Federalwide Assurance (FWA)

ICR 202004-0990-006

OMB: 0990-0278

Federal Form Document

Forms and Documents
Document
Name
Status
Form
Modified
Supporting Statement A
2020-07-24
Supplementary Document
2020-04-22
Supplementary Document
2020-04-22
Supplementary Document
2020-04-22
Supplementary Document
2020-04-22
Supplementary Document
2020-04-22
IC Document Collections
IC ID
Document
Title
Status
10411 Modified
ICR Details
0990-0278 202004-0990-006
Active 201702-0990-003
HHS/HHSDM
Federalwide Assurance (FWA)
Extension without change of a currently approved collection   No
Regular
Approved without change 08/25/2020
Retrieve Notice of Action (NOA) 07/24/2020
  Inventory as of this Action Requested Previously Approved
08/31/2023 36 Months From Approved 08/31/2020
28,000 0 28,000
14,000 0 14,000
0 0 0

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.

US Code: 42 USC Section 289 Name of Law: Public Health Service Act
  
None

Not associated with rulemaking

  85 FR 23051 04/24/2020
85 FR 43858 07/20/2020
No

1
IC Title Form No. Form Name
Federalwide Assurance (FWA) 0990-0978 FWA Form

  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
No
No

$400,000
No
    No
    No
No
No
No
No
Sherette Funn-Coleman

  No

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.
07/24/2020


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