Providing Regulatory Submissions in Electronic Format: Investigational New Drug Application Safety Reports; Guidance for Industry; Availability
| Published date | 01 April 2024 |
| Record Number | 2024-06736 |
| Citation | 89 FR 22410 |
| Court | Food And Drug Administration |
| Section | Notices |
Federal Register, Volume 89 Issue 63 (Monday, April 1, 2024)
[Federal Register Volume 89, Number 63 (Monday, April 1, 2024)]
[Notices]
[Pages 22410-22412]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06736]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-3953]
Providing Regulatory Submissions in Electronic Format:
Investigational New Drug Application Safety Reports; Guidance for
Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Providing
Regulatory Submissions in Electronic Format: IND Safety Reports.'' This
guidance finalizes the draft guidance of the same name published on
October 30, 2019, and describes the electronic format sponsors will be
required to use when they electronically submit investigational new
drug application (IND) safety reports to the Center for Drug Evaluation
and Research (CDER) or the Center for Biologics Evaluation and Research
(CBER) for serious and unexpected suspected adverse reactions, as
required by FDA regulations. FDA is establishing the electronic format
requirements described in this guidance under the Federal Food, Drug,
and Cosmetic Act
[[Page 22411]]
(FD&C Act). The requirements in the guidance will be effective 24
months after the date of publication (April 1, 2026). Certain sponsors
will be required to submit the specified IND safety reports
electronically to FDA using the FDA Adverse Event Reporting System
(FAERS) as structured data elements, which will provide sponsors with a
reporting format that is consistent with the International Council for
Harmonisation (ICH) E2B format guidelines and reporting requirements to
other regulatory agencies.
DATES: The announcement of the guidance is published in the Federal
Register on April 1, 2024.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
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-2019-D-3953 for ``Providing Regulatory Submissions in Electronic
Format: IND Safety Reports.'' Received comments 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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Suranjan De, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4307, Silver Spring, MD 20993-0002, 240-
402-0498; or James Myers, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993-0002, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a final guidance for industry
entitled ``Providing Regulatory Submissions in Electronic Format: IND
Safety Reports.'' This guidance finalizes the draft guidance of the
same name published on October 30, 2019 (84 FR 58158), and describes
the electronic format sponsors will be required to use when they
electronically submit IND safety reports to CDER and CBER for serious
and unexpected suspected adverse reactions, as required under 21 CFR
312.32(c)(1)(i). FDA is establishing the electronic format requirements
described in this final guidance under section 745A(a) of the FD&C Act
(21 U.S.C. 379k-1(a)). Certain sponsors will be required to submit the
specified IND safety reports electronically to FDA using FAERS as
structured data elements. This will provide sponsors with a reporting
format that is consistent with the ICH E2B format guidelines and
reporting requirements to other regulatory agencies. Additional
technical specification documents and instructions for submitting IND
safety reports, including ``Electronic Submission of IND Safety Reports
Technical Conformance Guide'' and the technical specifications document
entitled ``Technical Specifications Document--FDA Regional
Implementation Guide for E2B(R3) Electronic Transmission of Individual
Case Safety Reports for Drug and Biological Products,'' are available
on the FDA Adverse Event Reporting System (FAERS) Electronic
Submissions--E2B(R3) Standards web page (available at: https://
www.fda.gov/
[[Page 22412]]
drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/
fda-adverse-event-reporting-system-faers-electronic-submissions-e2br3-
standards).
The electronic format requirements specified in this guidance will
be effective 24 months after the publication of this guidance (April 1,
2026). Before the effective date of this requirement, FDA will accept
the IND safety reports described in this guidance to FAERS as part of a
voluntary submission program.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Providing Regulatory Submissions in
Electronic Format: IND Safety Reports.'' It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
under 21 CFR 312.10 for submitting waiver requests and in 21 CFR 312.32
for submitting IND safety reports and reporting serious and unexpected
suspected adverse events have been approved under OMB control number
0910-0014. The collections of information for submitting Forms FDA 3500
and 3500A, and for FDA adverse event reporting and electronic
submissions using the Electronic Submission Gateway and the Safety
Reporting Portal have been approved under OMB control number 0910-0291.
The collections of information for submitting periodic adverse drug
experience reports have been approved under OMB control number 0910-
0230. The collections of information for submitting FAERS reports have
been approved under 0910-0308.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances,
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: March 25, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-06736 Filed 3-29-24; 8:45 am]
BILLING CODE 4164-01-P
