For HHS/OASH Consultation Process, Institutional Review Board (IRB) Records

ICR 202107-0990-004

OMB:

Federal Form Document

Forms and Documents
IC Document Collections
IC ID
Document
Title
Status
248565
New
ICR Details
202107-0990-004
Received in OIRA
HHS/HHSDM
For HHS/OASH Consultation Process, Institutional Review Board (IRB) Records
New collection (Request for a new OMB Control Number)   No
Regular 01/05/2022
  Requested Previously Approved
36 Months From Approved
10 0
10 0
0 0

The Office for Human Research Protections is requesting a new approval from the Office of Management and Budget of an Office for Human Research Protections (OHRP) requirement that Institutional Review Board records be submitted when an IRB or its institution request an HHS consultation process, for proposed research involving, respectively: (1) pregnant women, human fetuses or neonates; (2) prisoners; or, (3) children, as subjects that are not otherwise approvable by an IRB.

PL: Pub.L. 99 - 158 491(a) Name of Law: Protection of Human Subjects
  
None

Not associated with rulemaking

  86 FR 40860 07/29/2021
87 FR 462 01/05/2022
Yes

1
IC Title Form No. Form Name
Protection of Human Subjects

  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 10 0 0 10 0 0
Annual Time Burden (Hours) 10 0 0 10 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
New

$9,981
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.
01/05/2022


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