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
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
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.