Guidance for Industry on Individual Patient Expanded Access Applications: Form FDA 3926

ICR 201603-0910-009

OMB: 0910-0814

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2016-04-25
ICR Details
0910-0814 201603-0910-009
Historical Active
HHS/FDA CDER
Guidance for Industry on Individual Patient Expanded Access Applications: Form FDA 3926
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 04/25/2016
Retrieve Notice of Action (NOA) 03/24/2016
  Inventory as of this Action Requested Previously Approved
04/30/2019 36 Months From Approved
2,394 0 0
1,796 0 0
0 0 0

This ICR collects information from licensed physicians who wish to submit a request for expanded access to an investigational drug outside of a clinical investigation, or to an approved drug where availability is limited by a risk evaluation and mitigation strategy (REMS), for an individual patient who has a serious or immediately life-threatening disease or condition and there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition. FDA developed Form FDA 3926 (Individual Patient Expanded Access Investigational New Drug Application (IND)) for physicians to use as a streamlined alternative to Form FDA 1571 (Investigational New Drug Application (IND)). Physicians submit information as described in FDA regulations -- for example, the cover sheet, the rationale for the intended use of the drug, and the physician’s qualifications. FDA uses the information to determine if the expanded access request is allowed to proceed or if the application will be put on clinical hold. Form FDA 3926 may also be used for certain follow-up submissions to existing individual patient expanded access INDs as described in FDA regulations, for example, to submit an annual report or summary of expanded access use (treatment completed).

US Code: 21 USC 360bbb Name of Law: FD&C Act
  
None

Not associated with rulemaking

  80 FR 7318 02/10/2015
81 FR 12908 03/11/2016
Yes

  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 0 0 2,394 0 0
Annual Time Burden (Hours) 1,796 0 0 1,796 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
There have been no program changes or adjustments because this is a new request for OMB approval. However, as noted above, FDA currently has OMB approval under control number 0910-0014 for individual patient expanded access information collection under §§312.305(b), 312.310(b), and 312.310(d). FDA currently has OMB approval of 17,592 hours for these submissions. The use of Form FDA 3926 will reduce the current burden by 15,797 hours. We intend to make the appropriate adjustments in 0910-0014 during the next extension request.

$134,159
No
No
No
No
No
Uncollected
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.
03/24/2016


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