Notice2021-20842
Agency Forms Undergoing Paperwork Reduction Act Review
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
September 27, 2021
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 86 Issue 184 (Monday, September 27, 2021)</title>
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[Federal Register Volume 86, Number 184 (Monday, September 27, 2021)]
[Notices]
[Pages 53303-53304]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-20842]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-21-21DZ]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled Harm Reduction Toolkit for Non-Prescription
Syringe Sales in Community Pharmacies to the Office of Management and
Budget (OMB) for review and approval. CDC previously published a
``Proposed Data Collection Submitted for Public Comment and
Recommendations'' notice on April 5, 2021, to obtain comments from the
public and affected agencies. CDC received one comment related to the
previous notice. This notice serves to allow an additional 30 days for
public and affected agency comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(a) 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;
(b) Evaluate the accuracy of the agencies estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to
be collected;
(d) 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; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570. 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
[[Page 53304]]
``Currently under 30-day Review--Open for Public Comments'' or by using
the search function. Direct written comments and/or suggestions
regarding the items contained in this notice to the Attention: CDC Desk
Officer, Office of Management and Budget, 725 17th Street NW,
Washington, DC 20503 or by fax to (202) 395-5806. Provide written
comments within 30 days of notice publication.
Proposed Project
Harm Reduction Toolkit for Non-Prescription Syringe Sales in
Community Pharmacies--New--National Center for HIV/AIDS, Viral
Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
Injection drug use, through shared use of injection equipment,
increases risk of acquiring blood borne pathogens such as HIV and
hepatitis C virus. While stopping injection drug use is an optimal goal
for preventing transmission of bloodborne pathogens among persons who
inject drugs (PWID), it is not always achievable. However, use of
sterile needles and syringes, for each injection, can significantly
reduce risk of acquiring bloodborne pathogens and access to sterile
syringes can reduce needle sharing among PWID.
Community pharmacies are in a unique position to provide access to
sterile syringes through non-prescription syringe sales (NPSS).
Pharmacies are in this position partly because they are among the most
accessible of healthcare settings. In fact, approximately 90% of urban
costumers live within two miles of a pharmacy, and 70% of rural
costumers are within 15 miles of a pharmacy. Pharmacies also have
extended hours of operations making them more accessible to patients.
While pharmacies represent potential sites for NPSS, education and
tools are needed to build pharmacists' NPSS-related skills and to
support pharmacists in the delivery of NPSS and other harm reduction
services.
The overarching aim of this project is to create harm reduction
products that can help: (1) Facilitate greater access to sterile
syringes through pharmacy-based NPSS, (2) minimize the burden of NPSS
distribution on pharmacists, and (3) improve pharmacy personnel's
understanding of, and skills with, NPSS efforts. The project will
demonstrate how pharmacy personnel can use a contractor developed harm
reduction kit for PWID and online training videos for pharmacy
personnel on NPSS, for HIV prevention.
CDC requests OMB approval to collect standardized data from an in-
field demonstration and evaluation of three contractor developed
resources for harm reduction: Harm reduction kit for PWID; online
training videos for pharmacists and pharmacy personnel regarding NPSS;
and a resource website for PWID. The in-field demonstration and
evaluation will take place at 12 project pharmacies over one six-week
period. The information collection has three primary components: (1)
Online pre-test and post-test surveys, (2) number of pharmacy syringe
sales and service referrals, and (3) website usage (for the training
website and the resource website for PWID). Each pharmacy personnel who
participates in the in-field demonstration will attend an orientation
meeting, complete a one-time online pre-test survey, complete online
training regarding NPSS, and a one-time online post-test survey. The
pre-test survey will be completed in the week prior to the participants
being given access to online training videos for pharmacists and
pharmacy personnel regarding NPSS. The post-test survey will be
completed in the week following the one-week training period. An
estimated 60 pharmacy personnel will complete the pre-test and post-
test surveys. Data from the pre/post-test surveys will be collected
entirely online. The purpose of the surveys is to assess pharmacy
personnel's skills and knowledge pertaining to NPSS before and after
access to the NPSS online training.
Data on pharmacy syringe sales and service referrals (e.g.,
referrals for HIV testing and substance use treatment) will be
collected from each of the 12 participant pharmacy's store or log
records before and after the one-week training period. Each participant
pharmacy's manager will conduct a one-time data collection of
aggregated syringe sales and service referrals data from the 30-day
period before and after the training period. The purpose of the data is
to describe syringe sales and service referrals before and after
pharmacy personnel's access to the NPSS online training. Lastly, one
project director will determine website usage of the training website
and resource locator for PWID.
Training website usage data will be paired with the pre-test and
post-test surveys and skill scores and analyzed for correlations
between usage and knowledge, comfort, and use of NPSS skills. The
numbers of syringe customers and service referrals and usage of the
resource website for PWID will be described.
CDC requests approval for an estimated 217 total annual burden
hours. There are no other costs to respondents other than their time.
Estimated Annualized Burden Hours
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Number of Average burden
Respondents Form name Number of responses per per response
respondents respondent (in hours)
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Pharmacists and pharmacy technicians.. Pharmacy staff 60 1 45/60
orientation protocol.
Pharmacists and pharmacy technicians.. Pre-test survey......... 60 1 30/60
Pharmacists and pharmacy technicians.. Post-test survey *...... 60 1 130/60
Pharmacy manager...................... Pharmacy syringe sales 12 1 1
and service referrals.
Project director...................... Website usage........... 1 1 15/60
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2021-20842 Filed 9-24-21; 8:45 am]
BILLING CODE 4163-18-P
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