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

Forms and Documents

Document Name	Status
SSA Individual Patient Expanded Access Applications REVISED CLEAN.doc Supporting Statement A	2016-04-25

IC Document Collections

IC ID	Document Title	Status
220651	Expanded Access Submission for Treatment of an Individual Patient, Including Submission of Form FDA 3926 Other-Guidance	New

ICR Details

OMB Control No: 0910-0814	ICR Reference No: 201603-0910-009
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Guidance for Industry on Individual Patient Expanded Access Applications: Form FDA 3926
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 04/25/2016
	Date Received in OIRA: 03/24/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2019	36 Months From Approved
Responses	2,394	0	0
Time Burden (Hours)	1,796	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: 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).

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Authorizing Statute(s): US Code: 21 USC 360bbb Name of Law: FD&C Act
  

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:
	80 FR 7318	02/10/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 12908	03/11/2016
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Expanded Access Submission for Treatment of an Individual Patient, Including Submission of Form FDA 3926	3926	Individual Patient Expanded Access Investigational New Drug Application

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ICR Summary of Burden

	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

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: 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.

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Annual Cost to Federal Government: $134,159

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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? Uncollected

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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: 03/24/2016

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