Document ID: FDA-2021-D-0368-0001
Agency: fda
Document Type: Notice
Title: Investigator Responsibilities—Safety
Reporting for Investigational Drugs
and Devices; Draft Guidance for
Industry; Availability
Posted Date: 2021-09-30T04:00Z

[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]

-----------------------------------------------------------------------

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Investigational Drugs and Devices; Draft Guidance for Industry; 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.

-----------------------------------------------------------------------

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the availability of a draft guidance for industry entitled 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 The draft guidance provides recommendations to 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DATES: Submit either electronic or written comments on the draft 
guidance by November 29, 2021 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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

[[Page 54209]]

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, 
paul.gouge@fda.hhs.gov; 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).
---------------------------------------------------------------------------

    \1\ Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-reporting-requirements-inds-investigational-new-drug-applications-and-babe.
---------------------------------------------------------------------------

    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\).
---------------------------------------------------------------------------

    \2\ Available at: https://www.fda.gov/media/72267/download.
---------------------------------------------------------------------------

    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

[[Page 54210]]

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]
BILLING CODE 4164-01-P