Expanded Access to Investigational Drugs for Treatment Use

Forms and Documents

Document Name	Status
Form FDA 3926 (CBER) Submissions related to emergency use of an investigational new drug Form	New
Form FDA 3926 (CBER) Submissions related to expanded access and treatment of an individual patient Form	New
Form FDA 3926 (CDER) Submissions related to emergency use of an investigational new drug Form	New
Form Individual Patient (CDER) Submissions related to expanded access and treatment of an individual patient Form	New
0814_Supporting Statement_2022.docx Supporting Statement A	2022-04-29

IC Document Collections

IC ID	Document Title	Status
253124	(CBER) Submissions related to a treatment IND or treatment protocol	New
253123	(CBER) Submissions related to expanded access and treatment of an intermediate-size patient population	New
253122	(CBER) Submissions related to emergency use of an investigational new drug Form	New
253121	(CBER) Submissions related to expanded access and treatment of an individual patient Form	New
253120	(CDER) Submissions related to a treatment IND or treatment protocol	New
253119	(CDER) Submissions related to expanded access and treatment of an intermediate-size patient population	New
253118	(CDER) Submissions related to emergency use of an investigational new drug Form	New
253117	(CDER) Submissions related to expanded access and treatment of an individual patient Form	New
220651	Expanded Individual Patient Access Application Submissions Other-Agency Guidance	Removed

ICR Details

OMB Control No: 0910-0814	ICR Reference No: 202203-0910-005
Status: Received in OIRA	Previous ICR Reference No: 202106-0910-011
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Expanded Access to Investigational Drugs for Treatment Use
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 04/29/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved	05/31/2022
Responses	13,910	2,394
Time Burden (Hours)	255,326	1,796
Cost Burden (Dollars)	0	0

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Abstract: 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)).

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Authorizing Statute(s): US Code: 21 USC 360bbb Name of Law: FD&C Act; Expanded Access to Unapproved Therapies and Diagnostics
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 71069	12/14/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 25282	04/28/2022
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 8

IC Title	Form No.	Form Name
(CBER) Submissions related to a treatment IND or treatment protocol
(CBER) Submissions related to emergency use of an investigational new drug	FDA 3926	Individual Patient Expanded Access Investigational
(CBER) Submissions related to expanded access and treatment of an individual patient	FDA 3926	Individual Patient Expanded Access Investigational
(CBER) Submissions related to expanded access and treatment of an intermediate-size patient population
(CDER) Submissions related to a treatment IND or treatment protocol
(CDER) Submissions related to emergency use of an investigational new drug	FDA 3926	Individual Patient Expanded Access Investigational
(CDER) Submissions related to expanded access and treatment of an individual patient	Individual Patient Expanded Access Investigational	Form FDA 3926
(CDER) Submissions related to expanded access and treatment of an intermediate-size patient population
Expanded Individual Patient Access Application Submissions	Form FDA 3926	Individual Patient Expanded Access Investigational New Drug Application

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ICR Summary of Burden

	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

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: 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.

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Annual Cost to Federal Government: $11,795,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 04/29/2022

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