[Federal Register Volume 86, Number 187 (Thursday, September 30, 2021)]
[Notices]
[Pages 54208-54210]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21316]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-D-0368]
Investigator Responsibilities--Safety Reporting for
Investigational Drugs and Devices; Draft Guidance for Industry;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the availability of a draft guidance for industry entitled
``Investigator Responsibilities--Safety Reporting for Investigational
Drugs and Devices.'' The draft guidance provides recommendations to
help clinical investigators comply with the safety reporting
requirements of investigational new drug application (IND) studies and
investigational device exemption (IDE) studies. The guidance is
intended to help clinical investigators of drugs identify safety
information that is considered an unanticipated problem involving risk
to human subjects or others and that therefore requires prompt
reporting to institutional review boards (IRBs) and to help clinical
investigators of devices identify safety information that meets the
requirements for reporting unanticipated adverse device effects (UADEs)
to sponsors and to IRBs.
DATES: Submit either electronic or written comments on the draft
guidance by November 29, 2021 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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
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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-2021-D-0368 for ``Investigator Responsibilities--Safety Reporting
for Investigational Drugs and Devices.'' 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; 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; or
the Office of Policy, Guidance and Policy Development, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5431, 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, 301-796-3093,
[email protected]; 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; or
Maureen Dreher, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G216,
Silver Spring, MD 20993-0002, 301-796-2505.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Investigator Responsibilities--Safety Reporting for
Investigational Drugs and Devices.'' In the Federal Register of
September 29, 2010 (75 FR 59935), FDA published a final rule amending
the IND safety reporting requirements under 21 CFR part 312 and adding
safety reporting requirements for persons conducting bioavailability
(BA) and bioequivalence (BE) studies under 21 CFR part 320.
Subsequently, the 2012 final guidance for industry and investigators
entitled ``Safety Reporting Requirements for INDs and BA/BE Studies''
(December 2012) (the 2012 final guidance \1\) was published to help
sponsors and investigators comply with safety reporting requirements
for INDs and for IND-exempt BA/BE studies. Recently, the
recommendations for investigators provided in the 2012 final guidance
were updated, merged, and published for notice and comment purposes in
the draft guidance for industry entitled ``Sponsor Responsibilities--
Safety Reporting Requirements and Safety Assessment for IND and
Bioavailability/Bioequivalence Studies'' (June 2021) (the merged 2021
draft guidance).
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\1\ Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-reporting-requirements-inds-investigational-new-drug-applications-and-babe.
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The merged 2021 draft guidance does not, however, include the
recommendations for investigator responsibilities that are included in
the 2012 final guidance. Instead, the recommendations on the safety
reporting responsibilities of the investigator are the primary focus of
this draft guidance. Additionally, this draft guidance incorporates
concepts pertaining to investigator responsibilities for adverse event
reporting that are described in the guidance for clinical
investigators, sponsors, and IRBs entitled ``Adverse Event Reporting to
IRBs--Improving Human Subject Protection'' (January 2009) (the 2009
procedural final guidance \2\).
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\2\ Available at: https://www.fda.gov/media/72267/download.
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When finalized, this guidance will supersede corresponding sections
in the 2012 final guidance and the 2009 procedural final guidance.
Until that time, however, the 2012 final guidance and the 2009
procedural final guidance continue to represent FDA's current thinking
on investigator responsibilities for safety reporting for
investigational medical products.
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
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on ``Investigator Responsibilities--Safety Reporting for
Investigational Drugs and Devices.'' 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 56 have been approved under OMB control
number 0910-0130; the collections of information in 21 CFR part 312
have been approved under OMB control number 0910-0014; the collections
of information in 21 CFR part 320 have been approved under OMB control
number 0910-0672; and the collections of information in 21 CFR part 812
have been approved under OMB control number 0910-0078.
III. Electronic Access
Persons with access to the internet may obtain the draft 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/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: September 27, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21316 Filed 9-29-21; 8:45 am]
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