[Federal Register Volume 90, Number 108 (Friday, June 6, 2025)]
[Notices]
[Pages 24146-24148]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-10359]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-3054]
M11 Technical Specification: Clinical Electronic Structured
Harmonised Protocol; International Council for Harmonisation; Draft
Technical Specification; and Template; 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 the revised draft technical specification entitled
``M11 Technical Specification: Clinical Electronic Structured
Harmonised Protocol (CeSHarP)'' and a supplemental document entitled
``M11 Template.'' The revised draft technical specification and
template were prepared under the auspices of the International Council
for Harmonisation of Technical Requirements for Pharmaceuticals for
Human Use (ICH). The revised draft technical specification recommends
the use of an open, nonproprietary standard to enable electronic
exchange of clinical protocol information. The template identifies
headers, common text, and a set of data fields and terminologies that
will be the basis for efficiencies in data exchange. These ICH
documents create an international standard for the content and exchange
of clinical trial protocol information facilitating review and
assessment by regulators, sponsors, ethical oversight bodies,
investigators, and other stakeholders. This revised draft technical
specification and updated template revise and replace the draft
versions of the same titles issued in December 2022.
DATES: Submit either electronic or written comments on the draft
guidance by July 7, 2025 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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.
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-2022-D-3054 for ``M11 Technical Specification: Clinical Electronic
Structured Harmonised Protocol (CeSHarP).'' 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
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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 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, 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: Veronica Pei, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 5338, Silver Spring, MD 20993-0002, 240-402-7091,
[email protected]; or James Myers, 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.
Regarding the ICH: Brooke Dal Santo, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6304, Silver Spring, MD 20993-0002, 301-348-1967,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of the revised draft technical
specification entitled ``M11 Technical Specification: Clinical
Electronic Structured Harmonised Protocol (CeSHarP)'' and a
supplemental document entitled ``M11 Template.'' The revised draft
technical specification and template were prepared under the auspices
of ICH. ICH seeks to achieve 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 enhance global drug development, improve manufacturing
standards, and increase the availability of medications. For example,
ICH guidelines have substantially reduced duplicative clinical studies,
prevented unnecessary animal studies, standardized the reporting of
important safety information, and standardized marketing application
submissions.
The six Founding Members of the ICH are the 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. ICH membership
continues to expand to include other regulatory authorities and
industry associations from around the world (refer to https://www.ich.org/).
ICH works by engaging global regulatory and industry experts in a
detailed, science-based, and 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 March 2025, the ICH Assembly endorsed the revised draft
technical specification entitled ``M11 Technical Specification:
Clinical Electronic Structured Harmonised Protocol (CeSHarP)'' and a
supplemental document entitled ``M11 Template'' and agreed that the
materials should be made available for public comment. The revised
draft technical specification and template are the products of the
Multidisciplinary Expert Working Group of the ICH. To support the
review and public comment on the completed technical specification, the
updated template is being provided as a reference document to aid in
the review and understanding of the technical specification, but FDA is
not seeking comment on the template. Comments about the technical
specification will be considered by FDA and the Multidisciplinary
Expert Working Group.
This technical specification revises the draft technical
specification entitled ``M11 Technical Specification: Clinical
Electronic Structured Harmonised Protocol (CeSHarP)'' and the
supplemental document entitled ``M11 Template'' that were issued on
December 22, 2022 (87 FR 78696), along with the draft guidance for
industry entitled ``M11 Clinical Electronic Structured Harmonised
Protocol (CeSHarP)'' (available at https://www.fda.gov/media/164112/download).
The technical specification recommends the use of an open,
nonproprietary standard to enable electronic exchange of clinical
protocol information. Revisions to the technical specification include
cardinality, definitions, and terminology alignment, reflecting both
prior public feedback and expert working group discussions. The
template's structure and content provide a framework for relevant
stakeholders to develop, review and use protocols that consistently and
unambiguously include a uniform table of contents, common section
headers and content, as well as common terminologies. Revisions to the
template include the table of contents, instructions, content, and
specifications for universal and optional text, reflection both prior
public feedback and expert working group discussions. The intent of the
draft guidance for industry and these supporting documents is to create
an international standard for the content and exchange of clinical
trial protocol information facilitating review and assessment by
regulators, sponsors, ethical oversight
[[Page 24148]]
bodies, investigators, and other stakeholders.
The revised draft technical specification and template have been
left in the original ICH format. The final technical specification and
template will be reformatted and edited to conform with FDA's good
guidance practices regulation (21 CFR 10.115) and style before
publication. The technical specification and template, when finalized,
will represent the current thinking of FDA on the topics they address.
They do not establish any rights for any person and are not binding on
FDA or the public. You can use an alternative approach if it satisfies
the requirements of the applicable statutes and regulations. As we
develop any final guidance on this topic, FDA will consider comments on
the applicability of Executive Order 14192, per OMB guidance M-25-20,
and in particular, on any costs or cost savings.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in 21 CFR part 312 pertaining to clinical trial design and protocols
have been approved under OMB control number 0910-0014.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance,
template, and technical specification at https://www.regulations.gov,
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, or
https://www.fda.gov/regulatory-information/search-fda-guidance-documents.
Dated: June 2, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-10359 Filed 6-5-25; 8:45 am]
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