of the patient).

Additionally, in accordance with 21 U.S.C 821(k)(9)(b), that an EMS agency must maintain records of controlled substances delivered between registered and designated locations of the agency (except agencies restocking at the hospital under which the EMS agency is operating, because the hospital is required to keep records of such restocking). These records, for example, should include the name of the controlled substance(s), finished form, number of units in the commercial container, date delivered, and the address of the EMS agency location where the controlled substances were delivered.

Overview of This information Collection

1. Type of Information Collection: New information collection.

2. The Title of the Form/Collection: Emergency Medical Services Recordkeeping and Notice Requirements.

3. The agency form number, if any, and the applicable component of the Department sponsoring the collection: No form number is associated with this collection. The applicable component within the Department of Justice is the Drug Enforcement Administration, Diversion Control Division.

4. Affected public who will be asked or required to respond, as well as the obligation to respond: Affected Public: (Primary) Business or other for-profit.

5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: The DEA estimates that 21,283 Registrants participate in this information collection. The time per response is 5 minutes.

6. An estimate of the total annual burden (in hours) associated with the collection: DEA Estimates that this collection takes 92,226 annual burden hours.

7. An estimate of the total annual cost burden associated with the collection, if applicable: $0.