Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical Holds

ICR 200307-0910-004

OMB: 0910-0445

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0445 200307-0910-004
Historical Active 200006-0910-003
HHS/FDA
Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical Holds
Extension without change of a currently approved collection   No
Regular
Approved with change 12/03/2003
Retrieve Notice of Action (NOA) 07/25/2003
Approved consistent with the inclusion of a burden statement as an addendum to the guidance document.
  Inventory as of this Action Requested Previously Approved
12/31/2006 12/31/2006 12/31/2003
164 0 182
46,576 0 51,688
0 0 0

Guidance to assist sponsors in submitting responses to clinical holds so that they may be identified as complete responses and the agency can track the time to respond.

None
None


No

1
IC Title Form No. Form Name
Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical Holds

  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 164 182 0 -18 0 0
Annual Time Burden (Hours) 46,576 51,688 0 -5,112 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
Yes

$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.
07/25/2003


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