Guidance for Industry (GFI): Expedited Programs for Serious Conditions-Drugs and Biologics

ICR 201703-0910-010

OMB: 0910-0765

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2017-03-15
ICR Details
0910-0765 201703-0910-010
Historical Active 201312-0910-015
HHS/FDA CDER
Guidance for Industry (GFI): Expedited Programs for Serious Conditions-Drugs and Biologics
Extension without change of a currently approved collection   No
Regular
Approved without change 05/18/2017
Retrieve Notice of Action (NOA) 03/15/2017
  Inventory as of this Action Requested Previously Approved
05/31/2020 36 Months From Approved 05/31/2017
193 0 211
10,310 0 19,890
0 0 0

This ICR collects information from sponsors and applicants who wish to obtain a priority review designation or breakthrough therapy designation. Respondents to the collection are manufacturers or sponsors of drug and/or biologic products.

None
None

Not associated with rulemaking

  81 FR 85973 11/29/2016
82 FR 13816 03/15/2017
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 193 211 0 0 -18 0
Annual Time Burden (Hours) 10,310 19,890 0 0 -9,580 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$257,513
No
No
No
No
No
Uncollected
Domini Bean 301 796-5733 [email protected]

  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.
03/15/2017


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