Notice2022-16599
Electronic Submission of Expedited Safety Reports From Investigational New Drug-Exempt Bioavailability/Bioequivalence Studies; Draft Guidance for Industry; Availability
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Published
August 3, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies."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 through the FDA Adverse Event Reporting System (FAERS) database.
Full Text
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<title>Federal Register, Volume 87 Issue 148 (Wednesday, August 3, 2022)</title>
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[Federal Register Volume 87, Number 148 (Wednesday, August 3, 2022)]
[Notices]
[Pages 47431-47432]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-16599]
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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;
Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Electronic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
through the FDA Adverse Event Reporting System (FAERS) database.
DATES: Submit either electronic or written comments on the draft
guidance by October 3, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
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-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 <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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the draft 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 draft 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, <a href="/cdn-cgi/l/email-protection#40133533212e6e0c2536292e25002624216e2828336e272f36"><span class="__cf_email__" data-cfemail="bfeccaccded191f3dac9d6d1daffd9dbde91d7d7cc91d8d0c9">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft 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
through the FAERS database. 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.
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\1\ See additional information on Individual Case Safety Reports
available at <a href="https://www.fda.gov/industry/fda-resources-data-standards/individual-case-safety-reports">https://www.fda.gov/industry/fda-resources-data-standards/individual-case-safety-reports</a>.
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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
[[Page 47432]]
IND-exempt BA/BE studies under 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\ 21 CFR 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 the FAERS
database as an alternate avenue for submitting reports to OGD once
these enhancements are activated.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent 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. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. 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 draft guidance
at <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: July 29, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-16599 Filed 8-2-22; 8:45 am]
BILLING CODE 4164-01-P
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