Expedited Programs for Serious Conditions-Drugs and Biologics

ICR 202102-0910-008

OMB: 0910-0765

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2021-03-25
ICR Details
0910-0765 202102-0910-008
Received in OIRA 201809-0910-004
HHS/FDA CDER
Expedited Programs for Serious Conditions-Drugs and Biologics
Extension without change of a currently approved collection   No
Regular 03/26/2021
  Requested Previously Approved
36 Months From Approved 04/30/2021
948 559
71,090 35,765
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.

US Code: 21 USC 356 Name of Law: FFDCA; Expedited Approval of Drugs
  
None

Not associated with rulemaking

  85 FR 73487 11/18/2020
86 FR 10095 02/16/2021
Yes

  Total Request 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 948 559 0 0 389 0
Annual Time Burden (Hours) 71,090 35,765 0 0 35,325 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
Based on a review of the information collection since our last request for OMB approval, we have increased our burden estimate by 389 responses and 35,325 hours to reflect submissions we have received.

$0
No
    No
    No
No
No
No
No
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.
03/26/2021


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