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

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Expanded Access to Investigational Drugs for Treatment Use

DATES:

Submit written comments (including recommendations) on the collection of information by November 9, 2026.

SUPPLEMENTARY INFORMATION:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Expanded Access to Investigational Drugs for Treatment Use

OMB Control Number 0910-0814-Revision

This information collection helps support implementation of Food and Drug Administration (FDA, agency, us or we) regulations, as well as agency forms and associated guidance. Provisions in section 561 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb) set forth general requirements relating to expanded access to unapproved therapies and diagnostics. Sometimes called " compassionate use," expanded access (EA) is a potential pathway for a patient with an immediately life-threatening condition, or serious 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. To facilitate expanded access to investigational drugs by patients, regulations in 21 CFR part 312, subpart I; Expanded Access to Investigational Drugs for Treatment Use (21 CFR 312.300-21 CFR 312.320), establish submission requirements that include demonstrating certain criteria have been met, and that content and format requirements have been satisfied. Information collection associated with all other provisions in 21 CFR 312 are included in OMB control no. 0910-0014 unless specifically noted.

The information collection utilizes Form FDA 3926 entitled, "Individual Patient Expanded Access-Investigational New Drug Application (IND)." Form FDA 3926 requires the completion of data fields that enable us to uniformly collect the minimum information necessary from licensed physicians or industry who want to request expanded access as prescribed in the applicable regulations. We are revising Form FDA 3926 as follows:

• 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)."
• In Field 9, replace the heading "Contents of Submission" with "Contents of Submission (follow-up/additional submissions only)."

Upon OMB approval of these modifications, we will revise accompanying instructions. Respondents may continue to use either Form FDA 3926 or Form FDA 1571, Investigational New Drug Application (IND) (approved under OMB control number 0910-0014), for all types of IND submissions to satisfy requirements in 21 CFR 312.23(a). 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.

We continue to maintain an expanded access website ( www.fda.gov/news-events/public-health-focus/expanded-access ), including associated guidance documents. Regulations in 21 CFR 312.145 (approved in control. 0910-0014) provide for the issuance of guidance documents by FDA to assist respondents in complying with applicable regulations in 21 CFR 312. The guidance document "Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers," (April 2026), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/expanded-access-investigational-drugs-treatment-use-questions-and-answers, supplements reporting instructions applicable to Form FDA 3926.

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

In the Federal Register of July 28, 2026 (91 FR 47248), we published a 60-day notice requesting public comment on the proposed collection of information. One comment letter was received, containing multiple comments.

One comment was supportive of the proposed revisions to Form FDA 3926, stating that the changes to the form were appropriate and should make it easier to access investigational therapies efficiently. Other comments stated that the information collected through expanded access should not merely satisfy administrative requirements and suggested that the information collection should be used to facilitate the collection of meaningful and standardized information, including safety data, patient-reported outcomes, biomarker information, and other real-world clinical observations. We appreciate the comment and will take the concerns raised into consideration in future evaluations. No changes were made to the information collection or burden estimates as a result of the comment.

We estimate the burden of the collections of information as follows:

Burden estimates we attribute to the recordkeeping requirements established by the applicable regulations have been updated to include the reporting of data elements using Form FDA 1571. We have characterized the collection activity as recordkeeping, consistent with 5 CFR 1320.3(m) which defines a recordkeeping requirement to include the task of reporting the records to the Federal government. Upon our most recent review, the information collections reflect a cumulative decrease of 11,767 responses and 236,308 burden hours annually.