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OMB Control No: 0935-0241	ICR Reference No: 201804-0935-001
Status: Historical 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

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.

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

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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

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

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

ICR Summary of Burden

	Total Approved	Change Due to Agency Discretion
Annual Number of Responses	70	70
Annual Time Burden (Hours)	19	19
Annual Cost Burden (Dollars)	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

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

Agency Contact: Erwin Brown 301 427-1652 erwin.brown@ahrq.hhs.gov

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