FDA Guidance for Industry on Continuous Marketing Applications: Pilot 2 - Scientific Feedback and Interactions During Develop- ment of Fast Track Products Under PDUFA

ICR 200308-0910-005

OMB: 0910-0518

Federal Form Document

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Document
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ICR Details
0910-0518 200308-0910-005
Historical Active
HHS/FDA
FDA Guidance for Industry on Continuous Marketing Applications: Pilot 2 - Scientific Feedback and Interactions During Develop- ment of Fast Track Products Under PDUFA
New collection (Request for a new OMB Control Number)   No
Emergency 09/10/2003
Approved with change 09/29/2003
Retrieve Notice of Action (NOA) 08/27/2003
This paperwork is approved on an emergency basis under the following condition: FDA will revise the guidance document to contain the PRA mandated disclosure statement including the collection's OMB number, expiration date and expected burden.
  Inventory as of this Action Requested Previously Approved
06/30/2004 06/30/2004
125 0 0
10,000 0 0
0 0 0

The guidance discusses how the agency will implement a pilot program for frequent scientific feedback and interactions between FDA and applicants during the investigational phase of development of certain Fast Track drug and biological products. Applicants are being asked to apply to participate in the Pilot program.

None
None


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 125 0 0 125 0 0
Annual Time Burden (Hours) 10,000 0 0 10,000 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.
08/27/2003


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