Expedited Programs for Serious Conditions-Drugs and Biologics

ICR 202408-0910-006

OMB: 0910-0765

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2024-08-23
ICR Details
0910-0765 202408-0910-006
Received in OIRA 202407-0910-004
HHS/FDA CDER
Expedited Programs for Serious Conditions-Drugs and Biologics
Revision of a currently approved collection   No
Regular 08/23/2024
  Requested Previously Approved
36 Months From Approved 09/30/2024
1,091 948
81,440 71,090
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

  89 FR 11011 01/08/2024
89 FR 27767 04/18/2024
No

  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 1,091 948 0 0 143 0
Annual Time Burden (Hours) 81,440 71,090 0 0 10,350 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 143 responses and 10,350 hours to reflect actual submissions we have received. Also, we have added the Regenerative Medicine Therapies for Serious Conditions program to this information collection as another expedited program. There is increased interest in the expedited programs and accelerated approval designations.

$1,626,740
No
    No
    No
No
No
No
No
Amber Sanford 301 796-8867 amber.sanford@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.
08/23/2024


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