Guidance for Industry: Continuous Marketing Applications: Pilot 2 Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA

ICR 200706-0910-005

OMB: 0910-0518

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2007-08-09
Supporting Statement A
2007-06-13
ICR Details
0910-0518 200706-0910-005
Historical Active 200402-0910-007
HHS/FDA
Guidance for Industry: Continuous Marketing Applications: Pilot 2 Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA
Extension without change of a currently approved collection   No
Regular
Approved with change 09/26/2007
Retrieve Notice of Action (NOA) 06/28/2007
OMB notes that previous terms of clearance mandated that, "FDA shall revise the guidance to display the OMB control number, expiration date and the burden statement." Based on the guidance document submitted as part of this package, OMB does not find these items displayed. As expeditiously as possible, FDA is to revise the guidance to comply with the previous terms of clearance and is to report to OMB when this is done.
  Inventory as of this Action Requested Previously Approved
09/30/2010 36 Months From Approved 09/30/2007
8 0 125
640 0 10,000
0 0 0

This 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 certain Fast Track drug and biological products. Applicants are being asked to apply to participate in the Pilot program.

US Code: 21 USC 355(a) Name of Law: Federal Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking

  71 FR 41819 08/24/2006
72 FR 28495 05/21/2007
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 8 125 0 0 -117 0
Annual Time Burden (Hours) 640 10,000 0 0 -9,360 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$16,000
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.
06/28/2007


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