American Recovery and Reinvestment Act "Developing a Registry of Registries"

Forms and Documents

Document Name	Status
Form Form #2 Review/update RoPR Record Form and Instruction	Modified
Form Form #1 New RoPR Record Form and Instruction	Modified
Attachment C - Impact Assessment_2016_January.docx Supplementary Document	2016-03-11
Supporting Statement Part B October 2015 - DRAFT - MS Edits.doc Supporting Statement B	2015-12-08
ROPR_SS Part A OMB.docx Supporting Statement A	2016-03-11

IC Document Collections

IC ID	Document Title	Status
203258	Review/update RoPR Record Form and Instruction	Modified
203257	New RoPR Record Form and Instruction	Modified

ICR Details

OMB Control No: 0935-0203	ICR Reference No: 201512-0935-001
Status: Historical Active	Previous ICR Reference No: 201207-0935-001
Agency/Subagency: HHS/AHRQ	Agency Tracking No:
Title: American Recovery and Reinvestment Act "Developing a Registry of Registries"
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 03/11/2016
	Date Received in OIRA: 12/14/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2019	36 Months From Approved
Responses	138	0	0
Time Burden (Hours)	64	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: By creating a central point of collection for information about all patient registries in the United States, the Registry of Patient Registries (RoPR) helps to further AHRQ's goals by making information regarding quality, appropriateness, and effectiveness of health services (and patient registries in particular) more readily available and centralized.

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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:
	80 FR 56992	09/21/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 76989	12/11/2015
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Review/update RoPR Record	Form #2	RoPR Data Collection Instrument
New RoPR Record	Form #1	RoPR 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	138	0	0	138	0	0
Annual Time Burden (Hours)	64	0	0	64	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 an ongoing collection of information. While user participation burden remains voluntary and minimal, with continued marketing of the RoPR as knowledge repository for patient registries, it is anticipated that the number of respondents will increase over time. The total burden hours, however, will remain the same as previously stated in Exhibit 2.

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Annual Cost to Federal Government: $129,124

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]? 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)? Yes

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: 12/14/2015

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