Notice2026-09543
Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Experience Reporting
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Published
May 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 postmarketing reporting and recordkeeping of adverse experiences for drug and biological products.
Full Text
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<title>Federal Register, Volume 91 Issue 92 (Wednesday, May 13, 2026)</title>
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[Federal Register Volume 91, Number 92 (Wednesday, May 13, 2026)]
[Notices]
[Pages 27065-27070]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-09543]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-3098]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Postmarketing Adverse Experience Reporting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 postmarketing reporting and recordkeeping
of adverse experiences for drug and biological products.
DATES: Either electronic or written comments on the collection of
information must be submitted by July 13, 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 July 13, 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-3098 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Postmarketing Adverse Experience
Reporting.'' 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#bbebe9fae8cfdaddddfbdddfda95d3d3c895dcd4cd"><span class="__cf_email__" data-cfemail="045456455770656262446260652a6c6c772a636b72">[email protected]</span></a>.
[[Page 27066]]
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.
Postmarketing Adverse Experience Reporting
OMB Control Number 0910-0230--Revision
This information collection helps support provisions found in
sections 201, 502, 505, 701, and 760 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 321, 352, 355, 371, and 379aa)
governing adverse experience reporting (AER) and associated
recordkeeping for FDA-regulated drug products. FDA has issued
applicable regulations in part 4 and Sec. Sec. 310.305, 314.80,
314.81, 314.98, and 329.100 (21 CFR part 4 and 21 CFR 310.305, 314.80,
314.81, 314.98, and 329.100) that implement the statutory requirements,
identify specific content and format elements, and establish reporting
and retention schedules for the required information. Postmarketing
safety data collection and adverse event reporting are critical
elements of FDA's monitoring of drugs. For more information, please
visit <a href="https://www.fda.gov/drugs/surveillance/postmarketing-adverse-event-reporting-compliance-program">https://www.fda.gov/drugs/surveillance/postmarketing-adverse-event-reporting-compliance-program</a>.
Respondents to the information collection are manufacturers,
packers, distributors, and applicants of FDA-regulated drug and
biologic products marketed with or without an FDA-approved application,
including over-the-counter (OTC) drug products marketed without an
approved application; OTC drug products marketed under the OTC Drug
Monograph Review process (whether subject to a final monograph or not);
and drug products marketed outside the monograph system. All reports
and followup reports must be submitted to FDA in electronic format,
although waivers of the electronic requirements are available for good
cause.
Adverse experience reporting for products associated with drug
marketing applications are governed by regulations in Sec. Sec.
314.80, 314.81, and 314.98. The regulations identify required reporting
content and format elements, as well as establish followup reporting
requirements and mandatory reporting schedules. The regulations also
establish associated recordkeeping and require that written procedures
be developed for the surveillance, receipt, evaluation, and reporting
of postmarketing adverse experiences to FDA. The regulations require
reporting in an electronic format that FDA can process, review, and
archive, although temporary waivers may be granted on a limited basis
for good cause. A final guidance for industry entitled ``Providing
Submissions in Electronic Format--Postmarketing Safety Reports'' (April
2022) is available for general information pertaining to electronic
submission of postmarketing safety reports for certain human drugs,
biological products, and combination products. The guidance is
available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-submissions-electronic-format-postmarketing-safety-reports">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-submissions-electronic-format-postmarketing-safety-reports</a>.
We have established and maintain the FDA Adverse Event Monitoring
System (AEMS), formerly the FDA Adverse Event Reporting System (FAERS).
The FDA AEMS Electronic Submissions web page is available at <a href="https://www.fda.gov/drugs/fda-adverse-event-monitoring-system-aems/fda-adverse-event-monitoring-system-aems-electronic-submissions">https://www.fda.gov/drugs/fda-adverse-event-monitoring-system-aems/fda-adverse-event-monitoring-system-aems-electronic-submissions</a>. Information may be
submitted via FDA's Electronic Submissions Gateway Next Generation or
utilizing the FDA Safety Reporting Portal, developed by FDA and the
National Institutes of Health to streamline reporting and review of
adverse events.
The primary purpose of FDA's adverse drug experience reporting
system is to enable identification of signals for potentially serious
safety problems with marketed drugs. Although premarket testing
discloses a general safety profile of a new drug's comparatively common
adverse effects, the larger and more heterogenous patient populations
exposed to the marketed product provide the opportunity to collect
information on rare, latent, and long-term effects. Data that
contribute to signals are obtained from a variety of sources, including
reports from patients, treating physicians, foreign regulatory
agencies, clinical investigators, and literature. Information derived
from the adverse drug experience reporting system contributes directly
to increased public health protection because the information enables
FDA to make important changes to the product's labeling (such as adding
a new warning), to make decisions about risk evaluation and mitigation
strategies; to determine the need for postmarketing studies or clinical
trials; and, when necessary, to initiate removal of a product from the
market.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden 1 2 3
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Number of
21 CFR section or guidance; Number of responses per Total annual Average burden Total hours
activity respondents respondent responses per response
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310.305(c)(5); AERs for 36 88.8 3,197 1 3,197
prescription products not the
subject of a marketing
application....................
314.80(c)(1); 15-day alerts for 682 1,832.84 1,250,000 1 1,250,000
approved products..............
[[Page 27067]]
314.80(c)(2); ICSRs for serious, 682 1,228.73 838,000 1 838,000
expected, and nonserious
adverse drug experiences.......
314.80(c)(2); periodic reports 682 33.72 23,000 60 1,380,000
for approved products..........
329.100; AERs for non- 312 62.522 19,507 6 117,042
prescription drug products.....
ICH E2C(R2) Guidance; Periodic 471 8.885 4,185 1 4,185
safety updates; Applicants with
waiver for an approved
application (section III.A.)...
ICH E2C(R2) Guidance; Periodic 1,115 16.254 18,123 2 36,246
safety updates; Applicants with
no waiver for an approved
application (section III.B.)...
AER During Pandemic Guidance; 1 1 1 8 8
notifying FDA when normal
reporting is not feasible
(section III.C.)...............
4.102, 4.103, 4.104, 4.105, 1 1 1 24 24
310.305, 314.80, 314.98,
329.100(c); Waiver requests
from electronic reporting
requirements...................
Best Practices for FDA Staff in 1 23 23 1 23
the Postmarketing Safety
Surveillance of Human Drug and
Biological Products; Use of a
targeted data collection tool
to gather detailed case
information specific to the
product (section 9.4.).........
Best Practices for FDA Staff in 12 55 660 0.1 66
the Postmarketing Safety
Surveillance of Human Drug and
Biological Products;
Expeditiously submit AERs of
interest beyond minimum
reporting requirements (section
9.4.)..........................
Best Practices for FDA Staff in 15 4 60 15 900
the Postmarketing Safety
Surveillance of Human Drug and
Biological Products; Summarize
and assess AERs of interest at
a frequency defined by FDA
(e.g., in periodic safety
reports or in some other form)
(section 9.4.).................
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Total....................... .............. .............. 2,156,757 .............. 3,629,691
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\1\ There are no capital costs associated with this collection. The operating and maintenance costs associated
with this collection of information are approximately $25,000 annually.
\2\ The reporting burdens for Sec. 310.305(c)(1), (2), and (3), and voluntary reports by healthcare providers
received under Sec. Sec. 314.80(c)(1)(i) and (ii) are covered under OMB control number 0910-0291.
\3\ Totals may not sum due to rounding.
Table 2--Estimated Annual Recordkeeping Burden \1\ \2\
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Number of
21 CFR section or guidance section; activity Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
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310.305; AER records--prescription product 36 88.8 3,197 16........................................ 51,152
not the subject of a marketing application.
314.80(j); AER records--product associated w/ 841 1,814.0606 1,525,625 16........................................ 24,410,000
marketing application.
Postmarket AER for Nonprescription Drug 312 62.5224 19,507 8......................................... 156,056
Products Guidance; (Sec. 329.100).
AERs During Pandemic Guidance; Continuity of 100 1 100 50........................................ 5,000
operations planning (section III.B.).
AERs During Pandemic Guidance; documenting 350 1 350 8......................................... 2,800
conditions and resultant high absenteeism
(section III.C.2).
AERs During Pandemic Guidance; documenting 350 1 350 8......................................... 2,800
AER process (section III.C.1.).
4.105; Postmarketing safety recordkeeping 11 18 198 0.1 (6 minutes)........................... 20
for combination products and constituent
parts.
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Total................................... .............. .............. 1,549,327 .......................................... 24,627,828
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\1\ There are no capital costs associated with this collection of information. There are operating and maintenance costs associated with this collection
of information of approximately $22,000 annually.
\2\ Totals may not sum due to rounding.
[[Page 27068]]
Table 3--Estimated Annual Third-Party Disclosure Burden \1\ \2\
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Number of
21 CFR section; activity Number of disclosures Total annual Average burden per disclosure Total hours
respondents per respondent disclosures
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4.103; Postmarketing Safety reporting for 11 18 198 0.35 (21 minutes)......................... 69
combination products--Sharing information
with other constituent part applicants.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Totals may not sum due to rounding.
Our estimates of the number of respondents and the total annual
responses are based on reports submitted to the Agency. All applicants
who have received marketing approval for drug products (including
combination products that are administered as drug products) are
required to report serious, unexpected adverse drug experiences (15-day
``Alert reports'') (Sec. 314.80(c)(1)(i)), as well as followup reports
(Sec. 314.80(c)(1)(ii)) to FDA. These include all foreign or domestic
AERs as well as AERs based on information from applicable scientific
literature and certain reports from post marketing studies. Section
314.80(c)(1)(iii) pertains to AERs submitted by nonapplicants. This
information collection and burden table includes all 15-day alert
reports submitted by applicants, manufacturers, packers, and
distributors. Voluntary reports from healthcare providers are included
under OMB control number 0910-0291.
Under Sec. 314.80(c)(2), applicants (including combination
products that are administered as drug products) must also provide
periodic reports of adverse drug experiences. For the reporting
interval, a periodic report includes reports of serious, expected
adverse drug experiences, all nonserious adverse drug experiences, and
an index of these reports; a narrative summary and analysis of adverse
drug experiences; an analysis of the 15-day Alert reports submitted
during the reporting interval; and a history of actions taken because
of adverse drug experiences. Under Sec. 314.80(j), applicants must
keep records of all adverse drug experience reports known to the
applicant for 10 years.
For marketed prescription drug products without approved new drug
applications (NDAs) or abbreviated new drug applications (ANDAs),
manufacturers, packers, and distributors of these products are required
to report to FDA serious, unexpected adverse drug experiences as well
as followup reports (Sec. 310.305(c)). Section 310.305(c)(5) pertains
to the submission of followup reports to reports forwarded to the
manufacturers, packers, and distributors by FDA. Under Sec.
310.305(g), each manufacturer, packer, and distributor shall maintain
records of all adverse drug experiences required to be reported for 10
years. All 15-day Alert reports and followup reports must be submitted
to FDA in electronic format.
Section 760 of the FD&C Act also provides for mandatory safety
reporting for over-the-counter human drug products not subject to
applications approved under section 505 of the FD&C Act (NDAs or
ANDAs). These requirements apply to all OTC drug products marketed
without an approved application, including those marketed under the OTC
Drug Monograph Review process (whether or not subject to a final
monograph), those marketed outside the monograph system, and including
those that have been discontinued from marketing but for which a report
of an adverse event was received. Under Sec. 329.100, respondents must
submit reports according to section 760 of the FD&C Act in an
electronic format.
To assist respondents with implementation of section 760 of the
FD&C Act, FDA developed the guidance for industry entitled
``Postmarketing Adverse Event Reporting for Nonprescription Human Drug
Products Marketed Without an Approved Application,'' (July, 2009)
available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarketing-adverse-event-reporting-nonprescription-human-drug-products-marketed-without-approved">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarketing-adverse-event-reporting-nonprescription-human-drug-products-marketed-without-approved</a>. The
guidance document discusses what should be included in a serious
adverse drug event report submitted under section 760(b)(1) of the FD&C
Act, including how to submit these reports and followup reports under
section 760(c)(2) of the FD&C Act. Section 760(e) of the FD&C Act also
requires that responsible persons maintain records of nonprescription
drug adverse event reports, whether the event is serious or not, for a
period of 6 years. FDA's guidance recommends that respondents maintain
records of efforts to obtain the minimum data elements for a report of
a serious adverse drug event and any followup reports.
In addition, this information collection includes an International
Council for Harmonisation of Technical Requirements for Pharmaceuticals
for Human Use (ICH) guidance for industry entitled ``Providing
Postmarketing Periodic Safety Reports in the ICH E2C(R2) Format
(Periodic Benefit-Risk Evaluation Report), (November 2016)'' available
at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-postmarket-periodic-safety-reports-ich-e2cr2-format-periodic-benefit-risk-evaluation">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-postmarket-periodic-safety-reports-ich-e2cr2-format-periodic-benefit-risk-evaluation</a>. The ICH E2C(R2) guidance
describes the conditions under which applicants may use the ICH E2C(R2)
Periodic Benefit-Risk Evaluation Report format for certain types of
adverse event reporting.
FDA regulations in Sec. Sec. 314.80(c)(2) and 600.80(c)(2) require
applicants to submit postmarketing periodic safety reports for each
approved application. The reports must be submitted quarterly for the
first 3 years following the U.S. approval date and annually thereafter
and must contain the information described in Sec. Sec.
314.80(c)(2)(ii) and 600.80(c)(2)(ii) (the information collection
associated with 21 CFR part 600--Biological Products, is approved under
OMB control number 0910-0308). The Agency guidance assists respondents
with satisfying the regulatory requirements in an alternative format,
noting that the process differs depending on whether an applicable
periodic safety update report waiver is in place.
Similarly, this information collection accounts for burden that may
be applicable to the guidance document, ``Postmarketing Adverse Event
Reporting for Medical Products and Dietary Supplements During a
Pandemic (May 2020),'' available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarketing-adverse-event-reporting-medical-products-and-dietary-supplements-during-pandemic">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarketing-adverse-event-reporting-medical-products-and-dietary-supplements-during-pandemic</a>.
[[Page 27069]]
In response to the Coronavirus Disease 2019 public health emergency, we
revised the Agency guidance document to provide recommendations for
recordkeeping applicable to any pandemic, not just influenza, including
recommendations for planning, notification, and documentation for
continuity of operations for firms that report postmarketing adverse
events during any pandemic.
We include burden attributable to provisions related to
postmarketing safety reporting for combination products as outlined in
21 CFR part 4, subpart B. When information regarding an event that
involves a death or serious injury, or an adverse event, associated
with the use of a combination product that includes a drug product, is
received by the product applicant, the information must be provided to
the other constituent part applicant(s) no later than 5 calendar days
after receipt under Sec. 4.103 (21 CFR 4.103). Relatedly, 21 CFR 4.104
explains how and where to submit reports for combination products, and
21 CFR 4.105 provides for associated recordkeeping. For combination
products that are administered as drug products with a constituent
part, adverse event reports are submitted to the drug application under
21 CFR part 314, and constituent applicants are notified of the AER
under Sec. 4.103. These provisions are also described in the guidance
document ``Postmarketing Safety Reporting for Combination Products''
(July 2019), available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarketing-safety-reporting-combination-products">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarketing-safety-reporting-combination-products</a>.
We are revising this information collection to account for burden
that may be attributable to the best practice document entitled ``Best
Practices for FDA Staff in the Postmarketing Safety Surveillance of
Human Drug and Biological Products'' (January 2024), available at
<a href="https://www.fda.gov/media/130216/download">https://www.fda.gov/media/130216/download</a>. The best practice document
describes enhanced pharmacovigilance activities which FDA may request
of an applicant. For a specific product, these activities may include
use of a targeted data collection tool to gather detailed case
information regarding adverse experiences of interest, expeditious
submission of adverse experiences of interest beyond minimum reporting
requirements, and/or summarization and assessment of adverse
experiences of interest at a frequency defined by FDA. Accordingly, we
are revising this information collection to include burden in Table 1,
rows 10 through 12, that we attribute to the enhanced pharmacovigilance
activities regarding a subset of adverse experience reports (adverse
experiences of interest) which include submitting adverse experiences
which would otherwise be submitted within a different timeframe,
utilizing a targeted data collection tool for those adverse experiences
and/or providing a summary and assessment of those adverse experiences
for human drug and biological products. In addition, we revised Table
1, rows 3 and 4, to more accurately describe the two types of reports
that are submitted under 314.80(c)(2). In doing so, we corrected an
overreporting. We estimate no increase in the recordkeeping burden
associated with enhanced pharmacovigilance activities because, although
the reported contents or timeline may change slightly, the
recordkeeping burden associated with the reporting vehicle remains
unchanged.
We are also revising this information collection to account for the
mandatory electronic submission of individual case safety reports
(ICSRs) for drugs, biologics, and combination products using the data
standards specified in the ICH E2B(R3) guideline when submitting ICSRs
via the Electronic Submissions Gateway Next Generation (ESG NextGen).
FDA adopted the ICH Implementation Guide (IG) for Electronic
Transmission of Individual Case Safety Reports (ICSRs): E2B(R3) Data
Elements and Message Specification (ICH ICSR IG) in February 2014. At
present, FDA allows submitters to voluntarily use the E2B(R3) data
standards in their ESG NextGen submissions. In January 2024, FDA began
accepting electronic submissions of postmarketing ICSRs for human drug
products, biological products, and drug- or biologic-led combination
products submitted to AEMS via the ESG NextGen in electronic format
using the ICH E2B(R3) data standards and announced that submitters
could continue to submit using E2B(R2) standards for an additional two
years during the E2B(R3) implementation period. On April 6, 2026, we
announced that to facilitate implementation and enhance efficiency and
alignment with internationally harmonized data standards, we are
requiring that ICSRs submitted through ESG NextGen must be in the ICH
E2B(R3) data standards beginning on October 1, 2026, unless earlier
transition to ICH E2B(R3) data standards is needed to accommodate
reporting requirements (see, for example, 21 CFR 314.81(b)(3)(v), added
by the final rule entitled ``Nonprescription Drug Product With an
Additional Condition for Nonprescription Use'' (89 FR 105288, December
26, 2024)). See: <a href="https://www.federalregister.gov/documents/2026/04/06/2026-06660/electronic-submission-of-postmarketing-individual-case-safety-reports-to-the-food-and-drug">https://www.federalregister.gov/documents/2026/04/06/2026-06660/electronic-submission-of-postmarketing-individual-case-safety-reports-to-the-food-and-drug</a>.
The information provided by the ICH E2B(R3) standard is needed to
improve the quality of data in ICSR submissions. We use the information
to enable improved handling and analyses of ICSRs. Differences between
ICH E2B(R2) and ICH E2B(R3) include, for example: new, changed, and
expanded data elements; assessment of seriousness at the event level,
rather than the case level; and embedding of attachments in the ICSR
rather than providing separately.
We announced the adoption of the ICH E2B(R3) standard in February
2014 (79 FR 9908). In June of 2014, we amended our postmarketing safety
reporting regulations for human drug and biological products to require
that persons subject to mandatory reporting requirements submit safety
reports in an electronic format that FDA can process, review, and
archive (79 FR 33072). This revision reaffirmed our intention to
continue to rely on ICH standards while also providing other options
for providing electronic submissions to FDA. In this revision, we
stated that it has been FDA's practice to accept both the latest
version of the ICH E2B standard in addition to the previous version to
allow applicants reasonable time to transition to the updated ICH E2B
standard. In this revision, we also stated that further changes to
submission standards will be provided in guidance, as appropriate. In
January 2024, we provided a transition period allowing voluntary use of
the ICH E2B(R3) standard to minimize burden resulting from changes to
the ICSR format. The purpose of the 2014 announcement and the 2024
transition period was to mitigate burden by allowing respondents time
to implement changes to their submission systems. We note that many
respondents that use the ESG NextGen are global industry participants
and may have already adopted the ICH E2B(R3) standard for their
submissions. Therefore, we believe that there is no change in the
estimated burden associated with ICSR submissions over the ESG NextGen.
Accordingly, we seek OMB approval of the mandatory implementation of
the ICH E2B(R3) standard.
This information collection incorporates revisions to include the
best practice document entitled ``Best Practices for FDA Staff in the
[[Page 27070]]
Postmarketing Safety Surveillance of Human Drug and Biological
Products'' and its enhanced pharmacovigilance activities and to correct
an unrelated overreporting error. We are otherwise retaining the burden
hour estimates approved by OMB in this collection on July 31, 2025. As
a result of this revision, the total burden hours of the information
collection have decreased by 48,061,011 hours and increased by 23,743
responses.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-09543 Filed 5-12-26; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on May 13, 2026.
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