Evaluation of Pharmacy Syringe Access Linked to HIV Testing for Injection Drug Users in New York City (Pharm-HIV)

Forms and Documents

Document Name	Status
09AF_SS_SectB_090209.doc Supporting Statement B	2009-09-03
09AF_Att6a_CDC IRB Approval.pdf Supplementary Document	2009-09-04
09AF_Att2_60 Day FRN.pdf Supplementary Document	2009-09-03
09AF_Att1b_legislation Sect 308(d) .pdf Supplementary Document	2009-09-03
09AF_Att1a_legislation Sect301.pdf Supplementary Document	2009-09-03
09AF_Att4d_Syringe Customer Participant In-Pharmacy Testing Consent.doc Supplementary Document	2009-09-04
09AF_Att4c_Syringe Customer Participant Referral Consent.doc Supplementary Document	2009-09-04
09AF_Att4b_Pharmacy Staff Consent 0920-09XX.doc Supplementary Document	2009-09-04
092009AF_att4a_Pharmacist Consent_121009.doc Supplementary Document	2009-12-11
0920-09AF_SS_SectA_121009.doc Supporting Statement A	2009-12-11

IC Document Collections

IC ID	Document Title	Status
190726	Evaluation of Pharmacy Syringe Access Linked to HIV Testing for Injection Drug Users in New York City (Pharm-HIV) - Pharmacy Telephone Screening and Enrollment Form Other-WORD	New
190725	Evaluation of Pharmacy Syringe Access Linked to HIV Testing for Injection Drug Users in New York City (PHarm-HIV) Pharmlink Participant Baseline Survey (Syringe Customer) Other-WORD	New
190724	Evaluation of Pharmacy Syringe Access Linked to HIV Testing for Injection Drug Users in New York City (PHarm-HIV) Pharmacy Staff Exit Surve (Pharmacists and Pharmacy Technicians) Other-WORD	New
190723	Evaluation of Pharmacy Syringe Access Linked to HIV Testing for Injection Drug Users in New York City (PHarm-HIV) Syringe Transaction and Referral Log (Pharmacy Technicians) Other-WORD	New
190722	Evaluation of Pharmacy Syringe Access Linked to HIV Testing for Injection Drug Users in New York City (PHarm-HIV) Pharmacy Staff Monthly Survey (Pharmacists) Other-WORD	New
190721	Evaluation of Pharmacy Syringe Access Linked to HIV Testing for Injection Drug Users in New York City (Pharm-HIV) - Pharmacy Monthly Survey (Pharmacists) Other-WORD	New
190720	"Evaluation of Pharmacy Syringe Access Linked to HIV Testing for Injection Drug Users in New York City (Pharm-HIV)" - Pharmacy Staff Baseline Survey (Pharmacist) Other-WORD	New

ICR Details

OMB Control No: 0920-0837	ICR Reference No: 200909-0920-010
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Evaluation of Pharmacy Syringe Access Linked to HIV Testing for Injection Drug Users in New York City (Pharm-HIV)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/08/2010
	Date Received in OIRA: 09/17/2009
Terms of Clearance: Approval is provided for 18 months of data collection; a longer clearance period is given to provide a buffer for delays associated with recuiting.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2013	36 Months From Approved
Responses	4,141	0	0
Time Burden (Hours)	496	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This project involves two kinds of studies: testing service models at pharmacies and, interviewing individuals regarding the availability of syringes through pharmacies. For testing service models CDC will collaborate with the New York Academy of Medicine (NYAM) to implement this project for a period of three years. The NYAM will identify 12 ESAP pharmacies in East Harlem, New York City; ten of which will test a model that refers injection-drug-using syringe customers for HIV testing to local HIV testing sites. Two ESAP pharmacies will evaluate the feasibility of offering and performing HIV counseling and testing in the pharmacy for injection-drug-using syringe customers. Two types of respondents will provide the individual-level data; forty-eight adult (age >18 yrs) pharmacy staff members will be surveyed to learn about pharmacy staff attitudes and behaviors regarding HIV testing and referral. The other respondent group will be 442 adult (age >18 yrs) injection-drug-using syringe customers who will complete a brief quantitative interview after HIV referral or HIV testing is offered to them. HIV-seropositive injection-drug-using syringe customers identified during HIV testing will be immediately linked to social and medical services.

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Authorizing Statute(s): US Code: 42 USC 301 Name of Law: Public Health Service Act
   US Code: 42 USC 308d Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

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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:
	73 FR 69663	11/19/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 168	09/01/2009
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
"Evaluation of Pharmacy Syringe Access Linked to HIV Testing for Injection Drug Users in New York City (Pharm-HIV)" - Pharmacy Staff Baseline Survey (Pharmacist)
Evaluation of Pharmacy Syringe Access Linked to HIV Testing for Injection Drug Users in New York City (PHarm-HIV) Pharmacy Staff Exit Surve (Pharmacists and Pharmacy Technicians)
Evaluation of Pharmacy Syringe Access Linked to HIV Testing for Injection Drug Users in New York City (PHarm-HIV) Pharmlink Participant Baseline Survey (Syringe Customer)
Evaluation of Pharmacy Syringe Access Linked to HIV Testing for Injection Drug Users in New York City (Pharm-HIV) - Pharmacy Telephone Screening and Enrollment Form
Evaluation of Pharmacy Syringe Access Linked to HIV Testing for Injection Drug Users in New York City (Pharm-HIV) - Pharmacy Monthly Survey (Pharmacists)
Evaluation of Pharmacy Syringe Access Linked to HIV Testing for Injection Drug Users in New York City (PHarm-HIV) Pharmacy Staff Monthly Survey (Pharmacists)
Evaluation of Pharmacy Syringe Access Linked to HIV Testing for Injection Drug Users in New York City (PHarm-HIV) Syringe Transaction and Referral Log (Pharmacy Technicians)

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ICR Summary of Burden

	Total Approved	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	4,141	0	0	4,141	0	0
Annual Time Burden (Hours)	496	0	0	496	0	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 collection.

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Annual Cost to Federal Government: $346,797

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? Yes

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

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

Is this ICR related to the Pandemic Response? Uncollected

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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: 09/17/2009

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