[Federal Register Volume 86, Number 121 (Monday, June 28, 2021)]
[Notices]
[Pages 34020-34022]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Bioavailability/Bioequivalence Studies; Draft Guidance for Industry; 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the availability of a draft guidance for industry entitled ``Sponsor 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 The draft guidance provides recommendations 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 An earlier draft guidance for industry entitled ``Safety 
Assessment for IND Safety Reporting'' (December 2015) (the 2015 draft 
guidance) has been incorporated into this draft guidance.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received on the 2015 draft guidance.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this draft guidance, we are withdrawing the 2015 draft guidance. 
Additionally, this draft guidance incorporates content from the final 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this draft guidance.

DATES: Submit either electronic or written comments on the draft 
guidance by September 27, 2021 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
     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.

[[Page 34021]]

     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 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 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, [email protected]; 
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 https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, 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: June 22, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13684 Filed 6-25-21; 8:45 am]
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