Online Submission Form for Supplemental Evidence and Data for Systematic Reviews for the Evidence-based Practice Center Program

Forms and Documents

Document Name	Status
Form 1 Website portal for Submission of Supplemental Evidence and Data for Systematic Reviews Form and Instruction	New
Attachment E -- Draft PIA.pdf Supplementary Document	2016-05-26
Supporting Statement Part A (2).docx Supporting Statement A	2016-05-26
Supporting Statement Part B .docx Supporting Statement B	2015-12-11
Attachment A -- DRUGS Industry Request Letter_V13_07212014.docx Supplementary Document	2015-12-11

IC Document Collections

IC ID	Document Title	Status
219252	Website portal for Submission of Supplemental Evidence and Data for Systematic Reviews Form and Instruction	New

ICR Details

OMB Control No: 0935-0231	ICR Reference No: 201512-0935-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/AHRQ	Agency Tracking No:
Title: Online Submission Form for Supplemental Evidence and Data for Systematic Reviews for the Evidence-based Practice Center Program
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 with change	Conclusion Date: 05/26/2016
	Date Received in OIRA: 12/14/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2019	36 Months From Approved
Responses	70	0	0
Time Burden (Hours)	18	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This is a new activity of AHRQ’s Evidence-based Practice Center (EPC) Program. AHRQ’s EPC Program develops evidence reports and technology assessments on topics relevant to clinical and other health care organization and delivery issues—specifically those that are common, expensive, and/or significant for the Medicare and Medicaid populations. For example recent reviews have focused on clinical conditions, such as “Treatment of Nonmetastatic Muscle-Invasive Bladder Cancer” ; health delivery topics such as “Management Strategies to Reduce Psychiatric Admissions” ; and specific technologies such as “Imaging Techniques for Treatment Evaluation for Metastatic Breast Cancer.” These evidence reports include systematic reviews and technical briefs, and provide an essential foundation from which to understand what we know from existing research and what critical research gaps remain. These reports, reviews, and technology assessments are based on rigorous, comprehensive syntheses and analyses of the scientific literature on topics. EPC reports and assessments emphasize explicit and detailed documentation of methods, rationale, and assumptions. EPC reports are conducted in accordance with an established policy on financial and nonfinancial interests. These scientific syntheses may include meta-analyses and cost analyses. The EPC Program supports AHRQ’s mission by synthesizing and disseminating the available research as a “science partner” with private and public organizations in their efforts to improve the quality, effectiveness, and appropriateness of health care. The EPC Program is a trusted source of rigorous, comprehensive, and unbiased evidence reviews for stakeholders. The resulting evidence reports and technology assessments are used by Federal and State agencies, private-sector professional societies, health delivery systems, providers, payers, and others committed to evidence-based health care. These end-users may use EPC Program evidence reports to inform policy decisions, clinical practice guidelines, and other healthcare decisions.

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Authorizing Statute(s): US Code: 42 USC Sec. 299 Name of Law: Healthcare and Research 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 56989	09/21/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 76990	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: 1

IC Title	Form No.	Form Name
Website portal for Submission of Supplemental Evidence and Data for Systematic Reviews	1, 2	Attachment B -- Website portal for Submission of Supplemental Evidence and Data for Systematic Reviews ,   Attachment C – Optional Data Entry Form

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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)	18	0	0	18	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 collection.

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Annual Cost to Federal Government: $10,500

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: 12/14/2015

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