Expanded Access to Investigational Drugs for Treatment Use

ICR 202203-0910-005

OMB: 0910-0814

Federal Form Document

ICR Details
0910-0814 202203-0910-005
Received in OIRA 202106-0910-011
HHS/FDA CDER
Expanded Access to Investigational Drugs for Treatment Use
Revision of a currently approved collection   No
Regular 04/29/2022
  Requested Previously Approved
36 Months From Approved 05/31/2022
13,910 2,394
255,326 1,796
0 0

This ICR collects information from licensed physicians who submit requests for expanded access to investigational drugs on behalf of individual patients. Physicians may use Form FDA 3926 instead of Form FDA 1571 for the submission of information as described in the regulations (e.g., the rationale for the intended use of the drug and the physician’s qualifications). We use the information to determine whether the access request can be granted. Form FDA 3926 may also be used for certain follow-up submissions to existing individual patient expanded access INDs as described in FDA regulations (e.g., to submit an annual report or summary of expanded access use (treatment completed)).

US Code: 21 USC 360bbb Name of Law: FD&C Act; Expanded Access to Unapproved Therapies and Diagnostics
  
None

Not associated with rulemaking

  86 FR 71069 12/14/2021
87 FR 25282 04/28/2022
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 13,910 2,394 0 0 11,516 0
Annual Time Burden (Hours) 255,326 1,796 0 0 253,530 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
We have made no program changes, however, on our own initiative, and for efficiency Agency operations, we are revising the information collection to consolidate all of the expanded access programs from 0910-0014 into 0910-0814. The change of the reported burden in OMB Control No. 0910-0014 will be adjusted as appropriate. The information collection reflects an increase in 253,530 burden hours and 11,516 responses annually.

$11,795,000
No
    Yes
    No
No
No
No
No
Amber Sanford 301 796-8867 [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.
04/29/2022


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