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.
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.