[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guidance finalizes the draft guidance of the same name published on 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