Harm Reduction Toolkit for Non-Prescription Syringe Sales in Community Pharmacies

Forms and Documents

Document Name	Status
Form 0920-21DZ Harm Reduction Toolkit for Non-Prescription Syringe Sales in Community Pharmacies (Post-Test) Form	New
Form 0920-21DZ Harm Reduction Toolkit for Non-Prescription Syringe Sales in Community Pharmacies (Pre-Test) Form	New
Attachment 10_IRB Approval letter.pdf Supplementary Document	2021-09-14
Attachment 5_Consent form.docx Supplementary Document	2021-09-14
Attachment 4_Study email invitation.docx Supplementary Document	2021-09-14
Attachment 1_Authorizing legislation.pdf Supplementary Document	2021-09-14
Supporting Statement B_30 day_2 August.docx Supporting Statement B	2021-09-14
Supporting Statement A_30 day_2 August.docx Supporting Statement A	2021-09-14

IC Document Collections

IC ID	Document Title	Status
249322	Website usage variables Other-WORD	New
249321	Syringe Sales and Service referrals variables Other-WORD	New
249320	Harm Reduction Toolkit for Non-Prescription Syringe Sales in Community Pharmacies (Post-Test) Form	New
249319	Harm Reduction Toolkit for Non-Prescription Syringe Sales in Community Pharmacies (Pre-Test) Form	New
249318	Harm Reduction toolkits for Non-Prescription Syringe Sales in Community Pharmacies Other-WORD	New

ICR Details

OMB Control No:	ICR Reference No: 202107-0920-011
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-21DZ
Title: Harm Reduction Toolkit for Non-Prescription Syringe Sales in Community Pharmacies
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 10/19/2021

	Requested	Previously Approved
Expiration Date	24 Months From Approved
Responses	193	0
Time Burden (Hours)	217	0
Cost Burden (Dollars)	0	0

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Abstract: The overarching 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. Data collected will be used to demonstrate how pharmacy personnel and persons who inject drugs (PWID) can use three contractor developed resources for harm reduction: a harm reduction kit for PWID; online training videos for pharmacists and pharmacy personnel pertaining to NPSS; and a resource website for PWID.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: US Code: 42 USC 241 Name of Law: Public Health Service Act

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 17604	04/05/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 53303	09/27/2021
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Harm Reduction Toolkit for Non-Prescription Syringe Sales in Community Pharmacies (Post-Test)	0920-21DZ	Harm Reduction Toolkit for Non-Prescription Syringe Sales in Community Pharmacies (Post-Test Survey)
Harm Reduction Toolkit for Non-Prescription Syringe Sales in Community Pharmacies (Pre-Test)	0920-21DZ	Harm Reduction Toolkit for Non-Prescription Syringe Sales in Community Pharmacies (Pre-Test Survey)
Harm Reduction toolkits for Non-Prescription Syringe Sales in Community Pharmacies
Syringe Sales and Service referrals variables
Website usage variables

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	193	0	0	132	61	0
Annual Time Burden (Hours)	217	0	0	87	130	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new data/information collection.

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Annual Cost to Federal Government: $664,082

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 10/19/2021

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