86 FR 184 pgs. 53303-53304 - Agency Forms Undergoing Paperwork Reduction Act Review
Type: NOTICEVolume: 86Number: 184Pages: 53303 - 53304
Pages: 53303, 53304Docket number: [30Day-21-21DZ]
FR document: [FR Doc. 2021-20842 Filed 9-24-21; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Centers for Disease Control and Prevention
Official PDF Version: PDF Version
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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.
[top] 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
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.
| Respondents | Form name | Number of respondents | Number of responses per respondent | Average burden per response (in hours) |
|---|---|---|---|---|
| Pharmacists and pharmacy technicians | Pharmacy staff orientation protocol | 60 | 1 | 45/60 |
| 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 and service referrals | 12 | 1 | 1 |
| Project director | Website usage | 1 | 1 | 15/60 |
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