Patient Navigator Demonstration Program Evaluation

Forms and Documents

Document Name	Status
Response to OMB Comments 08_13_09_PNDP.pdf Supplementary Document	2009-08-31
Response to OMB 06_30_2009_PNDP ICR.pdf Supplementary Document	2009-08-31
PNDP Grantee Abstracts_08-11-09.pdf Supplementary Document	2009-08-31
HRSA PNDP Eval Matrix_revised.pdf Supplementary Document	2009-08-31
HRSA PNDP Data Dictionary_updated.pdf Supplementary Document	2009-08-31
HRSA PNDP Data Collection Elements_revised.pdf Supplementary Document	2009-08-31
LogicModelv4-1.pdf Supplementary Document	2009-03-19
HRSA PNDP Eval MatrixDRAFT 2-3-09.pdf Supplementary Document	2009-03-19
Data Element Summary.pdf Supplementary Document	2009-03-19
Attachment D - Patient Navigator Act of 2005.pdf Supplementary Document	2009-03-19
Attachment C - QuarterlyReport.pdf Supplementary Document	2009-03-19
Attachment B - Patient Tracking Log.pdf Supplementary Document	2009-03-19
Attachment A - HRSA PNDP Data Dictionary.pdf Supplementary Document	2009-03-19
Supporting Statement - Patient Navigator Demonstration Program Evaluation.pdf Supporting Statement A	2009-03-19

IC Document Collections

IC ID	Document Title	Status
188564	Patient Navigator Demonstration Program Evaluation - Grantee Level Other-Data Dictionary	New
188563	Patient Navigator Demonstration Program Evaluation - Patient Navigator Level Other-Data Dictionary	New
188562	Patient Navigator Demonstration Program Evaluation - Patient Level Other-Data Dictionary	New

ICR Details

OMB Control No: 0915-0328	ICR Reference No: 200903-0915-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/HSA	Agency Tracking No:
Title: Patient Navigator Demonstration Program Evaluation
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: 08/31/2009
	Date Received in OIRA: 03/26/2009
Terms of Clearance: This ICR is approved consistent with revised instruments and supporting materials and HRSA memos of 6/30/09, 8/13/09, and 8/20/09. In particular, HRSA agrees to acknowledge the exploratory and descriptive nature of these site-specific studies (and thus limitations to both their internal and external validity) in all public disclosures of study results, including the Report to Congress. HRSA also acknowledges that the exploratory nature of the study design does not enable the study sites or HRSA to infer that any results stem from the Patient Navigator programs, as more experimental study designs utilizing control groups would be necessary to draw such conclusions. Thus, HRSA will aim to avoid language that implies such causal relationships (e.g. avoiding language like "the Patient Navigator program worked"). Finally, HRSA agrees to brief OMB on the study results and how they will be presented in the Report to Congress, prior to publication. According to HRSA's timeline, HRSA will receive a draft report by the end of September, with the final report going to Congress by the end of March. HRSA should, therefore, aim to brief OMB by the end of December 2010.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2010	36 Months From Approved
Responses	40,590	0	0
Time Burden (Hours)	20,693	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Six grants have been awarded to eligible entities for the development and operation of demonstration programs to provide patient navigator services to improve health careoutcomes. The Patient Navigator Outreach and Chronic Disease Prevention Demonstration Program should demonstrate how local initiatives can potentially reduce the burden of cancer and other chronic diseases such as obesity, diabetes, asthma and others by reducing the barriers related to accessing high quality health care services. This evaluation consists of two parts: 1) an evaluation of the patient navigators themselves; and 2) an evaluation of health outcomes of the patients who will be navigated.

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Authorizing Statute(s): US Code: 42 USC 256A Name of Law: Public Health Service Act
   PL: Pub.L. 109 - 18 1812 Name of Law: Patient Navigator Outreach and Chronic Disease Prevention Demonstration Act of 2005
  

Citations for New Statutory Requirements: PL: Pub.L. 109 - 18 1812 Name of Law: Patient Navigator Outreach and Chronic Disease Prevention Demonstration Act of 2005

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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:
	73 FR 72064	11/26/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 10599	03/11/2009
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Patient Navigator Demonstration Program Evaluation - Patient Level
Patient Navigator Demonstration Program Evaluation - Patient Navigator Level	001 - Patient Navigator Tracking Log	Patient Navigator Tracking Log
Patient Navigator Demonstration Program Evaluation - Grantee Level	003- Patient Navigator Grantee Quarterly Report	Patient Navigator Grantee Quarterly Report

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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	40,590	0	40,590	0	0	0
Annual Time Burden (Hours)	20,693	0	20,693	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: The Patient Navigator Outreach and Chronic Disease Prevention Demonstration Act of 2005 mandated an evaluation of the Patient Navigator Demonstration Program funded by the Health Resources and Services Administration.

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Annual Cost to Federal Government: $395,680

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

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: 03/26/2009

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