OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

Protection of Human Subjects: Informed Consent; Institutional Review Boards

ICR 201307-0910-006 · OMB 0910-0755 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
SUPPORTING STATEMENT IRB FINAL 11-26-13.doc Supporting Statement A Uploaded 2013-11-26 Available
IC Document Collections
IC IDCollectionTypeStatusForm
207945 Reinstatement of an IRB or Institution, 56.123 New
207944 IRB Response to Lesser Administrative Actions for Noncompliance, 56.120(a) New
207943 Suspension of Termination of IRB Approval of Research, 56.113 New
207942 Exception from Informed Consent for Emergency Research, 50.24 New
207941 IRB Written Notification to Approve or Disapprove Research, 56.109(e); Continuing Review, 56.109(f); Elements of Informed Consent (IC), 50.25; Documentation of IC, 50.27 New
ICR Details
0910-0755 201307-0910-006
Historical Active
HHS/FDA 20057
Protection of Human Subjects: Informed Consent; Institutional Review Boards
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 12/13/2013
Retrieve Notice of Action (NOA) 07/30/2013
  Inventory as of this Action Requested Previously Approved
12/31/2016 36 Months From Approved
246,021 0 0
243,070 0 0
0 0 0
This information collection request addresses limited collections of information not currently approved under an OMB control number for institutional review boards (IRBs) and clinical investigators involved with human subject research regulated by the Food and Drug Administration (FDA). IRBs are required to review for approval FDA-regulated research activities. Clinical investigators are required to obtain informed consent from research subjects participating in FDA-regulated clinical trials. These limited collections of information help protect the rights, safety, and welfare of human subjects who participate in research actitivies within FDA's jurisdiction.
US Code: 42 USC 262 Name of Law: PHS Act
  
None
Not associated with rulemaking
  78 FR 24208 04/24/2013
78 FR 44126 07/23/2013
No
  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 246,021 0 0 246,021 0 0
Annual Time Burden (Hours) 243,070 0 0 243,070 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new information collection request.
$0
No
No
No
No
No
Uncollected
ILa Mizrachi 301 796-7726 [email protected]
  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.
07/30/2013