[Federal Register Volume 89, Number 64 (Tuesday, April 2, 2024)]
[Notices]
[Pages 22728-22729]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06726]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-1173]


Electronic Submission of Expedited Safety Reports From 
Investigational New Drug-Exempt Bioavailability/Bioequivalence Studies; 
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 ``Electronic 
Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies.'' 
This guidance provides instructions for the electronic submission of 
expedited individual case safety reports (ICSRs) from investigational 
new drug (IND)-exempt bioavailability (BA)/bioequivalence (BE) studies 
to the FDA Adverse Event Reporting System (FAERS). This guidance 
finalizes the draft guidance entitled ``Electronic Submission of 
Expedited Safety Reports From IND-Exempt BA/BE Studies'' issued on 
August 3, 2022.

DATES: The announcement of the guidance is published in the Federal 
Register on April 2, 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-2022-D-1173 for ``Electronic Submission of Expedited Safety Reports 
from IND-Exempt BA/BE Studies.'' 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.

[[Page 22729]]

     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. 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: Susan Levine, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 1674, Silver Spring, MD 20993-0002, 240-
402-7936, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Electronic Submission of Expedited Safety Reports from IND-
Exempt BA/BE Studies.'' This guidance provides instructions for the 
electronic submission of expedited ICSRs from IND-exempt BA/BE studies 
to FAERS. An ICSR captures information necessary to support the 
reporting of an adverse event related to an individual subject that is 
associated with the use of an FDA-regulated product.\1\ The electronic 
submission of the ICSRs from IND-exempt BA/BE studies is a voluntary 
option for submitting these required reports.
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    \1\ See additional information on Individual Case Safety Reports 
available at https://www.fda.gov/industry/fda-resources-data-standards/individual-case-safety-reports.
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    In the Federal Register of September 29, 2010 (75 FR 59935), FDA 
published a final rule that revised the IND safety reporting 
requirements for human drug and biological products under 21 CFR 312 
and added safety reporting requirements for persons conducting IND-
exempt BA/BE studies under Sec.  320.31 (21 CFR 320.31).\2\ A serious 
adverse event experienced by a study subject during the conduct of an 
IND-exempt BA/BE study must be submitted on Form FDA 3500A or in an 
electronic format that FDA can process, review, and archive.\3\
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    \2\ BA and BE studies that meet the conditions for exemption 
under 21 CFR 320.31 are not conducted under an IND and are not 
subject to the IND safety reporting requirements. The safety 
reporting requirements under Sec.  320.31(d)(3) apply to persons 
conducting BA or BE studies that are exempt from the IND 
requirements.
    \3\ Sec.  320.31(d)(3).
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    Previously, to meet the requirements under Sec.  320.31(d)(3) 
applicable to IND-exempt BA/BE studies, submitters sent expedited 
premarket safety reports directly to the Office of Generic Drugs (OGD) 
by email, telephone, or facsimile. This guidance provides 
recommendations on how to electronically submit ICSRs to FAERS as an 
alternate avenue for submitting reports to OGD.
    This guidance finalizes the draft guidance entitled ``Electronic 
Submission of Expedited Safety Reports from IND-Exempt BA/BE Studies'' 
issued on August 3, 2022 (87 FR 47431). FDA did not receive any 
comments to the docket. Editorial changes were made to improve clarity 
and incorporate the FAERS enhancements to enable electronic submissions 
of ICSRs from IND-exempt BA/BE studies.
    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 ``Electronic Submission of Expedited Safety 
Reports from IND-Exempt BA/BE Studies.'' 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 
in 21 CFR part 312 for IND applications and 21 CFR 320.31 for IND-
exempt BA/BE safety reporting requirements for human drug and 
biological products have been approved under OMB control number 0910-
0014. The collections of information in 21 CFR 314 for safety report 
submissions for applications for FDA approval new drug application have 
been approved under OMB control number 0910-0001.

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/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: March 26, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-06726 Filed 4-1-24; 8:45 am]
BILLING CODE 4164-01-P