Document ID: FDA-2022-D-3054-0001
Agency: fda
Document Type: Notice
Title: M11 Clinical Electronic Structured Harmonised Protocol; International Council for Harmonisation; Draft Guidance for Industry; Draft Template; and Technical Specification; Availability
Posted Date: 2022-12-22T05:00Z

[Federal Register Volume 87, Number 245 (Thursday, December 22, 2022)]
[Notices]
[Pages 78696-78698]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27832]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-3054]

M11 Clinical Electronic Structured Harmonised Protocol; 
International Council for Harmonisation; Draft Guidance for Industry; 
Draft Template; and Technical Specification; 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the availability of a draft guidance for industry entitled ``M11 
Clinical Electronic Structured Harmonised Protocol (CeSHarP),'' and two 
supplemental documents entitled ``M11 Template,'' and ``M11 Technical 
Specification.'' The draft guidance, template, and technical 
specification were 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 The draft guidance provides recommendations for a 
harmonized clinical trial protocol including the organization of 
standardized content and formatting. The draft template identifies 
headers, common text, and a set of data fields and terminologies that 
will be the basis for efficiencies in data exchange. The technical 
specification recommends the use of an open, non-proprietary standard 
to enable electronic exchange of clinical protocol information. The 
intent of the draft guidance and supporting documents is to create an 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,

[[Page 78697]]

ethical oversight bodies, investigators, and other stakeholders.

DATES: Submit either electronic or written comments on the draft 
guidance by February 21, 2023 to ensure that the Agency considers your 
comment on this draft guidance, template, and technical specification 
before it begins work on the final versions.

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 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 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, 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].
    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, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``M11 Clinical Electronic Structured Harmonised Protocol 
(CeSHarP),'' and two supplemental documents entitled ``M11 Template,'' 
and ``M11 Technical Specification.'' The draft guidance, template, and 
technical specification were 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 https://www.ich.org/).
    ICH works by involving technical experts from both regulators and

[[Page 78698]]

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 September 2022, the ICH Assembly endorsed the draft guideline 
entitled ``M11 Clinical Electronic Structured Harmonised Protocol 
(CeSHarP)'' and two supplemental documents entitled ``M11 Template,'' 
and ``M11 Technical Specification'' and agreed that the materials 
should be made available for public comment. The draft guideline and 
supplemental documents are the product of the Multidisciplinary Expert 
Working Group of the ICH. Comments about these draft guidances will be 
considered by FDA and the Multidisciplinary Expert Working Group.
    The draft guidance provides recommendations for a harmonized 
clinical trial protocol including the organization of standardized 
content and formatting. The draft template identifies headers, common 
text, and a set of data fields and terminologies that will be the basis 
for efficiencies in data exchange. The technical specification 
recommends the use of an open, nonproprietary standard to enable 
electronic exchange of clinical protocol information. The intent of the 
draft guidance and 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 bodies, investigators, and other stakeholders.
    The draft guidance has been left in the original ICH format. The 
final guidance and supporting materials will be reformatted and edited 
to conform with FDA's good guidance practices regulation (21 CFR 
10.115) and style before publication. The draft guidance, template, and 
technical specification 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.

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 pertaining to clinical trial design 
and protocols have been approved under OMB control number 0910-0014. 
The collections of information pertaining to good clinical practice and 
for the implementation of improved and efficient approaches to clinical 
trial design have been approved under OMB control number 0910-0843.

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/regulatory-information/search-fda-guidance-documents, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances.

    Dated: December 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27832 Filed 12-21-22; 8:45 am]
BILLING CODE 4164-01-P