Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Application Requirements

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

March 13, 2026

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with investigational new drugs and investigational new drug applications.

Full Text

<html>
<head>
<title>Federal Register, Volume 91 Issue 49 (Friday, March 13, 2026)</title>
</head>
<body><pre>
[Federal Register Volume 91, Number 49 (Friday, March 13, 2026)]
[Notices]
[Pages 12422-12427]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-04938]

[[Page 12422]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2026-N-1736]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Investigational New Drug Application Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on information collection associated with
investigational new drugs and investigational new drug applications.

DATES: Either electronic or written comments on the collection of
information must be submitted by May 12, 2026.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 12, 2026. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.

Electronic Submissions

Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-1736 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Investigational New Drug
Application Requirements.''
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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.

FOR FURTHER INFORMATION CONTACT: Anne Taylor, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 240-402-5683,
<a href="/cdn-cgi/l/email-protection#89d9dbc8dafde8efefc9efede8a7e1e1faa7eee6ff"><span class="__cf_email__" data-cfemail="feaeacbfad8a9f9898be989a9fd096968dd0999188">[email&#160;protected]</span></a>.

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

[[Page 12423]]

collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.

Investigational New Drug Application Requirements--21 CFR Part 312

OMB Control Number 0910-0014--Extension

This information collection supports implementation of provisions
of section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 355) and of the licensing provisions of the Public Health
Service Act (42 U.S.C. 201 et seq.) that govern investigational new
drugs and investigational new drug applications (INDs). Implementing
regulations are found in part 312 (21 CFR part 312), and provide for
the issuance of guidance documents (see Sec. 312.145 (21 CFR 312.145))
to assist persons in complying with the applicable requirements. The
information collection applies to all clinical investigations subject
to section 505 of the FD&C Act and include the following types of INDs:
<bullet> An Investigator IND is submitted by a physician who both
initiates and investigates, and under whose immediate direction the
investigational drug is administered or dispensed. A physician might
submit a research IND to propose studying an unapproved drug or an
approved product for a new indication or in a new patient population.
<bullet> Emergency Use IND allows FDA to authorize use of an
experimental drug in an emergency situation that does not allow time
for submission of an IND in accordance with Sec. 312.23 or Sec.
312.20 (21 CFR 312.23 or 312.20). It is also used for patients who do
not meet the criteria of an existing study protocol or if an approved
study protocol does not exist.
<bullet> Treatment IND is submitted for experimental drugs showing
promise in clinical testing for serious or immediately life-threatening
conditions while the final clinical work is conducted and FDA's review
takes place.
There are two IND categories: commercial and research (non-
commercial).
General IND requirements include submitting an initial application
as well as amendments to that application; submitting reports on
significant revisions of clinical investigation plans; submitting
information to the clinical trials data bank (<a href="https://clinicaltrials.gov">https://clinicaltrials.gov</a>) established by the National Institutes of Health/
National Library of Medicine, including expanded information on certain
clinical trials and information on the results of these clinical
trials; and reporting information on a drug's safety or effectiveness.
In addition, sponsors are required to provide to FDA an annual summary
of the previous year's clinical experience. The regulations also
include recordkeeping requirements regarding the disposition of drugs,
records regarding individual case histories, and certain other
documentation verifying clinical investigators' fulfillment of
responsibilities.
Form FDA 1571 entitled ``Investigational New Drug Application
(IND)'' and Form FDA 1572 entitled ``Statement of Investigator,'' were
developed to assist respondents with the information collection and
provide for uniform reporting of required data elements. The
information is required to be submitted electronically. Individuals who
are interested in receiving printed forms may send an email request to
the FDA Forms Manager at <a href="/cdn-cgi/l/email-protection#264049544b554b4748474143546669650860626708616970"><span class="__cf_email__" data-cfemail="7d1b120f100e101c131c1a180f3d323e533b393c533a322b">[email&#160;protected]</span></a>. Fees may apply.
Sponsors (including sponsor-investigators) interested in filing or
updating a research IND may use a new web-based interface developed for
use by mobile device or desktop to help in completing Form FDA 1571.
The web-based interface also allows respondents to electronically
submit completed Form FDA 1571 and associated files. Form FDA 1571 was
recently updated to include the new tracking information for real world
evidence and real-world data (RWE/RWD). The new RWE/RWD fields will
capture submissions with RWE/RWD based on the requirements set forth in
the PDUFA VII commitment letter and the resulting Advancing Real World
Evidence Program, so that FDA can track and report on its performance
related to these commitments. In addition, collection of this data will
support the consistent integration of real-world evidence data into the
regulatory review and approval process for new drugs and biologics. For
more information regarding Forms FDA 1571 and 1572 visit <a href="https://www.fda.gov/news-events/expanded-access/how-complete-form-fda-1571-and-form-fda-1572">https://www.fda.gov/news-events/expanded-access/how-complete-form-fda-1571-and-form-fda-1572</a>.
Human drug, biological product, and device product submissions must
be accompanied by Form FDA 3674, as discussed in the guidance document
entitled ``Form FDA 3674--Certifications To Accompany Drug, Biological
Product, and Device Applications/Submissions'' (updated November 2017),
available from our website at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/form-fda-3674-certifications-accompany-drug-biological-product-and-device-applicationssubmissions">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/form-fda-3674-certifications-accompany-drug-biological-product-and-device-applicationssubmissions</a>.
The guidance document provides procedural instruction on completing and
submitting required information to FDA. As communicated in the
instructions, the certification must accompany the application or
submission and be included at the time of submission to FDA.
Regulations in part 312, subpart B, specify content and format
requirements for applications, amendments, annual reporting, and
withdrawals, including content and format requirements for protocol and
information amendments. The regulations also explain phases of an
investigation and set forth principles of IND submissions. To date we
have developed and issued the following guidance documents to assist
respondents:
<bullet> ``Establishment and Operation of Clinical Trial Data
Monitoring Committees'' guidance (March 2006); and
<bullet> ``Special Protocol Assessment'' guidance (April 2018).
All Agency guidance documents are issued in accordance with our
Good Guidance Practice regulations in 21 CFR 10.115, which provide for
public comment at any time. We maintain a searchable guidance database
on our website at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a> that utilizes topic specific search terms.
Regulations in part 312, subpart C, describe administrative actions
pertaining to respondents' requests for and responses to clinical
holds, terminations, and inactive IND status determinations, as well as
various types of meetings (for example, End-of-Phase 2 and Pre-new drug
application (NDA) meetings).
Regulations in part 312, subpart D, set forth sponsor and
investigator responsibilities, including general responsibilities;
transfer of obligations to a contract research organization;
recordkeeping and record retention controls; reporting
responsibilities; and responsibility for disposition of unused supply
of investigational drug. The regulations also provide for investigator
controls including review of ongoing investigations; compliance with
requirements regarding the protection of human subjects and
institutional review board assurance; and disqualification of clinical
investigators.
Regulations in part 312, subpart E, sets forth requirements
applicable to drugs intended to treat life-threatening and severely
debilitating illnesses. The

[[Page 12424]]

regulations establish procedures to reflect that physicians and
patients accept greater risk or side effects from products that treat
life-threatening and severely debilitating illnesses than they would
accept from products that treat less serious illnesses. The procedures
also reflect the recognition that the benefits of the drug need to be
evaluated in light of the severity of the disease being treated.
Regulations in part 312, subpart F, include provisions pertaining
to import and export requirements; foreign clinical studies not
conducted under an IND; the disclosure of data and information in an
IND; and the issuance of guidance documents. To date we have developed
and issued the following guidance documents to assist respondents:
<bullet> ``Oversight of Clinical Investigations'' guidance (August
2013);
<bullet> ``Pharmacogenomic Data Submissions'' guidance (March
2005);
<bullet> ``Adaptive Designs for Clinical Trials of Drugs and
Biologics'' guidance (December 2019); and
<bullet> ``E6(R2) Good Clinical Practice: Integrated Addendum to
ICH E6(R1)'' guidance (March 2018).
All Agency guidance documents are issued in accordance with our
Good Guidance Practice regulations in 21 CFR 10.115, which provide for
public comment at any time. We maintain a searchable guidance database
on our website at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a> that utilizes topic specific search terms.
Regulations in part 312, subpart G, provide for drugs for
investigational use in laboratory research animals or in vitro tests.
Finally, 21 CFR 300.200 requires the submission of an annual report
by sponsors and manufacturers who provide an ``eligible investigational
drug'' under the Right to Try Act. The regulation also establishes
content and format elements and requires that information be submitted
to FDA no later than March 31 of each year, including data for the
preceding calendar year. Respondents use Form FDA 5023 entitled ``Right
to Try Reporting Requirement: Annual Summary,'' currently available for
download from our website at <a href="https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try">https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try</a>-annual-reporting-
summary. As required by the applicable statute, section 561B of the
FD&C Act (21 U.S.C. 360bbb-0a), the information is submitted to an FDA-
designated point of contact, and in accordance with instructions to be
posted at: <a href="https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try">https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try</a>.
We estimate the burden of this collection of information as
follows:

Table 1--Estimated Annual Reporting Burden for Biologics \1\
----------------------------------------------------------------------------------------------------------------
Number of Total Average
21 CFR section; activity Number of responses per annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Subpart A--General Provisions: Sec. Sec. 312.1 through 312.10
----------------------------------------------------------------------------------------------------------------
Sec. 312.2(e); requests for FDA advice on 454 1.528 694 24 16,656
the applicability of part 312 to a planned
clinical investigation....................
Sec. 312.8; requests to charge for an 14 1.64 23 48 1,104
investigational drug......................
Sec. 312.10; waiver requests............. 5 1 5 24 120
--------------------------------------------------------------------
Subtotal Subpart A Center for Biologics ............ .............. 722 ........... 17,880
Evaluation and Research (CBER)........
----------------------------------------------------------------------------------------------------------------
Subpart B--Investigational New Drug Application (IND): Sec. Sec. 312.20 through 312.38 (Including Forms FDA
1571, 1572, and 3674)
----------------------------------------------------------------------------------------------------------------
Sec. 312.23(a) through (f); IND content 2,075 3.382 7,018 300 2,105,400
and format................................
Sec. 312.30(a) through (e); protocol 1,781 4.6692 8,316 284 2,361,744
amendments................................
Sec. 312.31(b); information amendments... 169 2.48 419 100 41,900
Sec. 312.32(c) and (d); IND safety 224 10.59 2,372 32 75,904
reports...................................
Sec. 312.33(a) through (f); IND annual 971 2.2739 2,208 360 794,880
reports...................................
Sec. 312.38(b) and (c); notifications of 712 3.057 2,177 28 60,956
withdrawal of an IND......................
--------------------------------------------------------------------
Subtotal Subpart B CBER................ ............ .............. 22,510 ........... 5,440,784
----------------------------------------------------------------------------------------------------------------
Subpart C--Administrative Actions: Sec. Sec. 312.40 through 312.48
----------------------------------------------------------------------------------------------------------------
Sec. 312.42; clinical holds and requests 154 1.65 254 284 72,136
for modification..........................
Sec. 312.44(c) and (d); sponsor responses 86 1.22 105 16 1,680
to FDA when IND is terminated.............
Sec. 312.45(a) and (b); sponsor requests 48 1.48 71 12 852
for or responses to an inactive status
determination of an IND by FDA............
Sec. 312.47; meetings, including ``End-of- 157 1.80 283 160 45,280
Phase 2'' meetings and ``Pre-NDA''
meetings..................................
--------------------------------------------------------------------
Subtotal Subpart C CBER................ ............ .............. 713 ........... 119,948
----------------------------------------------------------------------------------------------------------------
Subpart D--Responsibilities of Sponsors and Investigators: Sec. Sec. 312.50 through 312.70
----------------------------------------------------------------------------------------------------------------
Sec. 312.53(c); investigator reports 1,068 5.23 5,586 80 446,880
submitted to the sponsor, including Form
FDA 1572, curriculum vitae, clinical
protocol, and financial disclosure........
Sec. 312.54(a); sponsor submissions to 4 4.25 17 48 816
FDA concerning investigations involving an
exception from informed consent under Sec.
50.24...................................
Sec. 312.54(b); sponsor notifications to 1 1 1 48 48
FDA and others concerning an institutional
review board determination that it cannot
approve research because it does not meet
the criteria in the exception from
informed consent in Sec. 50.24(a).......
Sec. 312.55(a); number of investigator 473 2.224 1,052 48 50,496
brochures submitted by the sponsor to each
investigator..............................
Sec. 312.55(b); number of sponsor reports 243 4.95 1,203 48 57,744
to investigators on new observations,
especially adverse reactions and safe use.
Sec. 312.56(b), (c), and (d); review of 915 2.948 2,698 80 215,840
ongoing investigations and associated
notifications; sponsor notifications......
Sec. 312.58; inspection of records and 7 1 7 8 56
reports by FDA............................
Sec. 312.64; number of investigator 2,728 3.816 10,411 24 249,864
reports to the sponsor, including progress
reports, safety reports, final reports,
and financial disclosure reports..........

[[Page 12425]]

Sec. 312.70; disqualification of a 5 1 5 40 200
clinical investigator by FDA..............
--------------------------------------------------------------------
Subtotal Subpart D CBER................ ............ .............. 20,980 ........... 1,021,944
----------------------------------------------------------------------------------------------------------------
Subpart F--Miscellaneous: Sec. Sec. 312.110 through 312.145
----------------------------------------------------------------------------------------------------------------
Sec. 312.110(b)(4) and (b)(5); number of 18 1 18 75 1,350
written certifications and written
statements submitted to FDA relating to
the export of an investigational drug.....
Sec. 312.120(b); number of submissions to 280 9.82 2,750 32 88,000
FDA of ``supporting information'' related
to the use of foreign clinical studies not
conducted under an IND....................
Sec. 312.120(c); number of waiver 7 2.29 16 24 384
requests submitted to FDA related to the
use of foreign clinical studies not
conducted under an IND....................
Sec. 312.130; number of requests for 350 1.342 470 8 3,760
disclosable information in an IND and for
investigations involving an exception from
informed consent under Sec. 50.24.......
--------------------------------------------------------------------
Subtotal Subpart F CBER................ ............ .............. 3,254 ........... 93,494
--------------------------------------------------------------------
Total.............................. ............ .............. 48,179 ........... 6,694,050
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

Table 2--Estimated Annual Recordkeeping Burden for Biologics \1\
----------------------------------------------------------------------------------------------------------------
Number of Total
21 CFR section; activity Number of records per annual Average burden per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Subpart D--Responsibilities of Sponsors and Investigators: Sec. Sec. 312.50 through 312.70
----------------------------------------------------------------------------------------------------------------
Sec. 312.52(a); sponsor 94 2.26 212 2...................... 424
records for the transfer of
obligations to a contract
research organization.
Sec. 312.57; sponsor 335 2.70 904 100.................... 90,400
recordkeeping showing the
receipt, shipment, or other
disposition of the
investigational drug, and any
financial interest.
Sec. 312.62(a); investigator 453 1 453 40..................... 18,120
recordkeeping of the
disposition of drugs.
Sec. 312.62(b); investigator 453 1 453 40..................... 18,120
recordkeeping of case
histories of individuals.
---------------------------------------------------------------------------------
Subtotal Subpart D CBER... .............. .............. 2,022 ....................... 127,064
----------------------------------------------------------------------------------------------------------------
Subpart G--Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests
----------------------------------------------------------------------------------------------------------------
Sec. 312.160(a)(3); records 111 1.40 155 0.5 (30 minutes)....... 78
pertaining to the shipment of
drugs for investigational use
in laboratory research
animals or in vitro tests.
Sec. 312.160(c) shipper 111 1.40 155 0.5 (30 minutes)....... 78
records of alternative
disposition of unused drugs.
---------------------------------------------------------------------------------
Subtotal Subpart G CBER... .............. .............. 310 ....................... 156
---------------------------------------------------------------------------------
Total................. .............. .............. 2,332 ....................... 127,220
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

Table 3--Estimated Annual Reporting Burden for Human Drugs \1\
----------------------------------------------------------------------------------------------------------------
Number of Total Average
21 CFR section; activity Number of responses per annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Subpart A--General Provisions
----------------------------------------------------------------------------------------------------------------
Sec. 312.2(e); requests for FDA advice on 419 1 419 24 10,056
the applicability of part 312 to a planned
clinical investigation.....................
Sec. 312.8; requests to charge for an 25 1.28 32 48 1,536
investigational drug.......................
Sec. 312.10; requests to waive a 68 1.5 102 24 2,448
requirement in part 312....................
-------------------------------------------------------------------
Subtotal Subpart A Center for Drug ........... .............. 553 ........... 14,040
Evaluation and Research (CDER).........
----------------------------------------------------------------------------------------------------------------
Subpart B--Investigational New Drug Application (IND)
----------------------------------------------------------------------------------------------------------------
Sec. 312.23(a) through (f); IND content 4,886 1.4662 7,164 300 2,149,200
and format (including Forms FDA 1571 and
3674)......................................
Sec. 312.30(a) through (e); protocol 11,847 3.2367 38,346 284.25 10,899,850
amendments.................................
Sec. 312.31(b); information amendments.... 8,094 3.30899 26,783 100 2,678,300
Sec. 312.32(c) and (d); IND safety reports 892 15.848 14,137 32 452,384
Sec. 312.33(a) through (f); IND annual 3,777 2.9097 10,990 360 3,956,400
reports....................................
Sec. 312.38(b) and (c); notifications of 1,549 1.834 2,841 28 79,548
withdrawal of an IND.......................
Sec. 312.145; Guidance Documents:
Establishment and Operation of Clinical 37 32.027 1,185 1.515 1,795
Trial Data Monitoring Committees (2006)
Special Protocol Assessment (2018)-- 106 1.78 189 8 1,510
Notification for Carcinogenicity
Protocols..............................
Requests for Special Protocol Assessment 113 1.03 116 15 1,740
Reports................................
-------------------------------------------------------------------
Subtotal Subpart B CDER............. ........... .............. 101,751 ........... 20,220,727
----------------------------------------------------------------------------------------------------------------

[[Page 12426]]

Subpart C--Administrative Actions: Sec. Sec. 312.40 through 312.48
----------------------------------------------------------------------------------------------------------------
Sec. 312.42; clinical holds and requests 181 1.28 232 284 65,888
for modifications..........................
Sec. 312.44(c) and (d); sponsor responses 1 1 1 16 16
to FDA when IND is terminated..............
Sec. 312.45(a) and (b); sponsor requests 213 1.72 367 12 4,404
for or responses to an inactive status
determination of an IND by FDA.............
Sec. 312.47; meetings, including ``End-of- 174 2.885 502 160 80,320
Phase 2'' meetings and ``Pre-NDA'' meetings
-------------------------------------------------------------------
Subtotal Subpart C CDER................. ........... .............. 1,102 ........... 150,628
----------------------------------------------------------------------------------------------------------------
Subpart D--Responsibilities of Sponsors and Investigators
----------------------------------------------------------------------------------------------------------------
Sec. 312.54(a); sponsor submissions to FDA 7 1.14 8 48 384
concerning investigations involving an
exception from informed consent under Sec.
50.24.....................................
Sec. 312.54(b); sponsor notifications to 2 1 2 48 96
FDA and others concerning an institutional
review board determination that it cannot
approve research because it does not meet
the criteria in the exception from informed
consent in Sec. 50.24(a).................
Sec. 312.56; review of ongoing 4,570 5.4689 24,993 80 1,999,440
investigations and associated notifications
Sec. 312.58; inspection of records and 73 1 73 8 584
reports by FDA.............................
Sec. 312.70; disqualification of a 5 1 5 40 200
clinical investigator by FDA...............
-------------------------------------------------------------------
Subtotal Subpart D CDER................. ........... .............. 25,081 ........... 2,000,704
----------------------------------------------------------------------------------------------------------------
Subpart F--Miscellaneous: Sec. Sec. 312.110 through 312.145
----------------------------------------------------------------------------------------------------------------
Sec. 312.110(b)(4) and (b)(5); written 8 22.375 179 75 13,425
certifications and written statements
submitted to FDA relating to the export of
an investigational drug....................
Sec. 312.120(b); submissions to FDA of 1,964 7.352 14,440 32 462,080
``supporting information'' related to the
use of foreign clinical studies not
conducted under an IND.....................
Sec. 312.120(c); waiver requests submitted 68 1.5 102 24 2,448
to FDA related to the use of foreign
clinical studies not conducted under an IND
Sec. 312.130; requests for disclosable 3 1 3 8 24
information in an IND and for
investigations involving an exception from
informed consent under Sec. 50.24........
Sec. 312.145; Guidance Documents:
Oversight of Clinical Investigations 88 1.5 132 4 528
(2013).................................
Pharmacogenomic Data Submissions (2005). 1 1 1 50 50
Adaptive Designs for Clinical Trials of 55 4.727 260 50 13,000
Drugs and Biologics (2019).............
E6(R2) Good Clinical Practice: 1,880 4.916 9,242 15.012 138,744
Integrated Addendum to ICH E6(R1)
(2018).................................
-------------------------------------------------------------------
Subtotal Subpart F CDER............. ........... .............. 24,359 ........... 630,299
-------------------------------------------------------------------
Sec. 300.200; Right to try reporting 10 1 10 2.5 25
requirements; submission of annual summary
report using Form FDA 5023.................
-------------------------------------------------------------------
Total................................... ........... .............. 152,856 ........... 23,016,423
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

Table 4--Estimated Annual Recordkeeping Burden for Human Drugs \1\
----------------------------------------------------------------------------------------------------------------
Number of Total
21 CFR section; activity Number of records per annual Average burden per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Subpart D--Responsibilities of Sponsors and Investigators
----------------------------------------------------------------------------------------------------------------
Sec. 312.52(a); transfer of 466 3.107 1,448 300.................... 434,400
obligations to a contract
research organization.
Sec. 312.57; records showing 13,000 1 13,000 100.................... 1,300,000
the receipt, shipment, or
other disposition of the
investigational drug and any
financial interests.
Sec. 312.62(a); records on 13,000 1 13,000 40..................... 520,000
disposition of drugs.
Sec. 312.62(b); records on 2,192 6.587 14,439 40..................... 577,560
case histories of individuals.
---------------------------------------------------------------------------------
Subtotal Subpart D CDER... .............. .............. 41,887 ....................... 2,831,960
----------------------------------------------------------------------------------------------------------------
Subpart G--Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests
----------------------------------------------------------------------------------------------------------------
Sec. 312.160(a)(3); records 547 1.43 782 0.50 (30 minutes)...... 391
pertaining to the shipment of
drugs for investigational use
in laboratory research
animals or in vitro tests.
Sec. 312.160(c); shipper 547 1.43 782 0.50 (30 minutes)...... 391
records of alternative
disposition of unused drugs.
---------------------------------------------------------------------------------
Subtotal.................. .............. .............. 1,564 ....................... 782
---------------------------------------------------------------------------------
Total................. .............. .............. 43,451 ....................... 2,832,742
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

Based on a review of the information collection since our last
request for OMB approval, we have retained the annual burden estimates
for the majority of these activities. However, our estimated burden for
the information

[[Page 12427]]

collection reflects an overall increase of 22 hours. We attribute the
increase to the correction of an inadvertent error in the reported
hours for 21 CFR 300.200, which requires the submission of an annual
report on Form FDA 5023 by sponsors and manufacturers who provide an
``eligible investigational drug'' under the Right to Try Act.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-04938 Filed 3-12-26; 8:45 am]
BILLING CODE 4164-01-P

</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>

View on FederalRegister.gov →Plain-text source

Indexed from Federal Register on March 13, 2026.

This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.