[Federal Register Volume 86, Number 156 (Tuesday, August 17, 2021)]
[Notices]
[Pages 46016-46017]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-17523]


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DEPARTMENT OF JUSTICE

[OMB Number 1117-0049]


Agency Information Collection Activities: Proposed eCollection, 
eComments Requested; Reinstatement of a Discontinued Collection: 
Recordkeeping for Electronic Prescriptions for Controlled Substances

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: 60-Day notice.

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SUMMARY: The Drug Enforcement Administration (DEA), Department of 
Justice (DOJ), will be submitting the following information collection 
request to the Office of Management and Budget (OMB) for review and 
approval in accordance with the Paperwork Reduction Act of 1995.

DATES: Comments are encouraged and will be accepted for 60 days until 
October 18, 2021.

FOR FURTHER INFORMATION CONTACT: If you have comments on the estimated 
public burden or associated response time, suggestions, or need a copy 
of the proposed information collection instrument with instructions or 
additional information, please contact Scott A. Brinks, Diversion 
Control Division, Drug Enforcement Administration; Mailing Address: 
8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (571) 
362-3261.

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 agency, 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 proposed 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 forms of information technology, e.g., 
permitting electronic submission of responses.

[[Page 46017]]

Overview of This Information Collection

    1. Type of Information Collection: Reinstatement of a discontinued 
collection.
    2. Title of the Form/Collection: Recordkeeping for Electronic 
Prescriptions for Controlled Substance.
    3. The agency form number, if any, and the applicable component of 
the Department sponsoring the collection: There is no form number. 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 a brief abstract:
    Affected public (Primary): Business or other for-profit.
    Affected public (Other): Not-for-profit institutions; Federal, 
State, local, and tribal governments.
    Abstract: DEA is requiring that each registered practitioner apply 
to an approved credential service provider approved to obtain identity 
proofing and a credential. Hospitals and other institutional 
practitioners may conduct this process in-house as part of their 
credentialing. For practitioners currently working at or affiliated 
with a registered hospital or clinic, the hospital/clinic have to check 
a government-issued photographic identification. This may be done when 
the hospital/clinic issues credentials to new hires or newly affiliated 
physicians. For individual practitioners, two people need to enter 
logical access control data to grant permissions for practitioners 
authorized to approve and sign controlled substance prescriptions using 
the electronic prescription application. For institutional 
practitioners, logical access control data is entered by two people 
from an entity within the hospital/clinic that is separate from the 
entity that conduct identity proofing in-house. Similarly, pharmacies 
have to set logical access controls in the pharmacy application so that 
only authorized employees have permission to annotate or alter 
prescription records. Finally, if the electronic prescription or 
pharmacy application generates an incident report, practitioners, 
hospitals/clinics, and pharmacies have to review the incident report to 
determine if the event identified by the application represents a 
security incident.
    5. An estimate of the total number of respondents and the amount of 
time estimated for an average respondent to respond: The below table 
presents information regarding the number of respondents, hour burden 
per responses and associated burden hours.

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                                                                     Number of      Hour burden
                                                                    respondents    per response    Burden hours
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Practitioners...................................................          78,164            0.67          52,370
MLP.............................................................          49,067            0.67          32,875
Hospital/Clinics................................................           1,482            2.13           3,157
Pharmacies......................................................           3,984            0.33           1,315
                                                                 -----------------------------------------------
    Total.......................................................         132,697  ..............          89,717
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    6. An estimate of the total public burden (in hours) associated 
with the proposed collection: DEA estimates that this collection takes 
89,717 annual burden hours.
    If additional information is required please contact: Melody 
Braswell, Department Clearance Officer, United States Department of 
Justice, Justice Management Division, Policy and Planning Staff, Two 
Constitution Square, 145 N Street NE, Suite 3E.405B, Washington, DC 
20530.

    Dated: August 11, 2021.
Melody Braswell,
Department Clearance Officer for PRA, U.S. Department of Justice.
[FR Doc. 2021-17523 Filed 8-16-21; 8:45 am]
BILLING CODE 4410-09-P