Agency Information Collection Activities; Proposals, Submissions, and Approvals: Expanded Access to Investigational Drugs for Treatment Use

Agency Information Collection Activities; Proposed Collection; Comment Request; Expanded Access to Investigational Drugs for Treatment Use

DATES:

Either electronic or written comments on the collection of information must be submitted by September 28, 2026.

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.

• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see "Written/Paper Submissions" and "Instructions").

Written/Paper Submissions

Submit written/paper submissions as follows:

• Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in "Instructions."

Instructions: All submissions received must include the Docket No. FDA-2026-N-7426 for "Agency Information Collection Activities; Proposed Collection; Comment Request; Expanded Access to Investigational Drugs for Treatment Use." Received comments, those filed in a timely manner (see ADDRESSES ), will be placed in the docket and, except for those submitted as "Confidential Submissions," publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

• Confidential Submissions-To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states "THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION." The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as "confidential." Any information marked as "confidential" will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the "Search" box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

SUPPLEMENTARY INFORMATION:

Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. "Collection of information" is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Expanded Access to Investigational Drugs for Treatment Use

OMB Control Number 0910-0814-Revision

This information collection supports Agency regulations in 21 CFR part 312, subpart I, Expanded Access to Investigational Drugs for Treatment Use; associated guidance; and Form FDA 3926, Individual Patient Expanded Access Investigational New Drug Application (IND). The regulations govern the use of investigational new drugs, biologics, and approved drugs, when the primary purpose is to diagnose, monitor, or treat a patient's disease or condition. The goal of the expanded access program is to facilitate the availability of such products to patients with serious diseases or conditions when there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the patient's disease or condition.

Sometimes called "compassionate use," expanded access (EA) is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. Agency regulations in 21 CFR part 312 provide for individual patient EA and associated procedures for those submitting EA requests to FDA. We provide resource information on our website at https://www.fda.gov/news-events/public-health-focus/expanded-access regarding our EA program, including information for patients, physicians, and industry. We also provide information pertaining to forms and processes for submitting EA requests to FDA.

This information collection accounts for burden associated with the submission of expanded access requests for individual patients and other expanded access submissions, including INDs that involve large groups of patients enrolled for treatment use of the investigational drug (§§ 312.300 through 312.320 (21 CFR 312.300 through 312.320)).

We developed electronic Form FDA 3926 to assist respondents with the information collection. Upon accessing the online form, users may need to follow certain technical instructions to save the document in a portable document format (PDF). Form FDA 3926 requires the completion of data fields that enable us to uniformly collect the minimum information necessary from licensed physicians who want to request EA as prescribed in the applicable regulations. To supplement the form instructions, we issued guidance, most recently updated in April 2026, titled "Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers," available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/expanded-access-investigational-drugs-treatment-use-questions-and-answers. As discussed in the guidance, § 312.310(b) contains additional submission requirements for individual patient expanded access requests. These respondents may continue to use either Form FDA 3926 or Form FDA 1571, Investigational New Drug Application (IND), for all types of IND submissions to satisfy requirements in 21 CFR 312.23(a) (approved under OMB control number 0910-0014). FDA considers a completed Form FDA 3926 signed by the physician and checked in the box in Field 10.a (Request for Authorization to use Form FDA 3926) to be a waiver request in accordance with 21 CFR 312.10.

For additional clarity, we have proposed several revisions to Table 1, including adding rows and more complete descriptive text to more accurately represent the submissions we receive and, in some cases, reducing our estimate of the hours per response to more accurately reflect the time we expect it will take to prepare and submit individual patient expanded access requests.

We also are proposing the following revisions to data elements in Form FDA 3926. In Field 6, "Treatment Information," delete the data element "Investigational Drug Name" and replace it with "Planned Date of Treatment Initiation" and revise the data element "FDA Review Division (if known)" to read "FDA Office/Review Division (if known)". We will make corresponding revisions to the form instructions. In Field 9, replace the heading "Contents of Submission" with "Contents of Submission (follow-up/additional submissions only)" to correspond with the text in the instructions.

Data elements in §§ 312.315 and 312.320 continue to be reported in Form FDA 1571 (approved under OMB control number 0910-0014).

Description of Respondents: Respondents to the collection of information are licensed physicians who request patient access to investigational drugs.

FDA estimates the burden of this collection of information as follows:

We have reevaluated the burden of EA submissions reported in Table 1. We reevaluated our estimate of the average burden per response in row 3 for submissions for expanded access and treatment of an individual patient on Form FDA 3926. We estimate the time needed to complete Form FDA 3926 (0.75 hour or 45 minutes) should be the same irrespective of whether it is submitted for emergency or non-emergency single patient IND. In doing so, we corrected an overreporting. We also revised Table 1 to add rows 2 and 4. These rows reflect our estimates for EA submissions for expanded access and treatment of an individual patient on Form FDA 1571. We estimate that preparing Form FDA 1571 for an individual patient will take a provider about four times as long as preparing Form FDA 3926, or 3 hours. As with the use of Form FDA 3926, we estimate the time needed to complete Form FDA 1571 will be the same whether the submission is for emergency or non-emergency single patient IND.

This information collection reflects program changes and adjustments. We propose to revise data elements in Form FDA 3926 and to reevaluate the burden of EA submissions reported in Table 1, as described. We also report a decrease in submissions since the last OMB review and approval of the information collection. As a result of these cumulative changes and adjustments, the information collection reflects an overall decrease of 11,767 responses and 236,308 burden hours.