Federalwide Assurance (FWA)

Forms and Documents

Document Name	Status
Form 0990-0978 Federalwide Assurance (FWA) Form	Modified
Supporting Statement_FWA 0990-0278_30-Day PRA _07.23.2020.pdf Supporting Statement A	2020-07-24
45 CFR part 46 Regulations.pdf Supplementary Document	2020-04-22
Individual Investigator Agreement Sample.pdf Supplementary Document	2020-04-22
IRB Authorization Agreement Sample .pdf Supplementary Document	2020-04-22
Terms of the FWA.pdf Supplementary Document	2020-04-22
FWA Form Instructions .pdf Supplementary Document	2020-04-22

IC Document Collections

IC ID	Document Title	Status
10411	Federalwide Assurance (FWA) Form	Modified

ICR Details

OMB Control No: 0990-0278	ICR Reference No: 202004-0990-006
Status: Active	Previous ICR Reference No: 201702-0990-003
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: 08/25/2020
	Date Received in OIRA: 07/24/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2023	36 Months From Approved	08/31/2020
Responses	28,000	0	28,000
Time Burden (Hours)	14,000	0	14,000
Cost Burden (Dollars)	0	0	0

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Abstract: The Office for Human Research Protections (OHRP) is requesting a three-year extension of the OMB No. 0990-0278, Federalwide Assurance (FWA) for the Protection of Human Subjects Form, currently approved through July 31, 2020, with no changes in the collected information. The purpose of the FWA is to provide a simplified procedure for institutions engaged in research conducted or supported by the Department of Health and Human Services (HHS) to satisfy the assurance requirements of (1) Section 491(a) of the Public Health Service Act (the PHS Act) (42 U.S.C. 289); and (2) HHS regulations for the protection of human subjects at 45 CFR 46.103. The respondents for this collection are research institutions engaged in HHS-conducted or –supported research involving human subjects.

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Authorizing Statute(s): US Code: 42 USC Section 289 Name of Law: Public Health Service Act
  

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:
	85 FR 23051	04/24/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 43858	07/20/2020
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)	0990-0978	FWA 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	28,000	28,000	0	0	0	0
Annual Time Burden (Hours)	14,000	14,000	0	0	0	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:

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Annual Cost to Federal Government: $400,000

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.     No

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? No

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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: 07/24/2020

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