Notice2021-23791
Agency Information Collection Activities: Proposed eCollection, eComments Requested; Reinstatement of a Discontinued Collection: Recordkeeping for Electronic Prescriptions for Controlled Substances
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 2, 2021
Issuing agencies
Justice Department
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 209 (Tuesday, November 2, 2021)</title>
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[Federal Register Volume 86, Number 209 (Tuesday, November 2, 2021)]
[Notices]
[Page 60472]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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
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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
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.