Draft Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics

ICR 201312-0910-015

OMB: 0910-0765

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2013-12-09
Supplementary Document
2013-12-09
Supplementary Document
2013-12-09
Supplementary Document
2013-12-09
Supporting Statement A
2013-12-30
ICR Details
0910-0765 201312-0910-015
Historical Active
HHS/FDA 21067
Draft Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 03/25/2014
Retrieve Notice of Action (NOA) 12/31/2013
  Inventory as of this Action Requested Previously Approved
03/31/2017 36 Months From Approved
211 0 0
19,890 0 0
0 0 0

This ICR collects information from sponsors and applicants who wish to obtain a priority review designation or breakthrough therapy designation and those who wish to disseminate promotional materials for a product under accelerated approval. FDA determines whether an application qualifies for priority review for every application, however, an applicant may expressly request priority review. Respondents submit information for priority review and breakthrough therapy designation requests, including the proposed indication and a summary of the information that supports the designation request, as described in the guidance. Respondents submit promotional materials for accelerated approval under 21 CFR 314.550, including promotional labeling as well as advertisements, as described in the regulation. FDA uses the information submitted in priority review and breakthrough therapy designation requests to assess whether drug products meet the criteria for the designations. FDA uses the information from promotional materials for accelerated approval products to assess whether the material complies with FDA requirements

None
None

Not associated with rulemaking

  78 FR 38349 06/26/2013
78 FR 66939 11/07/2013
Yes

  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 211 0 0 211 0 0
Annual Time Burden (Hours) 19,890 0 0 19,890 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new information collection request.

$1,438,889
No
No
No
No
No
Uncollected
ILa Mizrachi 301 796-7726 ila.miz[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.
12/31/2013


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