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

Forms and Documents

Document	Type	Status	Availability
Form 1 Website portal for Submission of Supplemental Evidence and Data for Systematic Reviews	Form and Instruction	Modified	Available
Jean Public Comment.msg	Supplementary Document	Uploaded 2019-06-24	Available
Attachment E -- Draft PIA.pdf	Supplementary Document	Uploaded 2016-05-26	Available
Supporting Statement Part A Comments 8.26 clean.docx	Supporting Statement A	Uploaded 2019-09-06	Available
Supporting Statement Part B jb.docx	Supporting Statement B	Uploaded 2019-06-24	Available
Attachment A -- Opportunity to Submit Scientific Information E-mail 6.11.._ (004).pdf	Supplementary Document	Uploaded 2019-09-06	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
219252	Website portal for Submission of Supplemental Evidence and Data for Systematic Reviews	Form and Instruction	Modified

ICR Details

OMB Control No: 0935-0231	ICR Reference No: 201906-0935-001
Status: Active	Previous ICR Reference No: 201512-0935-002
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: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 09/10/2019
	Date Received in OIRA: 06/26/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2022	36 Months From Approved
Responses	5	0	0
Time Burden (Hours)	1	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: 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:
	84 FR 12254	04/01/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 26684	06/07/2019
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
Website portal for Submission of Supplemental Evidence and Data for Systematic Reviews	1	Attachment B -- Website portal for Submission of Supplemental Evidence and Data for Systematic Reviews

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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	5	0	0	-65	0	70
Annual Time Burden (Hours)	1	0	0	-17	0	18
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Each SEADS request is a new collection. The burden is lower as we expect fewer responses. The nature of systematic reviews is to secure comparable evidence on the efficacy and effectiveness of numerous treatments for health related diseases and disorders. These reviews aim to inform healthcare decision making by clinicians and consumers, and inform guidance on clinical practice. The findings of these reviews are intended to help clinicians and consumers make the best decisions in their particular circumstances. In general, the goal for these reports is to be completed within a year. The steps that go into each review therefore are on a tight schedule and are not ongoing in order to fulfill their purpose. Thus, there are no ongoing collections of information from study sponsors and industry stakeholders for the same topic.

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Annual Cost to Federal Government: $1,168

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: 06/26/2019

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