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

ICR 201802-0910-005

OMB: 0910-0389

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
6040
Modified
186322
Removed
ICR Details
0910-0389 201802-0910-005
Historical Active 201412-0910-016
HHS/FDA CDER
Guidance for Industry: Fast Track Drug Development Programs - Designation, Development, and Application Review
Revision of a currently approved collection   No
Regular
Approved without change 04/27/2018
Retrieve Notice of Action (NOA) 02/13/2018
  Inventory as of this Action Requested Previously Approved
04/30/2021 36 Months From Approved 04/30/2018
1 0 203
1 0 15,700
0 0 0

To be discontinued upon OMB approval to consolidate into Control No. 0910-0765.

US Code: 21 USC 356 Name of Law: FFDCA; Fast track products
  
None

Not associated with rulemaking
Other Documents for OIRA Review

  82 FR 51846 11/08/2017
83 FR 5428 02/07/2018
No

1
IC Title Form No. Form Name
Fast track designation and premeeting packages
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 1 203 0 0 -202 0
Annual Time Burden (Hours) 1 15,700 0 0 -15,699 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
ICR to be discontinued upon OMB approval of revision to Control No. 0910-0765; thus burden reflects reduction to one response and one burden hour pending review. A separate revision request has been submitted under OMB Control No. 0910-0765.

$0
No
    No
    No
No
No
No
Uncollected
Domini Bean 301 796-5733 domini.bean@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.
02/13/2018


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