[Federal Register Volume 86, Number 184 (Monday, September 27, 2021)]
[Notices]
[Pages 53303-53304]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 www.reginfo.gov/public/do/PRAMain. 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