Individual Patient Expanded Access Applications

ICR 202009-0910-005

OMB: 0910-0814

Federal Form Document

Forms and Documents
Document
Name
Status
Justification for No Material/Nonsubstantive Change
2020-09-09
Supporting Statement A
2019-04-19
IC Document Collections
ICR Details
0910-0814 202009-0910-005
Active 201903-0910-003
HHS/FDA CDER
Individual Patient Expanded Access Applications
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 09/10/2020
Retrieve Notice of Action (NOA) 09/09/2020
  Inventory as of this Action Requested Previously Approved
05/31/2022 05/31/2022 05/31/2022
2,394 0 2,394
1,796 0 1,796
0 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

  83 FR 55723 11/07/2018
84 FR 16022 04/17/2019
No

1
IC Title Form No. Form Name
Expanded Individual Patient Access Application Submissions Form FDA 3926 Individual Patient Expanded Access Investigational New Drug Application

  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 2,394 2,394 0 0 0 0
Annual Time Burden (Hours) 1,796 1,796 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$134,159
No
    Yes
    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.
09/09/2020


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