Federalwide Assurance (FWA)

Forms and Documents

Document Name	Status
Form 0990-0278 Federalwide Assurance (FWA) Form	Modified
30-Day Notice_0990-0278_ 90 FR 25058_ 13Jun2025.pdf Supplementary Document	2025-06-13
60-Day FRN_89 FR 91413_Tuesday 19Nov24.pdf Supplementary Document	2025-05-30
FWA Instructions.docx Supplementary Document	2025-05-30
FWA Terms.docx Supplementary Document	2025-05-30
FWA Form.docx Supplementary Document	2025-05-30
Supporting Statement A_Federalwide Assurance.docx Supporting Statement A	2025-06-04
45 CFR part 46 Regulations_2018 Requirements.pdf Supplementary Document	2023-04-13
45 CFR part 46 Regulations_Pre-2018 Requirements.pdf Supplementary Document	2023-04-13
Individual Investigator Agreement.pdf Supplementary Document	2023-04-13
IRB Authorization Agreement.pdf Supplementary Document	2023-04-13

IC Document Collections

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

ICR Details

OMB Control No: 0990-0278	ICR Reference No: 202501-0990-001
Status: Received in OIRA	Previous ICR Reference No: 202304-0990-009
Agency/Subagency: HHS/HHSDM	Agency Tracking No:
Title: Federalwide Assurance (FWA)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 06/16/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	10/31/2026
Responses	13,000	28,000
Time Burden (Hours)	4,290	14,000
Cost Burden (Dollars)	0	0

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Abstract: The Office of the Assistant Secretary for Health, Office for Human Research Protections (OHRP) is requesting a revision of the currently approved collection for the OMB No. 0990-0278, Federalwide Assurance (FWA) Form. The form is currently approved through October 31, 2026. The purpose of the FWA form 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 information collection are institutions engaged in HHS-conducted or –supported research involving human subjects. With this revision, OHRP is seeking to remove information from the FWA form to adopt the changes at 45 CFR 46.103 of the 2018 Requirements and reduce burden on respondents. The proposed changes to the FWA form include: 1) removing the Pre-2018 Common Rule requirement that institutions provide a statement of ethical principles; 2) removing the Pre-2018 Common Rule requirement that an institution designate one or more IRBs to review the research to which the FWA applies; 3) removing “check the box”, or the option for U.S. institutions to voluntarily apply the Common Rule, or the Common Rule and subparts B, C, and D of the HHS regulations at 45 CFR part 46, to all of an institution’s nonexempt human subjects research regardless of the source of support; and 4) eliminating the requirement for institutions outside the U.S. to provide procedural standards they apply for human subjects research when assuring compliance with the Terms of the Federalwide Assurance. Updates to the software applications OHRP uses to manage the FWA application process will be deployed to enable such changes.

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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:
	89 FR 91413	11/19/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 25058	06/13/2025
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
Federalwide Assurance (FWA)	0990-0278	Federalwide Assurance (FWA)

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ICR Summary of Burden

	Total Request	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	13,000	28,000	0	-15,000	0	0
Annual Time Burden (Hours)	4,290	14,000	0	-9,710	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The burden calculation has been adjusted accounting for the number of institutions that hold active FWAs, average responses per institutional annually, and the time required to complete an application. We estimate that there will be an average of 1 FWA application submission per institution annually (13,000 x 1 = 13,000) and that each application will require 20 minutes to complete, accounting for the estimated 4,290 response burden hours. This represents a decrease in annual burden hours of 9,710 hours compared to the previously approved burden. The change accounts for: 1) implementation of the 2018 Requirements burden reducing changes to the FWA, which provides a simplified, shorter application process for respondents; and 2) the fact that there are approximately 1,000 fewer institutions that hold an active FWA compared to the previously approved information collection period.

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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: 06/16/2025

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