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

ICR 200612-0910-003

OMB: 0910-0445

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2006-09-18
Supporting Statement A
2006-09-18
ICR Details
0910-0445 200612-0910-003
Historical Active 200307-0910-004
HHS/FDA
Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical Holds
Extension without change of a currently approved collection   No
Regular
Approved without change 01/29/2007
Retrieve Notice of Action (NOA) 12/13/2006
FDA will provide the PRA-mandated burden notice on the guidance document.
  Inventory as of this Action Requested Previously Approved
01/31/2010 36 Months From Approved 01/31/2007
180 0 164
51,120 0 46,576
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.

PL: Pub.L. 105 - 115 117 Name of Law: FDAMA
  
None

Not associated with rulemaking

  71 FR 30142 05/25/2006
71 FR 57972 10/02/2006
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 180 164 0 16 0 0
Annual Time Burden (Hours) 51,120 46,576 0 4,544 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
The change in burden estimates is based on more recent data reflecting the number of receipts.

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Saleda Perryman

  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.
12/04/2006


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