83 FR 50110 - United States Food and Drug Administration and Health Canada Joint Public Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; Public Meeting and Webcast; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 193 (October 4, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 193 (October 4, 2018)
| Page Range | 50110-50112 | |
| FR Document | 2018-21594 |
[Federal Register Volume 83, Number 193 (Thursday, October 4, 2018)] [Notices] [Pages 50110-50112] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-21594] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-3636] United States Food and Drug Administration and Health Canada Joint Public Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; Public Meeting and Webcast; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting and webcast; 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 Public Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).'' The purpose of this public meeting is to provide information and solicit public input on the current activities of ICH as well as the upcoming ICH Assembly Meeting and the Expert Working Group Meetings in Charlotte, NC, scheduled for November 11 through 15, 2018. The topics to be discussed are the topics for discussion at the forthcoming ICH Assembly Meeting in Charlotte, NC. DATES: The public meeting will be held on October 17, 2018, from 9 a.m. to 12 p.m., Eastern Time. Submit either electronic or written comments on this [[Page 50111]] public meeting by October 31, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The public meeting will be held at the Sir Frederick G. Banting Research Centre, 251 Sir Frederick Banting Dr., Ottawa, ON K1Y 0M1, Canada. It will also be broadcast on the web, allowing participants to join in person or via the web. 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 October 31, 2018. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of October 31, 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 (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-2018-N-3636 for ``U.S. Food and Drug Administration and Health Canada Joint Public Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; Public Meeting and Webcast; 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 http://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.thefederalregister.org/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: 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 obligations of safety and effectiveness. 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 will join their counterparts from Europe, Japan, the United States, Canada, and Switzerland as ICH 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 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 [[Page 50112]] 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: http://www.ich.org. II. Participating in the Public Meeting Registration: Persons interested in attending this public meeting must register online by October 12, 2018. To register to attend the public meeting either in person or via webcast, please visit the following website: https://www.eventbrite.ca/e/health-canada-us-fda-ich-consultation-tickets-47713713000. 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 October 12, 2018, 11:59 p.m. Eastern Time. Early registration is recommended because seating is limited; therefore, the number of participants from each organization may be limited. The agenda for the public meeting will be made available on the internet at https://www.fda.gov/Drugs/NewsEvents/ucm612657.htm 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 October 12, 2018. 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 October 12, 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 October 12, 2018. If selected for presentation, any presentation materials must be emailed to William Lewallen (see FOR FURTHER INFORMATION CONTACT) no later than October 12, 2018. No commercial or promotional material will be permitted to be presented or distributed at the public 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://www.eventbrite.ca/e/health-canada-us-fda-ich-consultation-tickets-47713713000. 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: September 28, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-21594 Filed 10-3-18; 8:45 am] BILLING CODE 4164-01-P
![50110 Federal Register / Vol. 83, No. 193 / Thursday, October 4, 2018 / Notices
of comments to public dockets, see 80 FDA’s Decision Not to Issue Certain (OMB) under the Paperwork Reduction
FR 56469, September 18, 2015, or access Export Certificates for Devices.’’ Act of 1995 (44 U.S.C. 3501–3520). The
the information at: https://www.gpo.gov/ The Agency has received a request for collections of information in sections
fdsys/pkg/FR-2015-09-18/pdf/2015- a 30-day extension of the comment 801(e) and 802 of the Federal Food,
23389.pdf. period. The request conveyed concern Drug and Cosmetic Act (21 U.S.C. 381(e)
Docket: For access to the docket to that the current 60-day comment period and 382) have been approved under
read background documents or the does not allow sufficient time to OMB control number 0910–0498; the
electronic and written/paper comments develop a meaningful or thoughtful collections of information in 21 CFR
received, go to https:// response. part 807, subparts A through E, have
www.regulations.gov and insert the FDA has considered the request and been approved under OMB control
docket number, found in brackets in the is extending the comment period for the number 0910–0625; the collections of
heading of this document, into the notice of availability for 30 days, until information in 21 CFR part 820 have
‘‘Search’’ box and follow the prompts November 15, 2018. The Agency been approved under OMB control
and/or go to the Dockets Management believes that a 30-day extension allows number 0910–0073; and the collections
Staff, 5630 Fishers Lane, Rm. 1061, adequate time for interested persons to of information in the guidance ‘‘Center
Rockville, MD 20852. submit comments without significantly for Devices and Radiological Health
You may submit comments on any delaying guidance on these important Appeals Processes’’ have been approved
guidance at any time (see 21 CFR issues. under OMB control number 0910–0738.
10.115(g)(5)). II. Significance of Guidance Dated: September 28, 2018.
An electronic copy of the guidance This draft guidance is being issued Leslie Kux,
document is available for download consistent with FDA’s good guidance Associate Commissioner for Policy.
from the internet. See the practices regulation (21 CFR 10.115). [FR Doc. 2018–21597 Filed 10–3–18; 8:45 am]
SUPPLEMENTARY INFORMATION section for The draft guidance, when finalized, will BILLING CODE 4164–01–P
information on electronic access to the represent the current thinking of FDA
guidance. Submit written requests for a on the process to request a review of
single hard copy of the draft guidance FDA’s decision not to issue certain DEPARTMENT OF HEALTH AND
document entitled ‘‘Process to Request a export certificates for devices. It does HUMAN SERVICES
Review of FDA’s Decision Not to Issue not establish any rights for any person
Certain Export Certificates for Devices; and is not binding on FDA or the public. Food and Drug Administration
Draft Guidance for Industry and Food You can use an alternative approach if [Docket No. FDA–2018–N–3636]
and Drug Administration Staff’’ to the it satisfies the requirements of the
Office of the Center Director, Guidance applicable statutes and regulations. This United States Food and Drug
and Policy Development, Center for guidance is not subject to Executive Administration and Health Canada
Devices and Radiological Health, Food Order 12866. Joint Public Consultation on the
and Drug Administration, 10903 New International Council for
Hampshire Ave., Bldg. 66, Rm. 5431, III. Electronic Access
Harmonisation of Technical
Silver Spring, MD 20993–0002, or the Persons interested in obtaining a copy Requirements for Pharmaceuticals for
Office of Communication, Outreach, and of the draft guidance may do so by Human Use; Public Meeting and
Development, Center for Biologics downloading an electronic copy from Webcast; Request for Comments
Evaluation and Research, Food and the internet. A search capability for all
Drug Administration, 10903 New Center for Devices and Radiological AGENCY: Food and Drug Administration,
Hampshire Ave., Bldg. 71, Rm. 3128, Health guidance documents is available HHS.
Silver Spring, MD 20993–0002. Send at https://www.fda.gov/MedicalDevices/ ACTION:Notice of public meeting and
one self-addressed adhesive label to DeviceRegulationandGuidance/ webcast; request for comments.
assist that office in processing your GuidanceDocuments/default.htm. This
request. guidance document is also available at SUMMARY: The Food and Drug
https://www.fda.gov/BiologicsBlood Administration (FDA or Agency) is
FOR FURTHER INFORMATION CONTACT: announcing a regional public meeting
Vaccines/GuidanceCompliance
Joann Belt, Center for Devices and entitled ‘‘U.S. Food and Drug
RegulatoryInformation/default.htm or
Radiological Health, Food and Drug Administration and Health Canada Joint
https://www.regulations.gov. Persons
Administration, 10903 New Hampshire Public Consultation on International
unable to download an electronic copy
Ave., Bldg. 66, Rm. 3658, Silver Spring, Council for Harmonisation of Technical
of ‘‘Process to Request a Review of
MD 20993–0002, joann.belt@ Requirements for Pharmaceuticals for
FDA’s Decision Not to Issue Certain
fda.hhs.gov, 301–796–6836; or Stephen Human Use (ICH).’’ The purpose of this
Export Certificates for Devices; Draft
Ripley, Center for Biologics Evaluation public meeting is to provide information
Guidance for Industry and Food and
and Research, Food and Drug and solicit public input on the current
Drug Administration Staff’’ may send an
Administration, 10903 New Hampshire activities of ICH as well as the
email request to CDRH-Guidance@
Ave, Bldg. 71, Rm. 7301, Silver Spring, upcoming ICH Assembly Meeting and
fda.hhs.gov to receive an electronic
MD 20993, 240–402–7911. the Expert Working Group Meetings in
copy of the document. Please use the
SUPPLEMENTARY INFORMATION: document number 17044 to identify the Charlotte, NC, scheduled for November
guidance you are requesting. 11 through 15, 2018. The topics to be
daltland on DSKBBV9HB2PROD with NOTICES
I. Background discussed are the topics for discussion
In the Federal Register of August 17, IV. Paperwork Reduction Act of 1995 at the forthcoming ICH Assembly
2018, FDA published a notice of This draft guidance refers to Meeting in Charlotte, NC.
availability with a 60-day comment previously approved collections of DATES: The public meeting will be held
period to request comments on the draft information. These collections of on October 17, 2018, from 9 a.m. to 12
guidance for industry and FDA staff information are subject to review by the p.m., Eastern Time. Submit either
entitled ‘‘Process to Request a Review of Office of Management and Budget electronic or written comments on this
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![50112 Federal Register / Vol. 83, No. 193 / Thursday, October 4, 2018 / Notices
the technical requirements for the in the Federal Register, but websites are DEPARTMENT OF HEALTH AND
approval of pharmaceuticals for human subject to change over time. HUMAN SERVICES
use in the ICH regions since 1990. More Dated: September 28, 2018.
information on the current ICH process National Institutes of Health
Leslie Kux,
and structure can be found at the
following website: http://www.ich.org. Associate Commissioner for Policy. National Institute of Allergy and
[FR Doc. 2018–21594 Filed 10–3–18; 8:45 am] Infectious Diseases; Notice of Closed
II. Participating in the Public Meeting BILLING CODE 4164–01–P Meeting
Registration: Persons interested in
attending this public meeting must Pursuant to section 10(d) of the
register online by October 12, 2018. To DEPARTMENT OF HEALTH AND Federal Advisory Committee Act, as
register to attend the public meeting HUMAN SERVICES amended, notice is hereby given of a
either in person or via webcast, please meeting Allergy, Immunology, and
visit the following website: https:// National Institutes of Health Transplantation Research Committee.
www.eventbrite.ca/e/health-canada-us- The meeting will be closed to the
fda-ich-consultation-tickets- National Center for Advancing public in accordance with the
47713713000. Please provide complete Translational Sciences; Notice of provisions set forth in sections
contact information for each attendee, Closed Meeting 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
including name, title, affiliation, as amended. The grant applications and
address, email, and telephone. Pursuant to section 10(d) of the the discussions could disclose
Registration is free and based on Federal Advisory Committee Act, as confidential trade secrets or commercial
space availability, with priority given to amended, notice is hereby given of the property such as patentable material,
early registrants. Persons interested in following meeting. and personal information concerning
attending this public meeting must The meeting will be closed to the individuals associated with the grant
register by October 12, 2018, 11:59 p.m. public in accordance with the applications, the disclosure of which
Eastern Time. Early registration is provisions set forth in sections would constitute a clearly unwarranted
recommended because seating is 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., invasion of personal privacy.
limited; therefore, the number of as amended. The grant applications and Name of Committee: Allergy, Immunology,
participants from each organization may the discussions could disclose and Transplantation Research Committee
be limited. The agenda for the public confidential trade secrets or commercial AITC January 2019 Council.
meeting will be made available on the property such as patentable material, Date: October 23–24, 2018.
internet at https://www.fda.gov/Drugs/ and personal information concerning Time: 9:30 a.m. to 4:00 p.m.
NewsEvents/ucm612657.htm individuals associated with the grant Agenda: To review and evaluate grant
approximately 2 weeks in advance of applications, the disclosure of which applications.
the meeting. Place: National Institutes of Health, 5601
would constitute a clearly unwarranted
If you need special accommodations Fishers Lane, Rockville, MD 20892
invasion of personal privacy. (Telephone Conference Call).
due to a disability, please contact
Name of Committee: National Center for Contact Person: James T. Snyder, Ph.D.,
William Lewallen (see FOR FURTHER
Advancing Translational Sciences Special Scientific Review Officer Scientific Review
INFORMATION CONTACT) no later than Program, Division of Extramural Activities/
Emphasis Panel; CTSA Collaborative
October 12, 2018. Room 3G31B, National Institutes of Health,
Innovation Awards Review Meeting (U01).
Requests for Oral Presentations: If you NIAID, 5601 Fishers Lane MSC 9834,
Date: October 24, 2018.
wish to make a presentation during the Time: 2:00 p.m. to 5:00 p.m. Bethesda, MD 20892–9834, (240) 669–5060,
public comment session, please contact Agenda: To review and evaluate grant james.snyder@nih.gov.
William Lewallen (see FOR FURTHER applications. (Catalogue of Federal Domestic Assistance
INFORMATION CONTACT) no later than Place: National Institutes of Health, One Program Nos. 93.855, Allergy, Immunology,
October 12, 2018. Individuals and Democracy Plaza, Room 1068, 6701 and Transplantation Research; 93.856,
organizations with common interests are Democracy Boulevard, Bethesda, MD 20892 Microbiology and Infectious Diseases
urged to consolidate or coordinate their (Virtual Meeting). Research, National Institutes of Health, HHS)
presentations and request time for a Contact Person: M. Lourdes Ponce, Ph.D.,
Dated: September 28, 2018.
joint presentation. All requests to make Scientific Review Officer, Office of Scientific
Review, National Center for Advancing Natasha M. Copeland,
presentations must be received by the
close of registration on October 12, Translational Sciences (NCATS), National Program Analyst, Office of Federal Advisory
Institutes of Health, 6701 Democracy Blvd., Committee Policy.
2018. If selected for presentation, any
presentation materials must be emailed Democracy 1, Room 1073, Bethesda, MD [FR Doc. 2018–21572 Filed 10–3–18; 8:45 am]
20892, 301–435–0810, lourdes.ponce@ BILLING CODE 4140–01–P
to William Lewallen (see FOR FURTHER
nih.gov.
INFORMATION CONTACT) no later than
October 12, 2018. No commercial or (Catalogue of Federal Domestic Assistance
promotional material will be permitted Program Nos. 93.859, Pharmacology, DEPARTMENT OF HEALTH AND
Physiology, and Biological Chemistry HUMAN SERVICES
to be presented or distributed at the Research; 93.350, B—Cooperative
public meeting. Agreements; 93.859, Biomedical Research National Institutes of Health
Streaming Webcast of the Public and Research Training, National Institutes of
Meeting: This public meeting will also Health, HHS) National Institute of Diabetes and
daltland on DSKBBV9HB2PROD with NOTICES
be webcast. To register to attend via Digestive and Kidney Diseases; Notice
webcast, please visit the following Dated: September 28, 2018.
of Closed Meetings
website: https://www.eventbrite.ca/e/ David D. Clary,
health-canada-us-fda-ich-consultation- Program Analyst, Office of Federal Advisory Pursuant to section 10(d) of the
tickets-47713713000. FDA has verified Committee Policy. Federal Advisory Committee Act, as
the website addresses in this document, [FR Doc. 2018–21567 Filed 10–3–18; 8:45 am] amended, notice is hereby given of the
as of the date this document publishes BILLING CODE 4140–01–P following meetings.
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Document Created: 2018-10-04 02:02:22
Document Modified: 2018-10-04 02:02:22
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of public meeting and webcast; request for comments. | |
| Dates | The public meeting will be held on October 17, 2018, from 9 a.m. to 12 p.m., Eastern Time. Submit either electronic or written comments on this public meeting by October 31, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and 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] | |
| FR Citation | 83 FR 50110 |
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