Institutional Review Board Registration Form

ICR 202205-0990-005

OMB: 0990-0279

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2022-05-20
Supplementary Document
2018-10-25
Supplementary Document
2018-08-17
Supplementary Document
2018-08-16
Supplementary Document
2018-08-16
Supplementary Document
2018-08-16
Supplementary Document
2018-08-16
Supplementary Document
2018-08-16
IC Document Collections
IC ID
Document
Title
Status
218331
Modified
218328 Modified
ICR Details
0990-0279 202205-0990-005
Received in OIRA 201808-0990-002
HHS/HHSDM
Institutional Review Board Registration Form
Reinstatement without change of a previously approved collection   No
Regular 05/24/2022
  Requested Previously Approved
36 Months From Approved
12,000 0
6,175 0
0 0

The respondents for this collection are institutions or organizations operating IRBs that review human subjects research conducted or supported by HHS, or, in the case of FDA's regulation, each IRB in the United States that reviews clinical investigations regulated by FDA under sections 505(i) or 520(g) of the Federal Food, Drug and Cosmetic Act; and each IRB in the United States that reviews clinical investigations that are intended to support applications for research or marketing permits for FDA-regulated products.

PL: Pub.L. 115 - 180 289 Name of Law: Public Health Service Act
  
None

Not associated with rulemaking

  87 FR 8853 02/16/2022
87 FR 31569 05/24/2022
No

2
IC Title Form No. Form Name
Institutional Review Board (IRB) Registration form
new registrations

  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 12,000 0 0 0 0 12,000
Annual Time Burden (Hours) 6,175 0 0 0 0 6,175
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$353,000
No
    No
    No
No
No
No
No
Irene Stith-Coleman 240 453-8138 irene.stith-coleman@hhs.gov

  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.
05/24/2022


© 2024 OMB.report | Privacy Policy