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, 13659-13660 [2020-04754]

Download as PDF Federal Register / Vol. 85, No. 46 / Monday, March 9, 2020 / Notices ACTION: 27, 2020. 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 Vancouver. DATES: The public meeting will be held on Friday, April 3, 2020, from 10 a.m. to 1 p.m. Submit either electronic or written comments on this public meeting by Thursday, April 30, 2020. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The public meeting will be held at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, Rm. 1503 (the 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 May 20, 2019. The https:// www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time on Thursday, April 30, 2020. 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. 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 Vancouver, Canada, scheduled for May 23 through 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 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 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in 21 CFR parts 312 and 314 have been approved under OMB control numbers 0910–0014 and 0910– 0001, respectively. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs or https:// www.regulations.gov. Dated: March 2, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–04753 Filed 3–6–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–0256] 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. jbell on DSKJLSW7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:47 Mar 06, 2020 Jkt 250001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 13659 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– 2020–N–0256 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 E:\FR\FM\09MRN1.SGM 09MRN1 13660 Federal Register / Vol. 85, No. 46 / Monday, March 9, 2020 / Notices jbell on DSKJLSW7X2PROD with NOTICES 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. FOR FURTHER INFORMATION CONTACT: William Lewallen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6304, Silver Spring, MD 20993–0002, 301– 796–3810, William.Lewallen@ 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 it as a true global initiative and to expand 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 built on a 25-year track record VerDate Sep<11>2014 17:47 Mar 06, 2020 Jkt 250001 and have allowed ICH to continue its successful delivery of harmonized guidelines for global pharmaceutical development and their regulation. 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. 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. III. Participating in the Public Meeting Registration: Persons interested in attending this public meeting must register online by April 2, 2020. To register for the public meeting, please visit the following website: https://ich_ regional_consultation_ 2020.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 in person must register by April 2, 2020, 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, PO 00000 Frm 00039 Fmt 4703 Sfmt 9990 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://wcms-internet.fda.gov/drugs/ news-events-human-drugs/healthcanada-and-fda-joint-publicconsultation-international-councilharmonisation-technical-0 approximately 2 weeks in advance of the meeting. If you need special accommodations due to a disability, please contact William Lewallen (see FOR FURTHER INFORMATION CONTACT) no later than March 20, 2020. Persons attending FDA’s meetings are advised that FDA is not responsible for providing access to electrical outlets. Requests for Oral Presentations: If you wish to make a presentation during the public comment session, please contact William Lewallen (see FOR FURTHER INFORMATION CONTACT) no later than March 20, 2020. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations and request time for a joint presentation. If selected for presentation, any presentation materials must be emailed to William Lewallen (see FOR FURTHER INFORMATION CONTACT) no later than April 2, 2020. No commercial or promotional material will be permitted to be presented or distributed at the public meeting. Signup 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 through the following link: https://collaboration.fda.gov/ fdahealthcanada/. To register to attend via webcast, please visit the following website: https://ich_regional_ consultation_2020.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: March 2, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–04754 Filed 3–6–20; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\09MRN1.SGM 09MRN1

Agencies

[Federal Register Volume 85, Number 46 (Monday, March 9, 2020)]
[Notices]
[Pages 13659-13660]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04754]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0256]


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 Vancouver, Canada, scheduled for May 23 
through 27, 2020. 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 Vancouver.

DATES: The public meeting will be held on Friday, April 3, 2020, from 
10 a.m. to 1 p.m. Submit either electronic or written comments on this 
public meeting by Thursday, April 30, 2020. See the SUPPLEMENTARY 
INFORMATION section for registration date and information.

ADDRESSES: The public meeting will be held at FDA White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, Rm. 1503 (the 
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 May 20, 2019. The https://www.regulations.gov 
electronic filing system will accept comments until 11:59 p.m. Eastern 
Time on Thursday, April 30, 2020. 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 (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-2020-N-0256 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

[[Page 13660]]

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.

FOR FURTHER INFORMATION CONTACT: William Lewallen, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6304, Silver Spring, MD 20993-0002, 301-
796-3810, [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 it as a true global 
initiative and to expand 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 built on a 25-year track record and have allowed ICH to 
continue its successful delivery of harmonized guidelines for global 
pharmaceutical development and their regulation.

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. 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.

III. Participating in the Public Meeting

    Registration: Persons interested in attending this public meeting 
must register online by April 2, 2020. To register for the public 
meeting, please visit the following website: https://ich_regional_consultation_2020.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 in person must register by April 2, 2020, 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://wcms-internet.fda.gov/drugs/news-events-human-drugs/health-canada-and-fda-joint-public-consultation-international-council-harmonisation-technical-0 approximately 2 weeks in advance of the 
meeting.
    If you need special accommodations due to a disability, please 
contact William Lewallen (see FOR FURTHER INFORMATION CONTACT) no later 
than March 20, 2020.
    Persons attending FDA's meetings are advised that FDA is not 
responsible for providing access to electrical outlets.
    Requests for Oral Presentations: If you wish to make a presentation 
during the public comment session, please contact William Lewallen (see 
FOR FURTHER INFORMATION CONTACT) no later than March 20, 2020. 
Individuals and organizations with common interests are urged to 
consolidate or coordinate their presentations and request time for a 
joint presentation. If selected for presentation, any presentation 
materials must be emailed to William Lewallen (see FOR FURTHER 
INFORMATION CONTACT) no later than April 2, 2020. No commercial or 
promotional material will be permitted to be presented or distributed 
at the public meeting. Signup 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 through the following link: https://collaboration.fda.gov/fdahealthcanada/. To register to attend via 
webcast, please visit the following website: https://ich_regional_consultation_2020.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: March 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04754 Filed 3-6-20; 8:45 am]
BILLING CODE 4164-01-P

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