Improving HIV Prevention and Treatment Outcomes Among HIV-Infected Persons by Integrating Community Pharmacists and Clinical Sites into a Model of Patient-Centered HIV Care

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Att 9b_Consent form_spanish.docx	Supplementary Document	Uploaded 2014-04-10	Repair queued
Att 9a_Consent form_english.docx	Supplementary Document	Uploaded 2014-04-10	Repair queued
SupSta A.docx	Supporting Statement A	Uploaded 2014-04-10	Repair queued
Att 1_Auth Legislation.pdf	Supplementary Document	Uploaded 2014-03-25	Repair queued
Att 2 60 Day FRN.pdf	Supplementary Document	Uploaded 2014-03-25	Repair queued
SupSta B.docx	Supporting Statement B	Uploaded 2014-03-25	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
211234	Pharmacy Record Abstraction Form	Other-WORD	New
211233	Quarterly Patient Information Form	Other-WORD	New
211230	Initial Patient Information Form	Other-WORD	New
211229	Patient Demographic Information Form	Other-WORD	New
211227	Project Pharmacy Characteristics Form	Other-WORD	New
210930	Project Clinic Characteristics Form	Other-WORD	New

ICR Details

OMB Control No:	ICR Reference No: 201403-0920-014
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-13XA
Title: Improving HIV Prevention and Treatment Outcomes Among HIV-Infected Persons by Integrating Community Pharmacists and Clinical Sites into a Model of 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OIRA Conclusion Action: Withdrawn	Conclusion Date: 05/08/2014
	Date Received in OIRA: 04/15/2014
Terms of Clearance: This was found to be a duplicate of earlier submission. The earlier submission is being retained and reviewed.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	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: 3 USC 301 Name of Law: General Powers and Duties of Public 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

table that charts list of burden

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

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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 request for an OMB Control No.

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Annual Cost to Federal Government: $990,016

Does this IC contain surveys, censuses, or employ statistical methods? No

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: 04/15/2014

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