Notice2026-20765
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Expanded Access to Investigational Drugs for Treatment Use
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 9, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 91 Issue 195 (Friday, October 9, 2026)</title>
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[Federal Register Volume 91, Number 195 (Friday, October 9, 2026)]
[Notices]
[Pages 64659-64660]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20765]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-7426]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Expanded Access to
Investigational Drugs for Treatment Use
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by November 9, 2026.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0814. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 240-402-5733,
<a href="/cdn-cgi/l/email-protection#2a7a786b795e4b4c4c6a4c4e4b04424259044d455c"><span class="__cf_email__" data-cfemail="fbaba9baa88f9a9d9dbb9d9f9ad5939388d59c948d">[email protected]</span></a>.
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:
<bullet> 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).''
<bullet> 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 (<a href="http://www.fda.gov/news-events/public-health-focus/expanded-access">www.fda.gov/news-events/public-health-focus/expanded-access</a>), 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
<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/expanded-access-investigational-drugs-treatment-use-questions-and-answers">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/expanded-access-investigational-drugs-treatment-use-questions-and-answers</a>, 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:
[[Page 64660]]
Table 1--Estimated Annual Recordkeeping Burden--Center for Drug Evaluation and Research \1\ \2\ \3\
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Number of
Number of responses Total Average burden per Total
21 CFR section; activity respondents per annual response hours
respondent responses
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Sec. Sec. 312.310(b) and 752 1.3484 1,014 0.75 (45 minutes)..... 761
312.305(b); submissions related to
expanded access and treatment of an
individual patient: Form FDA 3926.
Sec. Sec. 312.310(b) and 10 10.8 108 3..................... 324
312.305(b); submissions related to
expanded access and treatment of an
individual patient: Form FDA 1571.
Sec. 312.310(d); submissions 394 1.1371 448 0.75 (45 minutes)..... 336
related to expanded access and
treatment of an individual patient
for emergency use: Form FDA 3926.
Sec. 312.310(d); submissions 7 3.2857 23 3..................... 69
related to expanded access and
treatment of an individual patient
for emergency use: Form FDA 1571.
Sec. Sec. 312.315(c) and 37 1.0541 39 120................... 4,680
312.305(b); submissions related to
expanded access and treatment of an
intermediate-size patient
population (Form FDA 1571).
Sec. 312.320(b) and 312.305(b); 18 1.0555 19 300................... 5,700
submissions related to a treatment
IND or treatment protocol (Form FDA
1571).
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Total........................... ............ ............ 1,651 ...................... 11,870
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Numbers may be rounded.
Table 2--Estimated Annual Recordkeeping Burden--Center for Biologics Evaluation and Research \1\ \2\ \3\
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Number of
Number of responses Total Average Total
21 CFR section; activity respondents per annual burden per hours
respondent responses response
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Sec. Sec. 312.310(b) and 312.305(b); number 256 1.4804 379 8 3,032
of submissions related to expanded access and
treatment of an individual patient: Form FDA
3926...........................................
Sec. 312.310(d); number of submissions related 80 1.2 96 16 1,536
to emergency use of an investigational new
drug: Form FDA 3926............................
Sec. Sec. 312.315(c) and 312.305(b); number 14 1 14 120 1,680
of submissions related to expanded access and
treatment of an intermediate-size patient
population: Form FDA 1571......................
Sec. 312.320(b) and 312.305(b); number of 3 1 3 300 900
submissions related to a treatment IND or
treatment protocol: Form FDA 1571..............
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Total....................................... ............ ............ 492 .......... 7,148
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\3\ Numbers may be rounded.
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.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-20765 Filed 10-8-26; 8:45 am]
BILLING CODE 4164-01-P
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