PACT Evaluating Peer Notifications to Improve Statin Medication Adherence among Patients with Coronary Artery Disease

Forms and Documents

Document Name	Status
Form 10-10139 Evaluating Peer Notifications to Improve Statin Medication Adherence among Patients with Coronary Artery Disease Form and Instruction	New
20160607_V4_StainMed_CAD_protocolsummaryFeb2016.pdf Supplementary Document	2016-06-15
20160607_V4_StainMed_CAD_ICRJustfctnB_OMBrvw.doc Supporting Statement B	2016-06-15
60-Day FRN.pdf Supplementary Document	2015-12-07
30 Day FRN.pdf Supplementary Document	2015-12-07
20160607_V4_StainMed_CAD_ICRJustfctnA_OMBrvw.doc Supporting Statement A	2016-06-16

IC Document Collections

IC ID	Document Title	Status
212921	Evaluating Peer Notifications to Improve Statin Medication Adherence among Patients with Coronary Artery Disease Form and Instruction	New

ICR Details

OMB Control No: 2900-0848	ICR Reference No: 201409-2900-006
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: VA	Agency Tracking No:
Title: PACT Evaluating Peer Notifications to Improve Statin Medication Adherence among Patients with Coronary Artery Disease
Type of Information Collection: Existing collection in use without an OMB Control Number	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 08/19/2016
	Date Received in OIRA: 12/07/2015
Terms of Clearance: We appreciate VA's agreement to submit future PACT initiative studies to OMB for advance approval.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2019	36 Months From Approved
Responses	224	0	0
Time Burden (Hours)	784	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Despite the importance of medication adherence, we have few effective tools to help patients improve taking their medications. One strategy to improve medication adherence is using newer technology to make engagement with patients significantly easier and more immediate. These studies evaluating how best to use these technologies and engage different support providers (family/friends/or peers) to improve medication adherence.

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Authorizing Statute(s): None

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:
	79 FR 72248	12/05/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 44198	07/24/2015
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Evaluating Peer Notifications to Improve Statin Medication Adherence among Patients with Coronary Artery Disease	10-10139, 10-10139a, 10-10139b	Evaluating Individual and Patient-Selected Family/Friend/or Reciprocal Peer Notifications to Improve Statin Medication Adherence among Patients with Coronary Artery Disease ,   Evaluating Individual and Patient-Selected Family/Friend/or Reciprocal Peer Notification to Improve Statin Medication Adherence among Patients with Coronary Artery Disease ,   Evaluating Individual and Patient-Selected Family/Friend/or Reciprocal Peer Notification to Improve Statin Medication Adherence among Patients with Coronary Artery Disease

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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	224	0	0	224	0	0
Annual Time Burden (Hours)	784	0	0	784	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 ICR is new therefore all hours are an increase.

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Annual Cost to Federal Government: $0

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: 12/07/2015

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