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 âsupported 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 âcheck the boxâ, 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 institutionâs 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.
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.
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:
(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;
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.
Form 0990-0278 Federalwide Assurance (FWA)
PC_202501-0990-001_071425_045833_1.pdf
FWA Instructions.docx
Federalwide Assurance (FWA)