United States Food and Drug Administration and Health Canada Joint Regional Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; Public Meeting; Request for Comments, 9001-9003 [2018-04256]
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Federal Register / Vol. 83, No. 42 / Friday, March 2, 2018 / Notices
that reflects the amount of food
customarily consumed and is expressed
in a common household measure that is
appropriate to the food. To comply with
this requirement, manufacturers must
determine and label their food products
with the appropriate label serving size
based on the amount of the product
customarily consumed.
In the Federal Register of May 27,
2016, we issued a final rule entitled
‘‘Food Labeling: Serving Sizes of Foods
That Can Reasonably Be Consumed at
One Eating Occasion; Dual-Column
Labeling; Updating, Modifying, and
Establishing Certain Reference Amounts
Customarily Consumed; Serving Size for
Breath Mints; and Technical
Amendments’’ (81 FR 34000). The final
rule amends our regulations in
§ 101.12(b) (21 CFR 101.12(b)) to update
or modify certain pre-existing RACCs,
and to establish RACCs for new product
categories.
In the Federal Register of January 5,
2017 (82 FR 1344), we announced the
availability of a draft guidance for
industry entitled ‘‘Reference Amounts
Customarily Consumed: List of Products
for Each Product Category; Draft
Guidance for Industry’’ and gave
interested parties an opportunity to
submit comments by March 6, 2017, for
us to consider before beginning work on
the final version of the guidance. We
received several comments on the draft
guidance and have modified the
content, where appropriate, for this final
guidance. Changes to the guidance
include the addition of flavored nut
butter spreads (e.g., cocoa, cookie, and
coffee flavored) as an example in the
‘‘Nut and seed butters, pastes, or
creams’’ product category. In the
Federal Register of November 2, 2016,
we published a Request for Information
and Comments requesting information
and comments on the appropriate
product category and RACC for flavored
nut butter spreads (e.g., cocoa, cookie,
and coffee flavored) (81 FR 76323).
Based upon the information and
comments received, and our own
assessment, we have determined that
flavored nut butter spreads (e.g., cocoa,
cookie, and coffee flavored) are
comparable to nut butters and belong in
the ‘‘Nut and seed butters, pastes, or
creams’’ product category with a RACC
of two tablespoons. In addition to this
and other clarifying substantive changes
that we made to the guidance, we made
editorial changes to improve clarity and
to help ensure consistency with
§ 101.12(b). The guidance announced in
this notice finalizes the draft guidance
dated January 2017.
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II. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/FoodGuidances or
https://www.regulations.gov. Use the
FDA website listed in the previous
sentence to find the most current
version of the guidance.
Dated: February 27, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–04283 Filed 3–1–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–1112]
United States Food and Drug
Administration and Health Canada
Joint Regional Consultation on the
International Council for
Harmonisation of Technical
Requirements for Pharmaceuticals for
Human Use; Public Meeting; Request
for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
announcing a regional public meeting
entitled ‘‘U.S. Food and Drug
Administration and Health Canada Joint
Regional Consultation on the
International Council for Harmonisation
of Technical Requirements for
Pharmaceuticals for Human Use (ICH).’’
The purpose of the public meeting is to
provide information and solicit public
input on the current activities of the
ICH, as well as the upcoming ICH
Assembly Meeting and the Expert
Working Group Meetings in Kobe,
Japan, scheduled for June 4 through 7,
2018. The topics to be addressed at the
public meeting are the current ICH
guideline topics under development
that will be discussed at the
forthcoming ICH Assembly Meeting in
Kobe.
SUMMARY:
The public meeting will be held
on Friday, April 6, 2018, from 10 a.m.
to 1 p.m. Submit either electronic or
written comments on this public
meeting by April 30, 2018. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public meeting will be
held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
DATES:
PO 00000
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Conference Center, Rm. 1503 (Great
Room), Silver Spring, MD 20993–0002.
The meeting will also be broadcast on
the web, allowing participants to join in
person OR via the web. For those who
will attend in person, the entrance for
the public meeting participants (nonFDA employees) is through Building 1
where routine security check
procedures will be performed. For
parking and security information, please
refer to https://www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm. For those who register
to attend the public meeting remotely
via the webcast, a link to access the
webcast will be emailed 1 week in
advance of the meeting.
You may submit comments as
follows. Please note that late, untimely,
filed comments will not be considered.
Electronic comments must be submitted
on or before April 30, 2018. The https://
www.regulations.gov electronic filing
system will accept comments until
midnight Eastern Time at the end of
April 30, 2018. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are postmarked or the
delivery service acceptance receipt is on
or before that date.
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 in the sections below
(see ‘‘Written/Paper Submissions’’ and
‘‘Instructions’’).
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Federal Register / Vol. 83, No. 42 / Friday, March 2, 2018 / Notices
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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–
2016–N–1112 for ‘‘U.S. Food and Drug
Administration and Health Canada Joint
Regional Consultation on the
International Council for Harmonisation
of Technical Requirements for
Pharmaceuticals for Human Use; Public
Meeting; Request for Comments.’’
Received comments, those filed in a
timely manner (see ADDRESSES), 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.
• 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.gpo.gov/
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fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
FOR FURTHER INFORMATION CONTACT:
Amanda Roache, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1176,
Silver Spring, MD 20993–0002, 301–
796–4548, Amanda.Roache@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The ICH, formerly known as the
International Conference on
Harmonisation, was established in 1990
as a joint regulatory/industry project to
improve, through harmonization, the
efficiency of the process for developing
and registering new medicinal products
in Europe, Japan, and the United States
without compromising the regulatory
requirements for safety and
effectiveness. One of the goals of
harmonization is to identify and then
reduce regional differences in technical
regulatory requirements for
pharmaceutical products while
preserving a consistently high standard
for drug efficacy, safety, and quality. In
2015, the ICH was reformed to establish
ICH as a true global initiative that
expands beyond the previous ICH
members. More involvement from
regulators around the world is expected,
as they join counterparts from Europe,
Japan, the United States, Canada, and
Switzerland as ICH observers and
regulatory members. Expanded
involvement is also anticipated from
global regulated pharmaceutical
industry parties, joining as ICH
observers and industry members. The
reforms build on a 25-year track record
of successful delivery of harmonized
guidelines for global pharmaceutical
development and their regulation.
ICH guidelines are developed
following a five-step process. In Step 1,
experts from the different ICH regions
work together to prepare a consensus
draft of the Step 1 Technical Document.
The Step 1 Technical Document is
submitted to the ICH Assembly to
request endorsement under Step 2a of
the process. Step 2b is a ‘‘Regulators
only’’ step in which the ICH regulatory
PO 00000
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members review the Step 2a Final
Technical Document and take any
actions, which might include revisions
that they deem necessary, to develop the
draft ‘‘Guideline.’’ Step 3 of the process
begins with the public consultation
process conducted by each of the ICH
regulatory members in their respective
regions, and this step concludes with
completion and acceptance of any
revisions that need to be made to the
Step 2b draft guideline in response to
public comments. Adoption of the new
guideline occurs in Step 4. Following
adoption, the harmonized guideline
moves to Step 5, the final step of the
process when it is implemented by each
of the regulatory members in their
respective regions. The ICH process has
achieved significant harmonization of
the technical requirements for the
approval of pharmaceuticals for human
use in the ICH regions since 1990. More
information on the current ICH process
and structure can be found at the
following website: https://www.ich.org/
home.html. (FDA has verified the
website addresses, as of the date this
document publishes in the Federal
Register, but websites are subject to
change over time.)
II. Topics for Discussion at the Public
Meeting
The topics for discussion at this
public meeting include the current
guidelines under development under
the ICH. These guidelines include the
following:
Topics Currently Under Regional
Public Consultation (Step 3 of ICH
Process):
• S11 Nonclinical Safety Testing in
Support of Development of Pediatric
Medicines
• Q12 Technical and Regulatory
Considerations for Pharmaceutical
Product Lifecycle Management
• E9(R1) Addendum: Statistical
Principles for Clinical Trials
Selected Topics Recently Finalized
(Step 4 of ICH Process):
• E17 General Principles on Planning/
Designing Multi-Regional Clinical
Trials
Electronic Standards and MedDRA
(Medical Dictionary for Regulatory
Activities):
• M2 Electronic Standards for the
Transfer of Regulatory Information
• M8 Electronic Common Technical
Document (eCTD)
• E2B Clinical Safety Data Management:
Data Elements for Transmission of
Individual Case Safety Reports
• M1 MedDRA Terminology
Additional Ongoing Topics:
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Federal Register / Vol. 83, No. 42 / Friday, March 2, 2018 / Notices
• E19 Optimization of Safety Data
Collection
• E8(R1) Revision on General
Considerations for Clinical Trials
• E11A Pediatric Extrapolation
• E14/S7B Discussion Group on
Clinical and Nonclinical Evaluation of
QT/QTc Interval Prolongation
• M9 Biopharmaceutics Classification
System-Based Biowaivers
• M10 Bioanalytical Method Validation
• S1(R1) Revision on Rodent
Carcinogenicity Studies for Human
Pharmaceuticals
• S5(R3) Revision on Detection of
Toxicity to Reproduction for Human
Pharmaceuticals
• Q3C(R7) Impurities: Guideline for
Residual Solvents
• Q3D(R1) Guideline on Elemental
Impurities
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III. Participating in the Public Meeting
Registration: Persons interested in
attending this public meeting must
register online by April 3, 2018. To
register for the public meeting, please
visit the following website: https://ich_
regional_consultation_
2018.eventbrite.com. Please provide
complete contact information for each
attendee, including name, title,
affiliation, address, email, and
telephone.
Registration is free and based on
space availability, with priority given to
early registrants. Persons interested in
attending this public meeting must
register by April 3, 2018, midnight
Eastern Time. Early registration is
recommended because seating is
limited; therefore, FDA may limit the
number of participants from each
organization. If time and space permit,
onsite registration on the day of the
public meeting will be provided
beginning at 9:30 a.m.
The agenda for the public meeting
will be made available on the internet
at https://www.fda.gov/Drugs/
NewsEvents/ucm592065.htm
approximately 2 weeks in advance of
the meeting.
If you need special accommodations
due to a disability, please contact
Amanda Roache (see FOR FURTHER
INFORMATION CONTACT) no later than
March 23, 2018.
Requests for Oral Presentations: If you
wish to make a presentation during the
public comment session, please contact
Amanda Roache (see FOR FURTHER
INFORMATION CONTACT) no later than
March 23, 2018. Individuals and
organizations with common interests are
urged to consolidate or coordinate their
presentations, and request time for a
joint presentation. All requests to make
presentations must be received by the
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Jkt 244001
close of registration on April 3, 2018. If
selected for presentation, any
presentation materials must be emailed
to Amanda Roache (see FOR FURTHER
INFORMATION CONTACT) no later than
April 3, 2018. No commercial or
promotional material will be permitted
to be presented or distributed at the
public meeting. Sign-up for making a
public comment will also be available
between 9 a.m. and 10 a.m. on the day
of the meeting.
Streaming Webcast of the Public
Meeting: This public meeting will also
be webcast. To register to attend via
webcast, please visit the following
website: https://ich_regional_
consultation_2018.eventbrite.com. If
you have never attended a Connect Pro
event before, test your connection at
https://collaboration.fda.gov/common/
help/en/support/meeting_test.htm. To
get a quick overview of the Connect Pro
program, visit https://www.adobe.com/
go/connectpro_overview. FDA has
verified the website addresses in this
document, as of the date this document
publishes in the Federal Register, but
websites are subject to change over time.
Dated: February 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–04256 Filed 3–1–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2004–N–0258]
Food Labeling: Serving Sizes of Foods
That Can Reasonably Be Consumed at
One Eating Occasion; Dual-Column
Labeling; Updating, Modifying, and
Establishing Certain Reference
Amounts Customarily Consumed;
Serving Size for Breath Mints; and
Technical Amendments—Small Entity
Compliance Guide; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notification of availability.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a
guidance for industry entitled ‘‘Food
Labeling: Serving Sizes of Foods That
Can Reasonably Be Consumed at One
Eating Occasion; Dual-Column Labeling;
Updating, Modifying, and Establishing
Certain Reference Amounts Customarily
Consumed; Serving Size for Breath
Mints; and Technical Amendments—
Small Entity Compliance Guide.’’ The
SUMMARY:
PO 00000
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9003
small entity compliance guide (SECG) is
intended to help small entities comply
with a final rule we issued in the
Federal Register of May 27, 2016,
entitled ‘‘Food Labeling: Serving Sizes
of Foods That Can Reasonably Be
Consumed at One Eating Occasion;
Dual-Column Labeling; Updating,
Modifying, and Establishing Certain
Reference Amounts Customarily
Consumed; Serving Size for Breath
Mints; and Technical Amendments.’’
The final rule is designed to ensure that
serving sizes are based on more recent
consumption data and that consumers
have serving size information on the
Nutrition Facts label that will assist
them in maintaining healthy dietary
practices.
DATES: The announcement of the
guidance is published in the Federal
Register on March 2, 2018.
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:
• 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
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]]>Agencies
[Federal Register Volume 83, Number 42 (Friday, March 2, 2018)]
[Notices]
[Pages 9001-9003]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04256]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-1112]
United States Food and Drug Administration and Health Canada
Joint Regional Consultation on the International Council for
Harmonisation of Technical Requirements for Pharmaceuticals for Human
Use; Public Meeting; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a regional public meeting entitled ``U.S. Food and Drug Administration
and Health Canada Joint Regional Consultation on the International
Council for Harmonisation of Technical Requirements for Pharmaceuticals
for Human Use (ICH).'' The purpose of the public meeting is to provide
information and solicit public input on the current activities of the
ICH, as well as the upcoming ICH Assembly Meeting and the Expert
Working Group Meetings in Kobe, Japan, scheduled for June 4 through 7,
2018. The topics to be addressed at the public meeting are the current
ICH guideline topics under development that will be discussed at the
forthcoming ICH Assembly Meeting in Kobe.
DATES: The public meeting will be held on Friday, April 6, 2018, from
10 a.m. to 1 p.m. Submit either electronic or written comments on this
public meeting by April 30, 2018. See the SUPPLEMENTARY INFORMATION
section for registration date and information.
ADDRESSES: The public meeting will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, Rm. 1503 (Great
Room), Silver Spring, MD 20993-0002. The meeting will also be broadcast
on the web, allowing participants to join in person OR via the web. For
those who will attend in person, the entrance for the public meeting
participants (non-FDA employees) is through Building 1 where routine
security check procedures will be performed. For parking and security
information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. For
those who register to attend the public meeting remotely via the
webcast, a link to access the webcast will be emailed 1 week in advance
of the meeting.
You may submit comments as follows. Please note that late,
untimely, filed comments will not be considered. Electronic comments
must be submitted on or before April 30, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 30, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
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 in the sections below (see ``Written/Paper Submissions'' and
``Instructions'').
[[Page 9002]]
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-2016-N-1112 for ``U.S. Food and Drug Administration and Health
Canada Joint Regional Consultation on the International Council for
Harmonisation of Technical Requirements for Pharmaceuticals for Human
Use; Public Meeting; Request for Comments.'' Received comments, those
filed in a timely manner (see ADDRESSES), 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.
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.gpo.gov/fdsys/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.
FOR FURTHER INFORMATION CONTACT: Amanda Roache, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1176, Silver Spring, MD 20993-0002, 301-
796-4548, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The ICH, formerly known as the International Conference on
Harmonisation, was established in 1990 as a joint regulatory/industry
project to improve, through harmonization, the efficiency of the
process for developing and registering new medicinal products in
Europe, Japan, and the United States without compromising the
regulatory requirements for safety and effectiveness. One of the goals
of harmonization is to identify and then reduce regional differences in
technical regulatory requirements for pharmaceutical products while
preserving a consistently high standard for drug efficacy, safety, and
quality. In 2015, the ICH was reformed to establish ICH as a true
global initiative that expands beyond the previous ICH members. More
involvement from regulators around the world is expected, as they join
counterparts from Europe, Japan, the United States, Canada, and
Switzerland as ICH observers and regulatory members. Expanded
involvement is also anticipated from global regulated pharmaceutical
industry parties, joining as ICH observers and industry members. The
reforms build on a 25-year track record of successful delivery of
harmonized guidelines for global pharmaceutical development and their
regulation.
ICH guidelines are developed following a five-step process. In Step
1, experts from the different ICH regions work together to prepare a
consensus draft of the Step 1 Technical Document. The Step 1 Technical
Document is submitted to the ICH Assembly to request endorsement under
Step 2a of the process. Step 2b is a ``Regulators only'' step in which
the ICH regulatory members review the Step 2a Final Technical Document
and take any actions, which might include revisions that they deem
necessary, to develop the draft ``Guideline.'' Step 3 of the process
begins with the public consultation process conducted by each of the
ICH regulatory members in their respective regions, and this step
concludes with completion and acceptance of any revisions that need to
be made to the Step 2b draft guideline in response to public comments.
Adoption of the new guideline occurs in Step 4. Following adoption, the
harmonized guideline moves to Step 5, the final step of the process
when it is implemented by each of the regulatory members in their
respective regions. The ICH process has achieved significant
harmonization of the technical requirements for the approval of
pharmaceuticals for human use in the ICH regions since 1990. More
information on the current ICH process and structure can be found at
the following website: https://www.ich.org/home.html. (FDA has verified
the website addresses, as of the date this document publishes in the
Federal Register, but websites are subject to change over time.)
II. Topics for Discussion at the Public Meeting
The topics for discussion at this public meeting include the
current guidelines under development under the ICH. These guidelines
include the following:
Topics Currently Under Regional Public Consultation (Step 3 of ICH
Process):
S11 Nonclinical Safety Testing in Support of Development of
Pediatric Medicines
Q12 Technical and Regulatory Considerations for Pharmaceutical
Product Lifecycle Management
E9(R1) Addendum: Statistical Principles for Clinical Trials
Selected Topics Recently Finalized (Step 4 of ICH Process):
E17 General Principles on Planning/Designing Multi-Regional
Clinical Trials
Electronic Standards and MedDRA (Medical Dictionary for Regulatory
Activities):
M2 Electronic Standards for the Transfer of Regulatory
Information
M8 Electronic Common Technical Document (eCTD)
E2B Clinical Safety Data Management: Data Elements for
Transmission of Individual Case Safety Reports
M1 MedDRA Terminology
Additional Ongoing Topics:
[[Page 9003]]
E19 Optimization of Safety Data Collection
E8(R1) Revision on General Considerations for Clinical Trials
E11A Pediatric Extrapolation
E14/S7B Discussion Group on Clinical and Nonclinical
Evaluation of QT/QTc Interval Prolongation
M9 Biopharmaceutics Classification System-Based Biowaivers
M10 Bioanalytical Method Validation
S1(R1) Revision on Rodent Carcinogenicity Studies for Human
Pharmaceuticals
S5(R3) Revision on Detection of Toxicity to Reproduction for
Human Pharmaceuticals
Q3C(R7) Impurities: Guideline for Residual Solvents
Q3D(R1) Guideline on Elemental Impurities
III. Participating in the Public Meeting
Registration: Persons interested in attending this public meeting
must register online by April 3, 2018. To register for the public
meeting, please visit the following website: https://ich_regional_consultation_2018.eventbrite.com. Please provide complete
contact information for each attendee, including name, title,
affiliation, address, email, and telephone.
Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
meeting must register by April 3, 2018, midnight Eastern Time. Early
registration is recommended because seating is limited; therefore, FDA
may limit the number of participants from each organization. If time
and space permit, onsite registration on the day of the public meeting
will be provided beginning at 9:30 a.m.
The agenda for the public meeting will be made available on the
internet at https://www.fda.gov/Drugs/NewsEvents/ucm592065.htm
approximately 2 weeks in advance of the meeting.
If you need special accommodations due to a disability, please
contact Amanda Roache (see FOR FURTHER INFORMATION CONTACT) no later
than March 23, 2018.
Requests for Oral Presentations: If you wish to make a presentation
during the public comment session, please contact Amanda Roache (see
FOR FURTHER INFORMATION CONTACT) no later than March 23, 2018.
Individuals and organizations with common interests are urged to
consolidate or coordinate their presentations, and request time for a
joint presentation. All requests to make presentations must be received
by the close of registration on April 3, 2018. If selected for
presentation, any presentation materials must be emailed to Amanda
Roache (see FOR FURTHER INFORMATION CONTACT) no later than April 3,
2018. No commercial or promotional material will be permitted to be
presented or distributed at the public meeting. Sign-up for making a
public comment will also be available between 9 a.m. and 10 a.m. on the
day of the meeting.
Streaming Webcast of the Public Meeting: This public meeting will
also be webcast. To register to attend via webcast, please visit the
following website: https://ich_regional_consultation_2018.eventbrite.com. If you have never
attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a
quick overview of the Connect Pro program, visit https://www.adobe.com/go/connectpro_overview. FDA has verified the website addresses in this
document, as of the date this document publishes in the Federal
Register, but websites are subject to change over time.
Dated: February 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-04256 Filed 3-1-18; 8:45 am]
BILLING CODE 4164-01-P
