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Notice2022-26433

E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials; International Council for Harmonisation; Guidance for Industry; Availability

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Published
December 6, 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 final guidance for industry entitled "E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-Approval Clinical Trials." The final guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation. The guidance revises the draft guidance for industry entitled "E19 Optimisation of Safety Data Collection" issued in June 2019. The final guidance provides recommendations regarding appropriate use of a selective approach to safety data collection in some late-stage pre- or post-marketing studies of drugs where the safety profile, with respect to commonly occurring adverse events, is well understood and documented. The final guidance is intended to advance important clinical research questions through the conduct of clinical investigations that collect relevant patient data, which will enable an adequate benefit-risk assessment of the drug for its intended use, while reducing the burden to patients from unnecessary tests that may yield limited additional information.

Full Text

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<title>Federal Register, Volume 87 Issue 233 (Tuesday, December 6, 2022)</title>
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[Federal Register Volume 87, Number 233 (Tuesday, December 6, 2022)]
[Notices]
[Pages 74637-74638]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-26433]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-1828]


E19 A Selective Approach to Safety Data Collection in Specific 
Late-Stage Pre-Approval or Post-Approval Clinical Trials; International 
Council for Harmonisation; 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 final guidance for industry entitled ``E19 A 
Selective Approach to Safety Data Collection in Specific Late-Stage 
Pre-approval or Post-Approval Clinical Trials.'' The final guidance was 
prepared under the auspices of the International Council for 
Harmonisation of Technical Requirements for Pharmaceuticals for Human 
Use (ICH), formerly the International Conference on Harmonisation. The 
guidance revises the draft guidance for industry entitled ``E19 
Optimisation of Safety Data Collection'' issued in June 2019. The final 
guidance provides recommendations regarding appropriate use of a 
selective approach to safety data collection in some late-stage pre- or 
post-marketing studies of drugs where the safety profile, with respect 
to commonly occurring adverse events, is well understood and 
documented. The final guidance is intended to advance important 
clinical research questions through the conduct of clinical 
investigations that collect relevant patient data, which will enable an 
adequate benefit-risk assessment of the drug for its intended use, 
while reducing the burden to patients from unnecessary tests that may 
yield limited additional information.

DATES: The announcement of the guidance is published in the Federal 
Register on December 6, 2022.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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-2019-D-1828 for ``E19 A Selective Approach to Safety Data 
Collection in Specific Late-Stage Pre-approval or Post-Approval 
Clinical Trials.'' 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 this 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, or the Office of 
Communication, Outreach and Development, Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration,

[[Page 74638]]

10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in 
processing your requests. The guidance may also be obtained by mail by 
calling CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: 
    Regarding the guidance: Mary Thanh Hai, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 2134, Silver Spring, MD 20993-0002, 301-796-2310, 
<a href="/cdn-cgi/l/email-protection#763b17040f58221e17181e3e171f36101217581e1e0558111900"><span class="__cf_email__" data-cfemail="1954786b60374d71787771517870597f7d783771716a377e766f">[email&#160;protected]</span></a>.
    Regarding the ICH: Jill Adleberg, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 6364, Silver Spring, MD 20993-0002, 301-796-5259, 
<a href="/cdn-cgi/l/email-protection#c08aa9acacee81a4aca5a2a5b2a780a6a4a1eea8a8b3eea7afb6"><span class="__cf_email__" data-cfemail="4b01222727650a2f272e292e392c0b2d2f2a65232338652c243d">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a final guidance for industry 
entitled ``E19 A Selective Approach to Safety Data Collection in 
Specific Late-Stage Pre-approval or Post-Approval Clinical Trials.'' 
The final guidance was prepared under the auspices of ICH. ICH has the 
mission of achieving greater regulatory harmonization worldwide to 
ensure that safe, effective, high-quality medicines are developed, 
registered, and maintained in the most resource-efficient manner.
    By harmonizing the regulatory requirements in regions around the 
world, ICH guidelines have substantially reduced duplicative clinical 
studies, prevented unnecessary animal studies, standardized the 
reporting of important safety information, standardized marketing 
application submissions, and made many other improvements in the 
quality of global drug development and manufacturing and the products 
available to patients.
    The six Founding Members of the ICH are FDA; the Pharmaceutical 
Research and Manufacturers of America; the European Commission; the 
European Federation of Pharmaceutical Industries Associations; the 
Japanese Ministry of Health, Labour, and Welfare; and the Japanese 
Pharmaceutical Manufacturers Association. The Standing Members of the 
ICH Association include Health Canada and Swissmedic. Additionally, the 
Membership of ICH has expanded to include other regulatory authorities 
and industry associations from around the world (refer to <a href="https://www.ich.org/">https://www.ich.org/</a>).
    ICH works by involving technical experts from both regulators and 
industry parties in detailed technical harmonization work and the 
application of a science-based approach to harmonization through a 
consensus-driven process that results in the development of ICH 
guidelines. The regulators around the world are committed to 
consistently adopting these consensus-based guidelines, realizing the 
benefits for patients and for industry.
    As a Founding Regulatory Member of ICH, FDA plays a major role in 
the development of each of the ICH guidelines, which FDA then adopts 
and issues as guidance for industry. FDA's guidance documents do not 
establish legally enforceable responsibilities. Instead, they describe 
the Agency's current thinking on a topic and should be viewed only as 
recommendations, unless specific regulatory or statutory requirements 
are cited.
    In April 2019, the ICH Assembly endorsed the draft guideline 
entitled ``E19 Optimisation of Safety Data Collection'' and agreed that 
the guideline should be made available for public comment. The 
guideline is the product of the Efficacy Expert Working Group of the 
ICH. In the Federal Register of June 27, 2019 (84 FR 30730), FDA 
published a notice announcing the availability of the draft guidance. 
The notice gave interested persons an opportunity to submit comments by 
September 25, 2019.
    After consideration of the comments received and revisions to the 
guideline, a final draft of the guideline was submitted to the ICH 
Assembly and endorsed by the regulatory agencies in September 2022.
    The final guidance provides recommendations regarding appropriate 
use of a selective approach to safety data collection in some late-
stage pre- or post-marketing studies of drugs where the safety profile, 
with respect to commonly occurring adverse events, is well understood 
and documented. The final guidance is intended to advance important 
clinical research questions through the conduct of clinical 
investigations that collect relevant patient data, which will enable an 
adequate benefit-risk assessment of the drug for its intended use, 
while reducing the burden to patients from unnecessary tests that may 
yield limited additional information.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). This guidance represents the 
current thinking of FDA on ``E19 A Selective Approach to Safety Data 
Collection in Specific Late-Stage Pre-approval or Post-Approval 
Clinical Trials.'' 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 have been approved under OMB control 
number 0910-0014. The collections of information in 21 CFR part 314 
have been approved under OMB control number 0910-0001. The collections 
of information in 21 CFR part 601 have been approved under OMB control 
number 0910-0338. FDA's guidance entitled ``E6(R2) Good Clinical 
Practice: Integrated Addendum to ICH E6(R1)'' (available at <a href="https://www.fda.gov/media/93884/download">https://www.fda.gov/media/93884/download</a>) have been approved under OMB control 
number 0910-0843.

III. Electronic Access

    Persons with access to the internet may obtain the final guidance 
at <a href="https://www.regulations.gov">https://www.regulations.gov</a>, <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/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>, or <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>.

    Dated: November 30, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-26433 Filed 12-5-22; 8:45 am]
BILLING CODE 4164-01-P


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