Development of an Electronic System for Reporting Medication Errors and Adverse Drug Events in Primary Care Practice (MEADERS)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Supporting Statement Part B.doc	Supporting Statement B	Uploaded 0000-00-00	Repair queued
Attachment 4-- Questionnaire.pdf	Supplementary Document	Uploaded 0000-00-00	Repair queued
Attachment 3a -- Comments from Alan Goldhammer of Pharma.doc	Supplementary Document	Uploaded 0000-00-00	Repair queued
Attachment 3 -- Comments from B Sachau.doc	Supplementary Document	Uploaded 0000-00-00	Repair queued
Attachment 2.pdf	Supplementary Document	Uploaded 0000-00-00	Repair queued
Supporting Statement Part A.doc	Supporting Statement A	Uploaded 0000-00-00	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
179141	Development of an Electronic System for Reporting Medication Errors and Adverse Drug Events in Primary Care Practice (MEADERS)		New

ICR Details

OMB Control No:	ICR Reference No: 200703-0935-003
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/AHRQ	Agency Tracking No:
Title: Development of an Electronic System for Reporting Medication Errors and Adverse Drug Events in Primary Care Practice (MEADERS)
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OIRA Conclusion Action: Withdrawn	Conclusion Date: 06/29/2007
	Date Received in OIRA: 03/21/2007
Terms of Clearance: This ICR is being withdrawn as requested by AHRQ. Before resubmitting, AHRQ agrees to publish a second FRN and provide for a 30 day public comment period and will make sure that the ICR package provided to the public is complete. The supporting statement will also be updated to reflect AHRQ’s revised study design and clarify the purpose of this study. Prior to re-submission, AHRQ will consult with its general counsel to confirm whether AHRQ has the statutory authority to provide assurances of confidentiality that will, for example, stand up to FOIA requests. If not, all materials should be revised so that assurances of confidentiality are not provided to the public.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Development of an Electronic System for Reporting Medication Errors and Adverse Drug Events in Primary Care Practice (MEADERS) is being conducted in response to a modification of an AHRQ RFP entitled Resource Center for Primary Care Practice-Based Research Networks (PBRNs) (Issued under Contract 290-02-0008). The landmark Harvard Medical Practice Study was published in 1991 and stated that 98,000 Americans die each year from medical errors. Although the exact figure has been disputed, no one disputes the fact that too many Americans are injured unnecessarily by medical mistakes that could be avoided. Another study performed by the Department of Veterans Affairs suggests that in one out of every 10,000 hospitalizations, a patient dies due directly to a medical error.

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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:
	71 FR 74537	12/12/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 6731	02/13/2007
Did the Agency receive public comments on this ICR? Yes

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

table that charts list of burden

IC Title	Form No.	Form Name
Development of an Electronic System for Reporting Medication Errors and Adverse Drug Events in Primary Care Practice (MEADERS)

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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 is a new information collection.

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Annual Cost to Federal Government: $1,000,000

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]? 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)? Uncollected

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: 03/21/2007

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