Guidance for Industry: Fast Track Drug Development Programs - Designation, Development, and Application Review

ICR 200808-0910-003

OMB: 0910-0389

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2008-08-22
ICR Details
0910-0389 200808-0910-003
Historical Active 200506-0910-001
HHS/FDA
Guidance for Industry: Fast Track Drug Development Programs - Designation, Development, and Application Review
Extension without change of a currently approved collection   No
Regular
Approved without change 09/29/2008
Retrieve Notice of Action (NOA) 08/28/2008
  Inventory as of this Action Requested Previously Approved
09/30/2011 36 Months From Approved 09/30/2008
137 0 114
10,620 0 8,720
0 0 0

This guidance is intended to articulate how FDA plans to work with sponsors to achieve expedited development and rapid review of new drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs for the condition. The guidance also meets the requirements of section 112 of the Food and Drug Administration Modernization Act of 1997, which amended the Federal Food, Drug and Cosmetic Act (21 U.S.C. 351 et seq.) by adding new section 506 ("Fast Track Products").

US Code: 21 USC 301 Name of Law: FFDCA
  
None

Not associated with rulemaking

  73 FR 25016 05/06/2008
73 FR 50028 08/25/2008
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 137 114 0 0 23 0
Annual Time Burden (Hours) 10,620 8,720 0 0 1,900 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Eliazabeth Berbakos 3018271482

  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.
08/28/2008


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