Research Study Complaint Form

ICR 200512-0910-005

OMB: 0910-0579

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
6302
Migrated
ICR Details
0910-0579 200512-0910-005
Historical Active
HHS/FDA
Research Study Complaint Form
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 03/10/2006
Retrieve Notice of Action (NOA) 12/22/2005
We encourage CDER to work with the other centers in FDA to develop a common form so that research study complaints for all FDA regulated products can be submitted through a single portal. FDA shall provide OMB an update on the progress of the common form before the submission of the request for extension of this collection.
  Inventory as of this Action Requested Previously Approved
03/31/2009 03/31/2009
144 0 0
144 0 0
0 0 0

The complaint form transmits to FDA public complaints concerning misconduct in research studies.

None
None


No

1
IC Title Form No. Form Name
Research Study Complaint 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 144 0 0 144 0 0
Annual Time Burden (Hours) 144 0 0 144 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  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.
12/22/2005


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