[Federal Register Volume 86, Number 63 (Monday, April 5, 2021)]
[Notices]
[Pages 17604-17606]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06881]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-2021-21DZ; Docket No. CDC-2021-0031]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled Harm Reduction Toolkit for Non-
Prescription Syringe Sales in Community Pharmacies. The aim of the 
project is to create harm reduction products that can help: (1) 
Facilitate greater access to sterile syringes through pharmacy-based 
non-prescription syringe sales (NPSS), (2) minimize the burden of NPSS 
distribution on pharmacists, and (3) improve pharmacy personnel's 
understanding of, and skills with, NPSS efforts.

DATES: CDC must receive written comments on or before June 4, 2021.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2021-
0031 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to Regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (regulations.gov) or by U.S. mail to the address listed above.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact Jeffrey M. Zirger, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7118; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. 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;
    2. 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;
    3. Enhance the quality, utility, and clarity of the information to 
be collected; and

[[Page 17605]]

    4. 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 
submissions of responses.
    5. Assess information collection costs.

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 (HCV). 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 persons who inject 
drugs (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). Pharmacy 
personnel who participate in the in-field demonstration will complete a 
one-time online pre-test survey 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 the online training videos for 
pharmacists and pharmacy personnel regarding NPSS and 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 pharmacies 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 these 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 OMB approval for an estimated 73 annual burden hours. 
There are no costs to respondents other than their time.

                                        Estimated Annualized Burden Hours
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                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondents           Form name       respondents    responses per   response (in        hours
                                                                    respondent        hours)
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Pharmacists and pharmacy        Pre-test survey.              60               1           30/60              30
 technicians.
Pharmacists and pharmacy        Post-test survey              60               1           30/60              30
 technicians.
Pharmacy manager..............  Pharmacy syringe              12               1           60/60              12
                                 sales and
                                 service
                                 referrals.
Project director..............  Website usage...               1               1           15/60               1
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............              73
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[[Page 17606]]

Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2021-06881 Filed 4-2-21; 8:45 am]
BILLING CODE 4163-18-P