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

Forms and Documents

Document Name	Status
Pharmacy Cost Form Form	New
Clinic Staff Cost Form Form	New
Project Staff Communication Questionnaire Form	New
Key Informants Interview Form	New
Project Determination 0920-1019.pdf Supplementary Document	2015-05-19
Att 2a_Public Comment.docx Supplementary Document	2015-05-19
Att 2_60-Day FRN.pdf Supplementary Document	2015-05-19
Supporting Statement B.docx Supporting Statement B	2015-05-19
Supporting Statement A_OMB comments_KB_clean copy.docx Supporting Statement A	2015-08-06
Att 1_Auth Legislation.pdf Supplementary Document	2014-03-25

IC Document Collections

IC ID	Document Title	Status
216729	Pharmacy Cost Form Form	New
216728	Clinic Staff Cost Form Form	New
216727	Project Staff Communication Questionnaire Form	New
216726	Key Informants Interview Form	New
210980	Pharmacy Record Abstraction Form Other-WORD	Unchanged
210979	Quarterly Patient Information Form Instruction	Unchanged
210978	Initial Patient Information Form Instruction	Unchanged
210977	Patient Demographic Information Form Other-WORD	Unchanged
210976	Project Pharmacy Characteristics Form Other-WORD	Unchanged
210975	Project Clinic Characteristics Form Other-WORD	Unchanged

ICR Details

OMB Control No: 0920-1019	ICR Reference No: 201505-0920-005
Status: Historical Active	Previous ICR Reference No: 201406-0920-009
Agency/Subagency: HHS/CDC	Agency Tracking No: 21630
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 with change	Conclusion Date: 08/17/2015
	Date Received in OIRA: 06/04/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2018	36 Months From Approved	05/31/2017
Responses	10,400	0	10,060
Time Burden (Hours)	6,043	0	5,113
Cost Burden (Dollars)	0	0	0

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Abstract: The Centers for Disease Control and Prevention (CDC) has started the development and implementation of a model of HIV care that integrates community pharmacists with primary medical providers for patient-centered HIV care. This revision request will help CDC determine changes to clinic and pharmacy work systems, processes and outcomes in relation to the model project and how and if the model program improves patient outcomes through improved communication and collaboration between patients' clinical providers and pharmacists.

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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 5114	01/30/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 30682	05/29/2015
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 10

IC Title	Form No.	Form Name
Key Informants Interview	none, none	Interviewer Data Collection Worksheet ,   Revised Key Informant Interview Script
Project Staff Communication Questionnaire	none	Revised Staff Communication Questionnaire
Clinic Staff Cost Form	none	Revised Clinic Cost Form
Pharmacy Cost Form	none	Revised Pharmacy Cost Form
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	10,400	10,060	0	340	0	0
Annual Time Burden (Hours)	6,043	5,113	0	930	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 revision request includes new data collection instruments that cause an increase in the total burden hours.

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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: 06/04/2015

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