Positive Health Check Evaluation Trial

Forms and Documents

Document Name	Status
PHC Non-Labor Cost Questionnaire Form and Instruction	New
Standard of Care Questionnaire Form and Instruction	New
PHC Labor Cost Questionnaire Form and Instruction	New
Non-Research Labor Cost Questionnaire Form and Instruction	New
Clinic Staff Qualitative Interview Guide Form and Instruction	New
Clinic Staff Survey Form and Instruction	New
Electronic Medical Records (EMR) Form and Instruction	New
PHC Tailoring Questions Form and Instruction	New
Date of Diagnosis Question Form and Instruction	New
Att 16 PHC Sample Patient Handout.pdf Supplementary Document	2017-06-30
Att 15 Recruitment Scripts for Clinic Staff CLEAN 12.13.17.._.docx Supplementary Document	2017-12-13
Att 9 Consent Form CLEAN 12.13.17.docx Supplementary Document	2017-12-13
Att 5 IRB approval.pdf Supplementary Document	2017-06-30
Att 4 Positive Health Check Screenshots.5.11.17docx.docx Supplementary Document	2017-06-30
Att 3 References (1) CLEAN 12.13.17.docx Supplementary Document	2017-12-13
Att 2 60 Day FRN.pdf Supplementary Document	2017-06-30
Att 1 Auth legislation.docx Supplementary Document	2017-06-30
PHC SSB CLEAN CH 12.15.17 FINAL.DOCX Supporting Statement B	2017-12-15
SS A 12.15.17 CH CLEAN_FINAL .docx Supporting Statement A	2017-12-15

IC Document Collections

IC ID	Document Title	Status
227363	PHC Non-Labor Cost Questionnaire Form and Instruction	New
227362	Standard of Care Questionnaire Form and Instruction	New
227361	PHC Labor Cost Questionnaire Form and Instruction	New
227360	Non-Research Labor Cost Questionnaire Form and Instruction	New
227359	Clinic Staff Qualitative Interview Guide Form and Instruction	New
227358	Clinic Staff Survey Form and Instruction	New
227356	Electronic Medical Records (EMR) Form and Instruction	New
227355	PHC Tailoring Questions Form and Instruction	New
227354	Date of Diagnosis Question Form and Instruction	New

ICR Details

OMB Control No: 0920-1211	ICR Reference No: 201706-0920-012
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-17CA
Title: Positive Health Check Evaluation Trial
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 with change	Conclusion Date: 12/22/2017
	Date Received in OIRA: 07/05/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2020	36 Months From Approved
Responses	1,077	0	0
Time Burden (Hours)	419	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The purpose of this data collection is to evaluate the effectiveness of Positive Health Check (PHC), an online tool created by RTI and CDC that delivers tailored evidence based prevention messages to HIV positive patients, on improving clinical outcomes and retention in care of HIV positive patients with unsuppressed viral loads.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: U.S. PHSA
  

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:
	81 FR 76590	11/03/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 29861	06/30/2017
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 9

IC Title	Form No.	Form Name
Date of Diagnosis Question	NA	Date of Diagnosis Question - Att 6
PHC Tailoring Questions	NA	PHC Tailoring Questions - Att 7
Electronic Medical Records (EMR)	NA	Electronic Medical Record (EMR) - Data Dictionary - Att 8
Non-Research Labor Cost Questionnaire	NA	Non-research labor cost questionnaire - Att 12
Clinic Staff Survey	NA	Clinic Staff Survey - PHC Evaluation - Att 10
Clinic Staff Qualitative Interview Guide	NA	Clinic Staff Qualitative Interview Guide - Att 11
PHC Labor Cost Questionnaire	NA	PHC Labor Cost Questionnaire - Att 13
PHC Non-Labor Cost Questionnaire	NA	PHC Non-Labor Cost Questionnaire - Att 17
Standard of Care Questionnaire	NA	Standard of Care Questionnaire - Att 14

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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	1,077	0	0	1,077	0	0
Annual Time Burden (Hours)	419	0	0	419	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: Submission of 0920-17CA is a New ICR.

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Annual Cost to Federal Government: $1,755,401

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 07/05/2017

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