M11 Clinical Electronic Structured Harmonised Protocol; International Council for Harmonisation; Draft Guidance for Industry; Draft Template; and Technical Specification; Availability, 78696-78698 [2022-27832]
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Federal Register / Vol. 87, No. 245 / Thursday, December 22, 2022 / Notices
on a limited basis for good cause shown.
If FDA grants a waiver, the applicant or
nonapplicant must comply with the
conditions for reporting specified by
FDA upon granting the waiver.
Description of Respondents:
Respondents to this collection of
information are applicants and
nonapplicants as defined in 21 CFR
514.3. Respondents include individuals
and the private sector (for-profit
businesses).
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FDA form
No.
21 CFR section
Medicated feed reports, 510.301(a) and
(b).
Submission of postmarketing safety reports under § 514.80(b)(1), (2)(i) and (ii),
(3), and (4)(iv)(A) and (C).
Voluntary reporting FDA Form 1932a for
the public.
514.80(b)(4) Periodic Drug Experience
Reports.
514.80(b)(5)(i) Special Drug Experience
Reports.
514.80(b(5)(ii) Advertisement and Promotional labeling.
514.80(b)(5)(iii) Distributor’s Statements ...
514.80(d)(2) ...............................................
Total ....................................................
1 There
Number of
responses per
respondent
Number of
respondents
Total annual
responses
Average burden
per response
Total hours
N/A
8
1
8
.25 (15 minutes) ..
2
1932
85
1249
98,639
1 ...........................
98,639
1932a
106
1
106
1 ...........................
106
2301
79
20
1,582
16 .........................
25,312
2301
78
215
16,790
2 ...........................
33,580
2301
38
192
7,282
2 ...........................
14,564
2301
N/A
22
1
2
1
36
1
2 ...........................
1 ...........................
72
1
....................
........................
........................
........................
..............................
172,276
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
Recordkeeping, 510.301 2 ....................................................
Recordkeeping, 21 U.S.C. 360b(1) and 514.80(e) 3 ...........
8
79
1
1,575.14
8
124,436
4
14
32
1,742,104
Total ..............................................................................
........................
........................
........................
........................
1,742,136
1 There
2 This
3 This
are no capital costs or operating and maintenance costs associated with this collection of information.
estimate includes all recordkeeping by licensed medicated feed manufacturers under § 510.301.
estimate includes all recordkeeping by applicants of approved NADAs, ANADAs, and conditional NADAs under § 514.80(e).
Upon review of the information
collection, we have adjusted our
estimated burden to reflect an overall
increase of 136,029.75 hours and
1,677,019 responses/records, annually.
Dated: December 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–27817 Filed 12–21–22; 8:45 am]
BILLING CODE 4164–01–P
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.
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,
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:01 Dec 21, 2022
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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,
E:\FR\FM\22DEN1.SGM
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Federal Register / Vol. 87, No. 245 / Thursday, December 22, 2022 / Notices
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’’).
lotter on DSK11XQN23PROD with NOTICES1
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
VerDate Sep<11>2014
18:01 Dec 21, 2022
Jkt 259001
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-201509-18/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
PO 00000
Frm 00067
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78697
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,
Yangveronica.Pei@fda.hhs.gov.
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,
Jill.Adleberg@fda.hhs.gov.
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
E:\FR\FM\22DEN1.SGM
22DEN1
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78698
Federal Register / Vol. 87, No. 245 / Thursday, December 22, 2022 / Notices
industry parties in detailed technical
harmonization work and the application
of a science-based approach to
harmonization through a consensusdriven 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
VerDate Sep<11>2014
18:01 Dec 21, 2022
Jkt 259001
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/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances.
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
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel Fellowships in
Digestive Diseases and Nutrition.
Date: February 16–17, 2023.
Time: 10:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute of Diabetes and Digestive
and Kidney Diseases, Democracy II, 6707
Democracy Blvd., Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Jian Yang, Ph.D., Scientific
Review Officer, Review Branch, DEA,
NIDDK, National Institutes of Health, Room
7011, 6707 Democracy Boulevard, Bethesda,
MD 20892–5452, (301) 594–7799, yangj@
extra.niddk.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: December 16, 2022.
David W Freeman,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–27823 Filed 12–21–22; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Notice To Announce the Updated
Significant Changes to the Revised
NIH Grants Policy Statement for Fiscal
Year 2023
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
Frm 00068
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ACTION:
Notice.
The National Institutes of
Health (NIH) announces publication of
the updated Significant Changes that
have already been made to the NIH
Grants Policy Statement (NIHGPS) in
fiscal year 2022 that will be reflected in
the GPS for fiscal year 2023. The
NIHGPS provides both up-to-date policy
guidance that serves as NIH standard
terms and conditions of award for all
NIH grants and cooperative agreements,
and extensive guidance to those who are
interested in pursuing NIH grants. This
update incorporates significant changes
for FY 2023, such as new and modified
SUMMARY:
National Institutes of Health
PO 00000
National Institutes of Health,
HHS.
E:\FR\FM\22DEN1.SGM
22DEN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]
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