M12 Drug Interaction Studies; International Council for Harmonisation; Draft Guidance for Industry; Availability, 52801-52803 [2022-18521]
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Federal Register / Vol. 87, No. 166 / Monday, August 29, 2022 / Notices
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Ehcfosures
investigational drug. The draft guidance
is intended to decrease the risk of
adverse events, sometimes leading to
hospital admissions or reduced
treatment efficacy.
DATES: Submit either electronic or
written comments on the draft guidance
by September 28, 2022 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this draft guidance before it begins work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:
[FR Doc. 2022–18527 Filed 8–26–22; 8:45 am]
BILLING CODE 4164–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–D–1527]
M12 Drug Interaction Studies;
International Council for
Harmonisation; Draft Guidance for
Industry; Availability
AGENCY:
Electronic Submissions
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announcing the availability of a draft
guidance for industry entitled ‘‘M12
Drug Interaction Studies.’’ The draft
guidance was prepared under the
auspices of the International Council for
Harmonisation (ICH), formerly the
International Conference on
Harmonisation. The draft guidance
provides general recommendations on
how to evaluate the pharmacokinetic
drug interaction potential mediated via
enzyme and transporter for
investigational drugs. The draft
guidance harmonizes the regional
requirements on in vitro and clinical
evaluation of drug-drug interactions for
a more consistent approach in design,
conduct, and interpretation of enzyme
and transporter-mediated interaction
during the development of an
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:01 Aug 26, 2022
Jkt 256001
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
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
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–1527 for ‘‘M12 Drug Interaction
Studies.’’ 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
E:\FR\FM\29AUN1.SGM
29AUN1
EN29AU22.009</GPH>
Dated: August 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
52802
Federal Register / Vol. 87, No. 166 / Monday, August 29, 2022 / Notices
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 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.
khammond on DSKJM1Z7X2PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Kellie
Reynolds, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 2134, Silver Spring,
MD 20993–0002, 301–796–1594,
Kellie.Reynolds@fda.hhs.gov.
Regarding the ICH: Jill Adleberg,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
VerDate Sep<11>2014
17:01 Aug 26, 2022
Jkt 256001
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
‘‘M12 Drug Interaction Studies.’’ The
draft 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 resourceefficient 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 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. 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
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,
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
unless specific regulatory or statutory
requirements are cited.
In May 2022, the ICH Assembly
endorsed the draft guideline entitled
‘‘M12 Drug Interaction Studies’’ and
agreed that the guideline should be
made available for public comment. The
draft guideline is the product of the
Multidisciplinary Expert Working
Group of the ICH. Comments about this
draft will be considered by FDA and the
Multidisciplinary Expert Working
Group.
The draft guidance provides general
recommendations on how to evaluate
the pharmacokinetic drug interaction
potential mediated via enzyme and
transporter for investigational drugs.
The draft guideline harmonizes the
regional requirements on in vitro and
clinical evaluation of drug-drug
interactions for a more consistent
approach in design, conduct, and
interpretation of enzyme and
transporter-mediated interaction during
the development of an investigational
drug. It is intended to decrease the risk
of adverse events, sometimes leading to
hospital admissions or reduced
treatment efficacy.
This draft guidance has been left in
the original ICH format. The final
guidance 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, when finalized, will represent
the current thinking of FDA on ‘‘M12
Drug Interaction Studies.’’ 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
FDA tentatively concludes that this
draft guidance contains no collection of
information. Therefore, clearance by the
Office of Management and Budget under
the Paperwork Reduction Act of 1995 is
not required.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.regulations.gov, https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, or https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances, or https://www.fda.gov/
regulatory-information/search-fdaguidance-documents.
E:\FR\FM\29AUN1.SGM
29AUN1
Federal Register / Vol. 87, No. 166 / Monday, August 29, 2022 / Notices
business or professional affiliation of the
interested person.
Information is also available on the
Institute’s/Center’s home page: https://
orwh.od.nih.gov/, where an agenda and any
additional information for the meeting will
be posted when available.
Dated: August 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–18521 Filed 8–26–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Institutes of Health; Notice of Meeting
khammond on DSKJM1Z7X2PROD with NOTICES
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Advisory Committee on
Research on Women’s Health.
The meeting will be held as a virtual
meeting and open to the public.
Individuals who plan to view the virtual
meeting and need special assistance or
other reasonable accommodations to
view the meeting, should notify the
Contact Person listed below in advance
of the meeting. The meeting will be
videocast and can be accessed from the
NIH Videocasting and Podcasting
website (https://videocast.nih.gov/).
Name of Committee: Advisory Committee
on Research on Women’s Health.
Date: October 18, 2022.
Time: 9:30 a.m. to 4:00 p.m.
Agenda: ORWH Director’s Report;
Presentation from the Director of the National
Institute of Environmental Health Sciences
(NIEHS); Panel discussing the environmental
effects on the health of women; Presentation
on the content areas for the FY2024–2028
Strategic Plan on Research on the Health of
Women; e-Learning course demonstration;
and ORWH concept clearance.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Samia Noursi, Ph.D.,
Associate Director, Science Policy, Planning,
and Analysis, Office of Research on Women’s
Health, National Institutes of Health, 6707
Democracy Blvd., Room 402, Bethesda, MD
20892, 301–496–9472 samia.noursi@nih.gov.
Any member of the public interested in
presenting oral comments to the committee
may notify the Contact Person listed on this
notice at least 10 days in advance of the
meetings. Interested individuals and
representatives of organizations may submit
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allowed to present oral comments and if
accepted by the committee, presentations
may be limited to five minutes. Both printed
and electronic copies are requested for the
record. In addition, any interested person
may file written comments with the
committee by forwarding their statement to
the Contact Person listed on this notice. The
statement should include the name, address,
telephone number and when applicable, the
VerDate Sep<11>2014
17:01 Aug 26, 2022
Jkt 256001
(Catalogue of Federal Domestic Assistance
Program Nos. 93.14, Intramural Research
Training Award; 93.22, Clinical Research
Loan Repayment Program for Individuals
from Disadvantaged Backgrounds; 93.232,
Loan Repayment Program for Research
Generally; 93.39, Academic Research
Enhancement Award; 93.936, NIH Acquired
Immunodeficiency Syndrome Research Loan
Repayment Program; 93.187, Undergraduate
Scholarship Program for Individuals from
Disadvantaged Backgrounds, National
Institutes of Health, HHS)
Dated: August 23, 2022.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–18474 Filed 8–26–22; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; 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
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 on
Aging Initial Review Group; Career
Development For Early Career Investigators
Study Section.
Date: October 13–14, 2022.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute on Aging, Gateway
Building, 7201 Wisconsin Avenue, Bethesda,
MD 20892 (Virtual Meeting).
Contact Person: Carmen Moten, Ph.D.,
MPH, Scientific Review Officer, National
Institutes of Health, NCI Center to Reduce
Cancer Health Disparities, 6116 Executive
Boulevard, Suite 602, Bethesda, MD 20892,
301–496–8589, CMOTEN@MAIL.NIH.GOV.
PO 00000
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52803
Information is also available on the
Institute’s/Center’s home page:
www.nia.nih.gov/, where an agenda and any
additional information for the meeting will
be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: August 23, 2022,
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–18477 Filed 8–26–22; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Advancing
Translational Sciences; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings 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
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 Center for
Advancing Translational Sciences Special
Emphasis Panel; CTSA Training Grants
Review.
Date: September 13–14, 2022.
Time: 10 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Center for Advancing
Translational Sciences, National Institutes of
Health, 6701 Democracy Boulevard, Suite
1037, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Carol (Chang-Sook) Kim,
Ph.D., Scientific Review Administrator,
Office of Grants Management and Scientific
Review, National Center for Advancing
Translational Sciences, National Institutes of
Health, 6701 Democracy Boulevard, Suite
1037, Bethesda, MD 20892, (301) 402–1744,
carolko@mail.nih.gov.
Name of Committee: National Center for
Advancing Translational Sciences Special
Emphasis Panel; CTSA Resource Center
Review.
Date: October 14, 2022.
Time: 10 a.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Center for Advancing
Translational Sciences, National Institutes of
E:\FR\FM\29AUN1.SGM
29AUN1
]]>Agencies
[Federal Register Volume 87, Number 166 (Monday, August 29, 2022)]
[Notices]
[Pages 52801-52803]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18521]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-1527]
M12 Drug Interaction Studies; International Council for
Harmonisation; 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 ``M12 Drug
Interaction Studies.'' The draft guidance was prepared under the
auspices of the International Council for Harmonisation (ICH), formerly
the International Conference on Harmonisation. The draft guidance
provides general recommendations on how to evaluate the pharmacokinetic
drug interaction potential mediated via enzyme and transporter for
investigational drugs. The draft guidance harmonizes the regional
requirements on in vitro and clinical evaluation of drug-drug
interactions for a more consistent approach in design, conduct, and
interpretation of enzyme and transporter-mediated interaction during
the development of an investigational drug. The draft guidance is
intended to decrease the risk of adverse events, sometimes leading to
hospital admissions or reduced treatment efficacy.
DATES: Submit either electronic or written comments on the draft
guidance by September 28, 2022 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-1527 for ``M12 Drug Interaction Studies.'' 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
[[Page 52802]]
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 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: Kellie
Reynolds, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2134, Silver
Spring, MD 20993-0002, 301-796-1594, [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 ``M12 Drug Interaction Studies.'' The draft 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 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. 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
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 May 2022, the ICH Assembly endorsed the draft guideline entitled
``M12 Drug Interaction Studies'' and agreed that the guideline should
be made available for public comment. The draft guideline is the
product of the Multidisciplinary Expert Working Group of the ICH.
Comments about this draft will be considered by FDA and the
Multidisciplinary Expert Working Group.
The draft guidance provides general recommendations on how to
evaluate the pharmacokinetic drug interaction potential mediated via
enzyme and transporter for investigational drugs. The draft guideline
harmonizes the regional requirements on in vitro and clinical
evaluation of drug-drug interactions for a more consistent approach in
design, conduct, and interpretation of enzyme and transporter-mediated
interaction during the development of an investigational drug. It is
intended to decrease the risk of adverse events, sometimes leading to
hospital admissions or reduced treatment efficacy.
This draft guidance has been left in the original ICH format. The
final guidance 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, when finalized, will represent the
current thinking of FDA on ``M12 Drug Interaction Studies.'' 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
FDA tentatively concludes that this draft guidance contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at https://www.regulations.gov, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, or 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.
[[Page 52803]]
Dated: August 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-18521 Filed 8-26-22; 8:45 am]
BILLING CODE 4164-01-P
