Federalwide Assurance (FWA)

Forms and Documents

Document Name	Status
Instructions for the Federalwide Assurance _0990-0278_08 May 2017.doc Supplementary Document	2017-06-07
Terms of the Federalwide Assurance _0990-0278_05 May 2017.doc Supplementary Document	2017-06-07
0990-0278 IRB Authorization Agreement Sample for the Federalwide Assurance PRA _Su....rtf Supplementary Document	2017-06-07
0990-0278 Individual Investigator Agreement Sample for FWA PRA - Supplemental Info....docx Supplementary Document	2017-06-07
Regulations_45 CFR part 46_for Federalwide Assurance PRA 30_Day_to Toni_....pdf Supplementary Document	2017-06-07
30 day Federal Register, Volume 82 Issue 107 (Tuesday, June 6, 2017).htm Supplementary Document	2017-06-07
60-day Federal Register, Volume 82 Issue 42 (Monday, March 6, 2017).htm Supplementary Document	2017-06-07
Supporting Statement for the Federalwide Assurance Form 0990-0278 to Res....doc Supporting Statement A	2017-06-07

IC Document Collections

IC ID	Document Title	Status
10411	Federalwide Assurance (FWA) Other-survey	Modified

ICR Details

OMB Control No: 0990-0278	ICR Reference No: 201702-0990-003
Status: Historical Active	Previous ICR Reference No: 201404-0990-003
Agency/Subagency: HHS/HHSDM	Agency Tracking No:
Title: Federalwide Assurance (FWA)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/19/2017
	Date Received in OIRA: 06/07/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2020	36 Months From Approved	08/31/2017
Responses	28,000	0	22,100
Time Burden (Hours)	14,000	0	11,050
Cost Burden (Dollars)	0	0	0

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Abstract: The FWA is designed to provide a simplified procedure for institutions engaged in HHS-conducted or supported research to satisfy the assurance requirements of Section 491(a) of the Public Health Service Act and of HHS regulations for the protection of human subjects at 45 CFR 46.103. The respondents are institutions engaged in human subjects research conducted or supported by HHS.

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Authorizing Statute(s): PL: Pub.L. 99 - 158 491 Name of Law: Institutional Review Boards;Ethics Guidance Program
  

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:
	82 FR 12615	03/06/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 26108	06/06/2017
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
Federalwide Assurance (FWA)

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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	28,000	22,100	0	0	5,900	0
Annual Time Burden (Hours)	14,000	11,050	0	0	2,950	0
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: No

Burden Reduction Due to:

Short Statement: The annual burden will increase by 2950 from 11,050 hours to 14,000. We anticipate that respondents will increase by 5900 from 22100 to 28000 due to the need for more respondents to obtain a FWA.

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Annual Cost to Federal Government: $400,000

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: 06/07/2017

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