3926 Individual Patient Expanded Access Investigational New D

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Individual Patient Expanded Access
Investigational New Drug Application (IND)

Form Approved: OMB No. xxxx-xxxx
Expiration Date: Xxxxxxx xx, 201x
See PRA Statement on last page.

(Title 21, Code of Federal Regulations (CFR) Part 312)
1. Patient’s Initials
3.a. Initial Submission
Select this box if this form is an
initial submission for an individual
patient expanded access IND,
and complete only fields 4
through 8, and fields 10 and 11.

2. Date of Submission (mm/dd/yyyy)
3.b. Follow-Up Submission
Select this box if this form accompanies
a follow-up submission to an existing
individual patient expanded access IND,
and complete the items to the right in this
section, and fields 8 through 11.

Investigational Drug Name

Physician’s IND Number

4. Clinical Information
Indication

Brief Clinical History (Patient’s age, gender, weight, allergies, diagnosis, prior therapy, response to prior therapy, reason for
request, including an explanation of why the patient lacks other therapeutic options)

5. Treatment Information
Investigational Drug Name
Name of the entity that will supply the drug (generally the manufacturer)
FDA Review Division (if known)
Treatment Plan (Including the dose, route and schedule of administration, planned duration, and monitoring procedures. Also include
modifications to the treatment plan in the event of toxicity.)

6. Letter of Authorization (LOA), if applicable (generally obtained from the manufacturer of the drug)
I have attached the LOA. (Attach the LOA; if electronic, use normal PDF functions for file attachments.)
Note: If there is no LOA, consult the Form Instructions.

FORM FDA 3926 (2/16)

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7. Physician’s Qualification Statement (Including medical school attended, year of graduation, medical specialty, state medical
license number, current employment, and job title. Alternatively, attach the first few pages of physician’s curriculum vitae (CV),
provided they contain this information. If attaching the CV electronically, use normal PDF functions for file attachments.)

8. Physician Name, Address, and Contact Information
Physician Name (Sponsor)

Email Address of Physician

Address 1 (Street address, No P.O. boxes)
Address 2 (Apartment, suite, unit, building, floor, etc.)
City

Telephone Number of Physician
State

Facsimile (FAX) Number of Physician

ZIP Code

Physician’s IND number, if known

9. Contents of Submission
This submission contains the following materials, which are attached to this form (select all that apply). If none of the following apply to the
follow-up communications, use Form FDA 1571 for your submission.
Initial Written IND Safety Report

Change in Treatment Plan

Follow-up to a Written IND Safety Report

General Correspondence

Annual Report

Response to FDA Request for Information

Summary of Expanded Access Use (treatment completed)

Response to Clinical Hold

10. Request for Authorization to Use Form FDA 3926
I request authorization to submit this Form FDA 3926 to comply with FDA’s requirements for an individual patient expanded access IND.

11. Certification Statement: I will not begin treatment until 30 days after FDA’s receipt of a completed application and all

required materials unless I receive earlier notification from FDA that treatment may begin. I also agree not to begin or
continue clinical investigations covered by the IND if those studies are placed on clinical hold. I also certify that I will obtain
informed consent, consistent with Federal requirements, and that an Institutional Review Board (IRB) that complies with the
Federal IRB requirements will be responsible for initial and continuing review and approval of this treatment use. I understand
that in the case of an emergency request, treatment may begin without prior IRB approval, provided the IRB is notified of the
emergency treatment within 5 working days of treatment. I agree to conduct the investigation in accordance with all other
applicable regulatory requirements.

WARNING: A willfully false statement is a criminal offense (U.S.C. Title 18, Sec. 1001).
Signature of Physician

Date

For FDA Use Only
Date of FDA Receipt
IND Number

FORM FDA 3926 (2/16)

Is this an emergency individual patient IND?
Yes

No

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Is this indication for a rare disease (prevalence
< 200,000 in the U.S.)?
Yes

No

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Food and Drug Administration
Office of Chief Information Officer
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FORM FDA 3926 (2/16)

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