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

Forms and Documents

Document Name	Status
Project Staff Communication Form - medical providers Form	New
Pharmacy Cost Form Form	Modified
Clinic Staff Cost Form Form	Modified
Project Staff Communication Form - pharmacists Form	Modified
Key Informants Interview Form	Modified
Pharmacy Record Abstraction Form Form	Modified
Quarterly Patient Information Form Form	Modified
Initial Patient Information Form Form	Modified
Patient Demographic Information Form Form	Modified
Project Pharmacy Characteristics Form Form	Modified
Project Clinic Characteristics Form Form	Modified
Att 14_ChangestoICR.docx Supplementary Document	2016-02-17
Att 9b_information form_spanish.docx Supplementary Document	2016-02-17
Att 9a_information form.docx Supplementary Document	2016-02-17
PS-13-1315-UNTHSC.IRB.Approval.Letter.and.Protocol-Summary.pdf Supplementary Document	2016-02-11
Att2 60 Day FRN.pdf Supplementary Document	2016-02-11
Att 1_Auth Legislation.pdf Supplementary Document	2016-02-11
SS B_Clean.docx Supporting Statement B	2016-02-11
SS A_Clean.docx Supporting Statement A	2016-02-11

IC Document Collections

IC ID	Document Title	Status
220127	Project Staff Communication Form - medical providers Form	New
216729	Pharmacy Cost Form Form	Modified
216728	Clinic Staff Cost Form Form	Modified
216727	Project Staff Communication Form - pharmacists Form	Modified
216726	Key Informants Interview Form	Modified
210980	Pharmacy Record Abstraction Form Form	Modified
210979	Quarterly Patient Information Form Form	Modified
210978	Initial Patient Information Form Form	Modified
210977	Patient Demographic Information Form Form	Modified
210976	Project Pharmacy Characteristics Form Form	Modified
210975	Project Clinic Characteristics Form Form	Modified

ICR Details

OMB Control No: 0920-1019	ICR Reference No: 201602-0920-007
Status: Historical Active	Previous ICR Reference No: 201509-0920-012
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Integrating Community Pharmacists and Clinical Sites for Patient-Centered HIV Care
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/09/2016
	Date Received in OIRA: 02/18/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2019	36 Months From Approved	08/31/2018
Responses	10,400	0	10,400
Time Burden (Hours)	6,043	0	6,043
Cost Burden (Dollars)	0	0	0

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Abstract: This project intended to develop and implement a model of HIV care that integrates community pharmacists with primary medical providers for patient-centered HIV care. This revision seeks to add a staff communication questionnaire for medical providers.

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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:
	80 FR 71806	11/17/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 8203	02/18/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 11

IC Title	Form No.	Form Name
Clinic Staff Cost Form	none	Clinic Cost Form
Pharmacy Cost Form	none	Pharmacy Cost Form
Project Clinic Characteristics Form	none	Project Clinic Characteristics
Project Staff Communication Form - medical providers	none	Staff Communication Form - medical providers
Project Pharmacy Characteristics Form	none	Project Pharmacy Characteristics
Patient Demographic Information Form	none	Patient Demographic Information
Initial Patient Information Form	none	Initial Patient Information
Quarterly Patient Information Form	none, none	Quarterly Patient Information ,   Quarterly Patient Information - screenshots
Pharmacy Record Abstraction Form	none	Pharmacy Record Abstraction
Key Informants Interview	none	Interviewer Data Collection
Project Staff Communication Form - pharmacists	none	Staff Communication Form - pharmacist

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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	10,400	10,400	0	0	0	0
Annual Time Burden (Hours)	6,043	6,043	0	0	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: A Staff Communication Form for medical providers has been added and the number of respondents to the staff communication form for pharmacists has been reduced. No changes in estimated burden are expected.

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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: 02/18/2016

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