[Federal Register Volume 86, Number 209 (Tuesday, November 2, 2021)]
[Notices]
[Page 60472]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23791]



[[Page 60472]]

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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: 30-Day notice.

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SUMMARY:  The Department of Justice (DOJ), Drug Enforcement 
Administration (DEA), 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 30 days until 
December 2, 2021.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.

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.

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 requires that each registered practitioner apply to 
an approved credential service provider 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 permission 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 
conducts 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: October 27, 2021.
Melody Braswell,
Department Clearance Officer for PRA, U.S. Department of Justice.
[FR Doc. 2021-23791 Filed 11-1-21; 8:45 am]
BILLING CODE 4410-09-P