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

ICR 201412-0910-016

OMB: 0910-0389

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2014-12-29
IC Document Collections
IC ID
Document
Title
Status
6040 Modified
186322 Modified
ICR Details
0910-0389 201412-0910-016
Historical Active 201108-0910-002
HHS/FDA CDER
Guidance for Industry: Fast Track Drug Development Programs - Designation, Development, and Application Review
Extension without change of a currently approved collection   No
Regular
Approved with change 02/09/2015
Retrieve Notice of Action (NOA) 12/30/2014
  Inventory as of this Action Requested Previously Approved
02/28/2018 36 Months From Approved 02/28/2015
203 0 195
15,700 0 14,780
0 0 0

The guidance describes how FDA plans to work with applicants and sponsors to achieve expedited development and rapid review of new drugs or biological products intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs for the condition. A sponsor or applicant seeking to have a drug or biological product designated as one in a fast track drug development program may submit a request for fast track designation as an amendment to an IND or as a supplement to an application. After FDA makes a fast track designation, the sponsor or applicant may submit a pre-meeting package which may include additional information supporting a request to participate in certain fast track programs.

US Code: 21 USC 356 Name of Law: FD&C Act
  
None

Not associated with rulemaking

  79 FR 44780 09/30/2014
79 FR 75564 12/18/2014
No

2
IC Title Form No. Form Name
Designation Requests
Premeeting Packages

  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 203 195 0 0 8 0
Annual Time Burden (Hours) 15,700 14,780 0 0 920 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The adjustment in burden from 14,780 to 15,700 hours is the result of an increase in the number of designation requests and premeeting packages submitted over the past three years.

$0
No
No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov

  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.
12/30/2014


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