Outcome Measure Repository

Forms and Documents

Document	Type	Status	Availability
Form 1 Attachment B: OMR Record (Data Collection Instrument)	Form and Instruction	New	Available
attachment c - ropr privacy impact assessment.docx	Supplementary Document	Uploaded 2018-04-19	Available
OMR_Supporting Statement Part A_04-25-18.docx	Supporting Statement A	Uploaded 2018-04-25	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
231141	Attachment B: OMR Record (Data Collection Instrument)	Form and Instruction	New

ICR Details

OMB Control No: 0935-0241	ICR Reference No: 201804-0935-001
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/AHRQ	Agency Tracking No:
Title: Outcome Measure Repository
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 without change	Conclusion Date: 06/29/2018
	Date Received in OIRA: 04/25/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2021	36 Months From Approved
Responses	70	0	0
Time Burden (Hours)	19	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: In line with the organization’s goals, AHRQ has developed the Registry of Patient Registries (RoPR). By providing a centralized point of collection for information about all patient registries in the United States, the RoPR furthers AHRQ’s goals by enhancing patient registry information, extracted from ClinicalTrials.gov or modeled based on the ClinicalTrials.gov data elements, to further describe the quality, appropriateness, and effectiveness of health services (and patient registries in particular) in a more readily available, central location. AHRQ is now proposing the development of the Outcome Measure Repository (OMR), a web-based database intended to house detailed information about outcome measures currently used in patient registries. This system will be linked to RoPR in two key ways. First, users entering registry information in the RoPR system will be able to associate OMR measure records with the RoPR registry records. Second, measure stewards listing a measure record in the OMR system will be able to associate the measure with an existing RoPR patient registry. Users will be able to access both databases with a single account (i.e., users with a RoPR account will be able to log in/access the OMR using that account, and vice versa). The OMR database system aims to achieve the following objectives: 1) Provide a searchable database of outcome measures used in patient registries in the United States (to promote collaboration, reduce redundancy, and improve transparency); 2) Facilitate the use of standardized data elements and outcome measures; 3) Facilitate the identification of potential areas of harmonization; To achieve the three objectives of this project, the following data collections will be implemented: 1) Collect information on outcome measures and related sub-elements from measure stewards who populate the OMR database system.

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Authorizing Statute(s): US Code: 42 USC 299 Name of Law: Healthcare Research and Quality Act of 1999
  

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:
	83 FR 4053	01/29/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 16858	04/17/2018
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Attachment B: OMR Record (Data Collection Instrument)	1	OMR Data Collection Instrument

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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	70	0	0	70	0	0
Annual Time Burden (Hours)	19	0	0	19	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 is a new information collection request

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Annual Cost to Federal Government: $744,015

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: 04/25/2018

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