Notice2021-13684
Sponsor Responsibilities-Safety Reporting Requirements and Safety Assessment for Investigational New Drug Application and Bioavailability/Bioequivalence Studies; Draft Guidance for Industry; Availability
Primary source
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Published
June 28, 2021
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Sponsor Responsibilities--Safety Reporting Requirements and Safety Assessment for Investigational New Drug Application and Bioavailability/ Bioequivalence Studies." The draft guidance provides recommendations for sponsors and sponsor-investigators to comply with the requirements of investigational new drug application (IND) safety reporting and safety reporting for bioavailability (BA) and bioequivalence (BE) studies. In doing so, the guidance provides recommendations related to the two IND safety reporting provisions that require assessment of aggregate data to facilitate appropriate IND safety reporting practices. An earlier draft guidance for industry entitled "Safety Assessment for IND Safety Reporting" (December 2015) (the 2015 draft guidance) has been incorporated into this draft guidance. However, this content was revised to address feedback from stakeholders and comments received on the 2015 draft guidance. Concurrent with the publication of this draft guidance, we are withdrawing the 2015 draft guidance. Additionally, this draft guidance incorporates content from the final guidance for industry and investigators entitled "Safety Reporting Requirements for INDs and BA/BE Studies" (December 2012) (the 2012 final guidance). This incorporated content remains largely unchanged in this draft guidance.
Full Text
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<title>Federal Register, Volume 86 Issue 121 (Monday, June 28, 2021)</title>
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[Federal Register Volume 86, Number 121 (Monday, June 28, 2021)]
[Notices]
[Pages 34020-34022]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-13684]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-D-2099]
Sponsor Responsibilities--Safety Reporting Requirements and
Safety Assessment for Investigational New Drug Application and
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 ``Sponsor
Responsibilities--Safety Reporting Requirements and Safety Assessment
for Investigational New Drug Application and Bioavailability/
Bioequivalence Studies.'' The draft guidance provides recommendations
for sponsors and sponsor-investigators to comply with the requirements
of investigational new drug application (IND) safety reporting and
safety reporting for bioavailability (BA) and bioequivalence (BE)
studies. In doing so, the guidance provides recommendations related to
the two IND safety reporting provisions that require assessment of
aggregate data to facilitate appropriate IND safety reporting
practices. An earlier draft guidance for industry entitled ``Safety
Assessment for IND Safety Reporting'' (December 2015) (the 2015 draft
guidance) has been incorporated into this draft guidance. However, this
content was revised to address feedback from stakeholders and comments
received on the 2015 draft guidance. Concurrent with the publication of
this draft guidance, we are withdrawing the 2015 draft guidance.
Additionally, this draft guidance incorporates content from the final
guidance for industry and investigators entitled ``Safety Reporting
Requirements for INDs and BA/BE Studies'' (December 2012) (the 2012
final guidance). This incorporated content remains largely unchanged in
this draft guidance.
DATES: Submit either electronic or written comments on the draft
guidance by September 27, 2021 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.
[[Page 34021]]
<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-2020-D-2099 for ``Sponsor Responsibilities--Safety Reporting
Requirements and Safety Assessment for Investigational New Drug
Application and Bioavailability/Bioequivalence 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: Paul Gouge, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6328, Silver Spring, MD 20993-0002, <a href="/cdn-cgi/l/email-protection#e8abacadbaa7a5b8a88e8c89c680809bc68f879e"><span class="__cf_email__" data-cfemail="82c1c6c7d0cdcfd2c2e4e6e3aceaeaf1ace5edf4">[email protected]</span></a>;
or Stephen Ripley, 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 draft guidance for industry
entitled ``Sponsor Responsibilities--Safety Reporting Requirements and
Safety Assessment for Investigational New Drug Application and
Bioavailability/Bioequivalence Studies.'' The draft guidance provides
recommendations for sponsors and sponsor-investigators to facilitate
compliance with the requirements of IND safety reporting and safety
reporting for BA and BE studies under Sec. Sec. 312.32 and
320.31(d)(3) (21 CFR 312.32 and 320.31(d)(3)). In doing so, the draft
guidance provides recommendations for sponsors related to the two IND
safety reporting provisions (Sec. 312.32(c)(1)(i)(C) and (iv)) that
require assessment of aggregate data to facilitate appropriate IND
safety reporting practices. More generally, it provides sponsors and
sponsor-investigators recommendations regarding expedited safety
reporting requirements for human drug and biological products that are
being investigated under an IND and for drugs that are the subject of
BA and BE studies that are exempt from the IND requirements.
In the Federal Register of December 17, 2015 (80 FR 78743), FDA
announced the availability of the 2015 draft guidance entitled ``Safety
Assessment for IND Safety Reporting.'' FDA received numerous comments
on the 2015 draft guidance, and these comments were carefully
considered and addressed by FDA in this draft guidance. Noteworthy
changes include revised recommendations on the following: (1) Planned
unblinding of safety data and implications for trial integrity, (2)
increased flexibility regarding the party reviewing safety information
across a development program for IND safety reporting purposes, (3)
clarification regarding the scope and methodology for aggregate
analyses, and (4) clarification regarding the plan for safety
surveillance, including what elements should be included in the plan.
Accordingly, concurrent with the publication of this draft guidance, we
are withdrawing the 2015 draft guidance.
Further, this draft guidance incorporates content from the 2012
final guidance entitled ``Safety Reporting Requirements for INDs and
BA/BE Studies''. The content from the 2012 final guidance remains
largely unchanged in this draft guidance; however, this draft guidance
does not incorporate the investigator provisions of the 2012 final
guidance. FDA intends to publish a separate draft guidance on
investigator's responsibilities for safety reporting for human drug and
biological products that are being investigated under an IND.
When this draft guidance and the draft guidance on investigator's
responsibilities for IND safety reporting are finalized, FDA plans to
withdraw the 2012 final guidance. However, until FDA finalizes these
two draft guidances, the 2012 final guidance remains in effect and
represents FDA's current thinking.
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 ``Sponsor
Responsibilities--Safety Reporting Requirements and Safety Assessment
for Investigational New Drug Application and Bioavailability/
Bioequivalence 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
[[Page 34022]]
OMB under the PRA. The collections of information in 21 CFR parts 312
and 320 have been approved under OMB control number 0910-0014.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at <a href="https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm">https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm</a>, <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</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: June 22, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13684 Filed 6-25-21; 8:45 am]
BILLING CODE 4164-01-P
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