Integrating Community Pharmacists and Clinical Sites for Patient-Centered HIV Care

Forms and Documents

Document Name	Status
SupSta B.docx Supporting Statement B	2014-03-25
Att 2 60 Day FRN.pdf Supplementary Document	2014-03-25
Att 1_Auth Legislation.pdf Supplementary Document	2014-03-25
Att 9b_Consent form_spanish.docx Supplementary Document	2014-03-25
Att 9a_Consent form_english.docx Supplementary Document	2014-03-25
SupSta A.docx Supporting Statement A	2014-03-25

IC Document Collections

IC ID	Document Title	Status
210980	Pharmacy Record Abstraction Form Other-WORD	New
210979	Quarterly Patient Information Form Instruction	New
210978	Initial Patient Information Form Instruction	New
210977	Patient Demographic Information Form Other-WORD	New
210976	Project Pharmacy Characteristics Form Other-WORD	New
210975	Project Clinic Characteristics Form Other-WORD	New

ICR Details

OMB Control No: 0920-1019	ICR Reference No: 201403-0920-016
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 21630
Title: Integrating Community Pharmacists and Clinical Sites for Patient-Centered HIV Care
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: 05/16/2014
	Date Received in OIRA: 03/28/2014
Terms of Clearance: Approved with the understanding that this pilot project is formative in nature and the results will not be able to be generalized. Given that this is not a randomized controlled design, effectiveness of the intervention cannot be robustly assessed through this ICR.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2017	36 Months From Approved
Responses	10,060	0	0
Time Burden (Hours)	5,113	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: CDC has partnered with Walgreen pharmacies to develop and implement a model of HIV care that integrates community pharmacists with primary medical providers for patient-centered HIV care. The model program will include the core elements of Medication Therapy Management as well as additional services such as individualized medication adherence counseling, active monitoring of prescription refills and active collaboration with medical clinic providers to identify and resolve medication related treatment problems such as treatment effectiveness, adverse events and poor adherence. The pilot program will be conducted in ten project sites. Each project site will be made up of at least one Walgreens pharmacy and one medical clinic with which the pharmacy will partner. A total of 1000 HIV-infected persons (~100 patients per site) will be enrolled in the patient-centered HIV care project. The project sites will enroll minority populations disproportionately affected by HIV. Walgreens will provide expanded MTM services to participants of the pilot program and will work with medical clinic providers to implement the service model. Each project participant will receive patient-centered HIV care services for 18-24 months. The expected project outcomes are increased retention in care, adherence to HIV medication therapy and HIV viral load suppression.

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Authorizing Statute(s): US Code: 42 USC 301 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:
	78 FR 36550	06/18/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 16002	03/24/2014
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Project Clinic Characteristics Form
Project Pharmacy Characteristics Form
Patient Demographic Information Form
Initial Patient Information Form
Quarterly Patient Information Form
Pharmacy Record Abstraction Form

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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	10,060	0	0	10,060	0	0
Annual Time Burden (Hours)	5,113	0	0	5,113	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 collection request for a new OMB Control Number.

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Annual Cost to Federal Government: $990,016

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? 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? 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: 03/28/2014

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