Supporting Statement for 0990-0278 FWA Form_June 2023

U. S. Department of Health and Human Services (HHS)
Office for Human Research Protections
Federalwide Assurance (FWA) Form
Supporting Statement

Background
The Office of the Assistant Secretary for Health, Office for Human Research Protections
(OHRP) is requesting a three-year extension of the OMB No. 0990-0278, Federalwide Assurance
(FWA) Form, with no changes in the collected information. The form is currently approved
through August 31, 2023. 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.
A.

Justification
1. Need and Legal Basis
Section 491(a) of the PHS Act states that the Secretary shall by regulation require that
each entity applying for HHS support to conduct research involving human subjects
submit to HHS “assurances” satisfactory to the Secretary that it has established an
institutional review board (IRB) to review the research in order to protect the rights of
the human subjects of such research.
Pursuant to the requirements of the PHS Act, HHS has promulgated regulations for
the protection of human subjects at 45 CFR part 46 1. These regulations require that
each institution engaged in research which is covered by the regulations and which is
conducted or supported by HHS provide written assurance satisfactory to the
Secretary that it will comply with the requirements set forth in the regulations
[45 CFR 46.103(a)]. In lieu of requiring submission of an assurance, each of the
other departments and agencies that follow the Federal Policy for the Protection of
Human Subjects (the Common Rule) shall accept the existence of a current assurance,
appropriate for the research in question, on file with, and approved for Federalwide
use by, the Office for Human Research Protections (OHRP)
[45 CFR 46.103(a)].
The assurance must be executed by an individual authorized to act for the institution
and to assume on behalf of the institution the obligations imposed by the HHS
regulations, and must be filed in such form and manner as the Secretary prescribes

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The pre-2018 HHS Protection of Human Subjects Regulations (or pre-2018 Requirements), codified at subpart A,
45 CFR part 46 (as amended), were originally promulgated in 1991 (56 FR 28012, 28022) and amended on June 23,
2005 (70 FR 36325). The 2018 HHS Protection of Human Subjects Regulations (or 2018 Requirements), codified at
subpart A, 45 CFR part 46 (as amended), were originally published on January 19, 2017 (82 FR 7149), and amended
on January 22, 2018 (83 FR 2885) and June 19, 2018 (83 FR 28497).

[45 CFR 46.103(c), pre-2018 Requirements; 45 CFR 46.103(b), 2018 Requirements].
OHRP is the HHS component charged with fulfilling the statutory mandates of these
provisions of the PHS Act and enforcing HHS regulations at 45 CFR part 46.
Currently the FWA is the only type of assurance OHRP accepts or approves.
OHRP anticipates that some respondents for this information collection are
institutions that are engaged in nonexempt HHS-conducted or –supported human
subjects research covered by two versions of the Common Rule: the pre-2018
Requirements and the 2018 Requirements. For example: some institutions are
engaged in research that was initially approved by an IRB before January 21, 2019,
(the general compliance date for the 2018 Requirements), and that research is covered
by the pre-2018 Requirements. January 21, 2019, was the general compliance date
for the 2018 Requirements. If those institutions are also engaged in some research
that was initially approved by an IRB on or after January 21, 2019, then that research
is covered by the 2018 Requirements.
The requirements for an assurance to include a statement of ethical principles and to
designate an IRB are included in what is referred to in this document as the pre-2018
version of subpart A of 45 CFR part 46 (the “pre-2018 Requirements”). The current
request for reinstatement of the FWA form OMB No. 0990-0278 does not include
modifications. While the 2018 Requirements do not include the requirements that
appear in the pre-2018 rule that assurances include a statement of the principles that
govern how the institution fulfills human research protections responsibilities for
research regardless of the source of support for the research, and designation of one
or more IRBs that review research to which the assurance applies, OHRP is seeking
to renew this information collection without changes, because the software
applications OHRP uses to manage the FWA application process must first be
modified to enable such changes. OHRP is seeking this renewal to permit continuity
while pursuing the appropriate software upgrades.
The renewal also continues to allow 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 an institution’s nonexempt human subjects
research regardless of the source of support (frequently referred to as “checking the
box”). If an institution “checks the box” on the FWA form it submits to OHRP,
OHRP may exercise compliance oversight authority over research in which that
institution is engaged and that is covered by the institution’s FWA, even if the
research is not conducted or supported by HHS.
OHRP plans to remove the option to “check the box,” but has chosen to retain the
“check the box” option until at least a 5-year period has elapsed since the general
compliance date of the 2018 Requirements. This means that the “check the box”
option would be removed no earlier than January 21, 2024.
OHRP’s choice to maintain the optional “check the box” aspect of the FWA form at
least until January 21, 2024, is in response to concerns received from the regulated
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community. These individuals expressed concerns unique to specific States, if the
FWA form no longer includes the “check the box” option. In order to give
institutions in these states additional time to accommodate this change, OHRP has
chosen to retain the “check the box” option in the current request for reinstatement of
the FWA form.
2. Information Users
The FWA collects the following information for the following purposes:
(a) The legal name, location and the current OHRP-approved assurance number
(if the institution already has an FWA) of the institution filing the FWA.
Purpose: OHRP uses this information to identify the specific institution to
which the FWA will apply. OHRP will make available the names and
locations of institutions holding an approved FWA to all components of HHS
that support research involving human subjects so that these components can
confirm that a particular institution holds an approved assurance satisfactory
to the Secretary before using HHS funds to support nonexempt human
subjects research.
(b) A list of components over which the institution submitting the FWA has legal
authority that operate under a different name; and any alternate names under
which the institution operates.
Purpose: Sec 2 (a) above
(c) A checkbox indicating the statement of principles (Belmont Report,
Declaration of Helsinki, or other) that govern the institution in the discharge
of its responsibilities for protecting the rights and welfare of human subjects
of research conducted at or sponsored by the institution, regardless of whether
the research is subject to Federal regulation. When only the “Other” box is
checked, the institution is asked to submit a copy of the statement of
principles with the FWA form.
Purpose: This information is collected so that OHRP can confirm that the
assurance satisfies the requirements of HHS regulations at
45 CFR 46.103(b)(1), pre-2018 Requirements.
(d) An optional checkbox which allows U.S. institutions to elect voluntarily to
apply either 45 CFR part 46 and all its subparts, or just 45 CFR part 46,
subpart A to all of its research regardless of the source of support for the
research.
Purpose: OHRP uses this information to define precisely the applicability of
the FWA.
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(e) For the FWA of International (Non-U.S.) Institutions, a checkbox is to be
completed indicating the procedural standards that the institution will apply to
its U.S. federally supported research, in addition to the Common Rule.
Purpose: OHRP obtains this information in order to be informed of whether
an international institution applies another procedural standard to the conduct
of U.S. federally supported research, in addition to the Common Rule.
(f) A list of internal IRBs, by name and registration number, that an institution
will rely upon to review the research to which the FWA applies; or, if the
institution has no internal IRB the external IRB, by name and registration
number that the institution will rely upon, or if only multiple external IRBs are
relied upon, the name and registration number of the external IRB that
reviews the largest percentage of research to which the FWA applies.
Purpose: This information is collected so that OHRP can confirm that the
assurance satisfies the requirements of HHS regulations at
45 CFR 46.103(b)(2), pre-2018 Requirements.
(g) The name, degree(s) or suffix, institutional title, address, telephone number,
facsimile number, and e-mail address of the Human Protections Administrator
(i.e., the person who can serve as primary point of contact for the institution’s
system for protecting human subjects).
Purpose: This information is collected so that OHRP has a central point of
contact at the institution for questions and issues related to the FWA and the
institution’s procedures for protecting human subjects. The information can
be used by OHRP to disseminate important information and announcements
related to human subject protections issues and provides a means for
enhancing communication between OHRP and institutions engaged in
research conducted or supported by HHS. The information also will facilitate
OHRP’s ability to conduct (i) its compliance oversight program that responds
to allegations or indications of noncompliance with the HHS regulations at 45
CFR part 46 and the terms of the assurance; and (ii) its education program for
providing clarification and guidance concerning ethical issues related to
human subjects research.
(h) The name, degree(s) or suffix, institutional title, address, telephone number,
facsimile number, and e-mail address of the Signatory Official (i.e., the
official legally authorized to represent the institution). The Signatory Official
must assure that human subjects research to which the FWA applies is
conducted in accordance with the terms of assurance and sign and date the
FWA. The Signatory Official must electronically sign the FWA using the
electronic submission system available through the OHRP Web site at
http://ohrp.cit.nih.gov/efile/, unless the institution lacks the ability to submit
its FWA electronically.
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Purpose: This information is collected so that OHRP can confirm that the
assurance satisfies the requirements of HHS regulations at 45 CFR 46.103(c),
pre-2018 Requirements/45 CFR 46.103(b), 2018 Requirements. The
information can be used by OHRP to disseminate important information and
announcements related to human subject protections issues and to provide a
means for enhancing communication between OHRP and institutions engaged
in research conducted or supported by HHS. The information also will
facilitate OHRP’s ability to conduct (i) its compliance oversight program that
responds to allegations or indications of noncompliance with the HHS
regulations at 45 CFR part 46 and the terms of the assurance; and (ii) its
education program for providing clarification and guidance concerning ethical
issues related to human subjects research.
OHRP will make available information collected in the FWA to the other Federal
departments and agencies that have adopted the Common Rule. This will enable
these departments and agencies to confirm that a particular institution holds an
applicable assurance approved for Federalwide use. The other Federal departments
and agencies will also be able to use this information to contact appropriate
institutional officials for questions and issues related to the human subjects research
conducted or supported by these departments and agencies at the institution.
OHRP provides two supplemental sample forms that may be used by institutions
submitting or holding FWAs, but which are not collected routinely by OHRP. The
first form is an IRB Authorization Agreement. When an institution holding an
OHRP-approved FWA relies upon an IRB operated by another organization or
institution to review HHS-conducted research, the FWA-holding institution must
document its reliance on the IRB for oversight of the research. The FWA-holding
institution maintains this documentation, which is to be made available to OHRP
upon request. The FWA-holding institution may, but need not, use OHRP’s IRB
Authorization Agreement to document its reliance.
The second supplemental form is an Individual Investigator Agreement. An
institution with an approved FWA may use this form to extend the applicability of the
FWA to individual investigators who are not otherwise employees or agents of an
assured institution. The form defines in writing the circumstances under which the
collaborating investigator is covered by the institution’s FWA. The purpose of the
form is to provide a simplified mechanism that allows an institution with an FWA to
extend the applicability of its FWA to cover collaborating investigators, in lieu of
OHRP requiring that such collaborating investigators’ non-assured institution submit
a separate FWA. The form is kept on file by the FWA institution and is to be made
available to OHRP upon request. Institutions are free to modify the form or develop
their own form to cover a collaborating individual investigator.
3. Improved Information Technology
Institutions submitting a FWA will electronically submit all information for initial
FWAs, or updates and renewals of existing FWAs, including the signature of the
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Signatory Official, via the internet using an interactive page on the OHRP website.
OHRP has the technology that permits OHRP to accept electronic signatures of
Signatory Officials for the FWA. This eliminates the need for submission of any
paperwork, except for rare institutions that lack the ability to submit their FWAs
electronically. Between January 1, 2021, and December 31, 2021, 3,403 FWAs were
submitted to OHRP for approval and all were submitted electronically. OHRP
anticipates that virtually all institutions will continue to submit FWA information
electronically via the internet.
4. Duplication of Similar Information
The FWA does not duplicate any other information collection by OHRP.
5. Small Businesses
The information collected through the FWA represents the minimum amount of
information necessary to satisfy the assurance requirements of the PHS Act and HHS
regulations at 45 CFR 46.103. The information collection will not have a significant
economic impact on a substantial number of small entities.
6. Less Frequent Collection
Institutions are required to update the FWA within 90 days after changes occur
regarding the legal name of the institution, the Human Protections Administrator or
the Signatory Official. Each institution must renew its FWA every 5 years, even if no
changes have occurred, in order to maintain an active FWA.
7. Special Circumstances
None.
8. Federal Register Notice/Outside Consultation
Public comments were solicited for a 60-day period in the Federal Register published
on April 14, 2023 (88 FR 23092). No comments were submitted.
9. Payment/Gift to Respondent
No payments or gifts are provided to the respondents.
10. Confidentiality
The information collected under the FWA in the past was considered releasable under
the Freedom of Information Act (FOIA). However, currently OHRP no longer
requires public requesters to submit a FOIA request in order to release non-public
FWA information.
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The database used to track FWA data, referred to as the Human Assurance Tracking
System (HATS), uses Microsoft SQL Server tables stored on a server that are
maintained by the Center for Information Technology, National Institutes of Health.
The HATS application screens and associated FWA tables/server utilize a
username/password and appropriate session variables to access and modify the FWA
data. Without the appropriate username/password, unauthorized users will not gain
access to the FWA database. FWA database tables will never be provided outside of
OHRP. Requests for FWA information are fulfilled via electronic or printed reports
or disks containing extracted information.
The public can retrieve some data from FWA database tables via the internet search
screens found on the OHRP website at
https://ohrp.cit.nih.gov/search/search.aspx?styp=bsc. This link provides read only
access to the name, location, and FWA assurance number of institutions holding an
active OHRP-approved FWA. Information provided to the public via the OHRP
website does not include the names and contact information of the FWA Signatory
Official or Human Protections Administrator identified in the FWA form. This
information is accessible to appropriate representatives of the other Federal
departments and agencies that have adopted the Common Rule via a secure internet
connection requiring a username and password. Members of the public may contact
OHRP to obtain this information. Of note, members of the public and other agencies’
representatives do not have the ability to modify the FWA database tables.
11. Sensitive Questions
No sensitive information is being collected by the FWA.
12. Estimates of Annualized Burden Hours and Costs
The estimate of the number of respondents is based upon the current (as of
11/29/2022) number of active OHRP-approved FWAs (13,829) and projecting that
the number may increase to 14,000.
The estimate of the number of responses per respondent is based upon the assumption
that an institution will need to submit an initial FWA, or update or renew a previously
approved FWA, on average every six months.
The estimate of the hours per response assumes that virtually all respondents will
complete the FWA form via the internet on an interactive page on the OHRP website.
The time estimate includes an estimate of the time needed to (i) read and understand
the instructions for completing the FWA; (ii) read and understand the FWA terms of
assurance; and (iii) enter the information requested on the FWA form. The estimate
assumes that completing a new FWA, or updating or renewing an existing FWA, on
average, will be completed in 0.50 hours.

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12a. Estimated Annualized Burden in Hours Table
Form name
Number of
Number of
Hours per
Respondents
Responses per Response
Respondent
Federalwide
14,000
2.0
30/60
Assurance
(FWA)
Total

Response
Burden Hours
14,000

14,000

OHRP estimates an average submitter’s hourly wage rate of $40 per hour (for
institutional officials, administrators, administrative staff). The total annual costs for
reading and understanding instructions and terms of assurance and entering the
information via the internet are estimated to be 14,000 burden hours X $40/hour =
$560,000.
12b. Estimated Burden Costs Table
Form name
Number of
Burden Hours Hourly
Respondents
Wage
Federalwide
Assurance
(FWA)
Total

14,000

14,000

$40.00

Total
Respondent
Cost
$560,000

$560,000

13. Capital Costs (Maintenance of Capital Costs)
There are no direct capital costs to respondents other than the time to review the
Terms of Assurance and to complete the FWA form.
14. Cost to Federal Government
The estimated annual Federal Government cost is $220,935: $145,935 for reviewing
and approving FWAs and $75,000 for operating, managing and hosting the database.
15. Program or Burden Changes
The annual burden will continue to be 14,000 hours. There is no program or
adjustment change.
16. Publication and Tabulation Dates
Information on institutions that hold an approved FWA, is available on the OHRP
website.

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17. Expiration Date
OHRP is not seeking approval to not show the expiration date.
18. Exception to Certification for Paperwork Reduction Act Submissions
No certification exception is requested.
B. Justification of Information Employing Statistical Methods
Not Applicable

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LIST OF ATTACHMENTS
Attachment 1 – Legal Authorities
a. Section 491 of the Public Health Service Act
b. Title 45 Code of Federal Regulations Part 46 (pre-2018 Requirements)
c. Title 45 Code of Federal Regulations Part 46 (2018 Requirements)
Attachment 2 – FWA Terms of Assurance
Attachment 3 – FWA Form
Attachment 4 – Instructions for completing the FWA form
Attachment 5 – Supplemental sample forms
a. IRB Authorization Agreement
b. Individual Investigator Agreement

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