82 FR 13458 - United States Food and Drug Administration and Health Canada Joint Regional Consultation on 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 82, Issue 47 (March 13, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 47 (March 13, 2017)
| Page Range | 13458-13459 | |
| FR Document | 2017-04839 |
[Federal Register Volume 82, Number 47 (Monday, March 13, 2017)] [Notices] [Pages 13458-13459] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-04839] ----------------------------------------------------------------------- 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 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; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) is announcing a regional public meeting entitled ``U.S. Food and Drug Administration and Health Canada Joint Regional Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).'' The goal of this meeting is to provide information and receive comments on the current activities of ICH, as well as the upcoming ICH meetings in Montreal. The topics to be covered in the public meeting are the topics for discussion at the forthcoming ICH Assembly Meeting in Montreal. The purpose of this public meeting is also to solicit public input prior to the ICH Assembly meeting and the Expert Working Group meetings in Montreal, Canada, scheduled for May 28 through June 1, 2017. DATES: The public meeting will be held on April 24, 2017, from 11 a.m. to 2 p.m., Eastern Time. Submit either electronic or written comments on this public meeting by May 12, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before May 12, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of May 12, 2017. 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. See the SUPPLEMENTARY INFORMATION section for registration date and information. Registration to attend the meeting and requests for oral presentations must be received by April 19, 2017; see the SUPPLEMENTARY INFORMATION section for information on how to register for the meeting. ADDRESSES: The public meeting will be held at 10903 New Hampshire Ave., Bldg. 31, Rm. 1503 Section A, Silver Spring, MD 20993. It will also be broadcast on the Web allowing participants to join in person OR via the Web. 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 http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. You may submit comments 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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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 the U.S. Food and Drug Administration and Health Canada Joint Public Consultation on International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; Public Meeting. Received comments, those filed in a timely manner (see DATES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management 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 [[Page 13459]] 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 Division of Dockets Management. 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Amanda Roache, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Strategic Programs, 10903 New Hampshire Ave., Bldg. 51, Rm. 1176, Silver Spring MD, 20993, 301-796-4548, email: [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 make the ICH 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, USA, Canada, and Switzerland as ICH regulatory members. The reforms build on a 25-year track record of successful delivery of harmonized guidelines for global pharmaceutical development, and their regulation. In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for medical product development among regulatory Agencies. ICH was organized to provide an opportunity for harmonization initiatives to be developed with input from both regulatory and industry representatives. The ICH process has achieved significant harmonization of the technical requirements for the approval of pharmaceuticals for human use in the ICH regions over the past two decades. The current ICH process and structure can be found at the following Web site: http://www.ich.org. (FDA has verified the Web site addresses as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.) II. Webinar Attendance and Participation A. Registration If you wish to attend the meeting, please register at the following Web site: https://ich_regional_consultation.eventbrite.com. Registrations may be limited, so early registration is recommended. Registration is free and will be on a first-come, first-served basis. However, the number of participants from each organization may be limited based on space limitations. Registrants will receive confirmation once they have been accepted. If you need special accommodations because of a disability, please contact Amanda Roache (see FOR FURTHER INFORMATION CONTACT) at least 7 days before the meeting. B. Requests for Oral Presentations Interested persons may present data, information, or views orally or in writing on issues pending at the public meeting. Public oral presentations will be scheduled between approximately 1:30 p.m. and 2 p.m. Time allotted for oral presentations may be limited to 5 minutes. Those desiring to make oral presentations should notify Amanda Roache (see FOR FURTHER INFORMATION CONTACT) by April 19, 2017, and submit a brief statement of the general nature of the evidence or arguments they wish to present; the names and addresses, telephone number, fax, and email of proposed participants; and an indication of the approximate time requested to make their presentation. The agenda for the public Webinar will be made available on the Internet at http://www.fda.gov/Drugs/NewsEvents/ucm536015.htm. Dated: March 7, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-04839 Filed 3-10-17; 8:45 am] BILLING CODE 4164-01-P
![13458 Federal Register / Vol. 82, No. 47 / Monday, March 13, 2017 / Notices
ACL estimates the burden of this
collection of information as follows:
Responses Annual
Number of
Respondent/data collection activity per Hours per response burden
respondents respondent hours
Area Agency on Aging: Respondent selection process .............................. 250 1 4.0 ................................. 1,000
Service Recipients (i.e., Congregate and Home-delivered meal nutrition 4,000 1 .6667 ............................. 2,666.80
programs; Case Management, Homemaker, and Transportation Serv-
ices).
National Family Caregiver Support Program Clients ................................... 2,000 1 .6667 ............................. 1,333.40
Total ...................................................................................................... 6,250 1 .80 (weighted mean) ..... 5,000
Daniel Berger, untimely filed comments will not be anyone else’s Social Security number, or
Acting Administrator and Assistant Secretary considered. Electronic comments must confidential business information, such
for Aging. be submitted on or before May 12, 2017. as a manufacturing process. Please note
[FR Doc. 2017–04843 Filed 3–10–17; 8:45 am] The https://www.regulations.gov that if you include your name, contact
BILLING CODE 4154–01–P electronic filing system will accept information, or other information that
comments until midnight Eastern Time identifies you in the body of your
at the end of May 12, 2017. Comments comments, that information will be
DEPARTMENT OF HEALTH AND received by mail/hand delivery/courier posted on https://www.regulations.gov.
HUMAN SERVICES (for written/paper submissions) will be • If you want to submit a comment
considered timely if they are with confidential information that you
Food and Drug Administration postmarked or the delivery service do not wish to be made available to the
[Docket No. FDA–2016–N–1112] acceptance receipt is on or before that public, submit the comment as a
date. See the SUPPLEMENTARY written/paper submission and in the
United States Food and Drug INFORMATION section for registration date manner detailed (see ‘‘Written/Paper
Administration and Health Canada and information. Registration to attend Submissions’’ and ‘‘Instructions’’).
Joint Regional Consultation on the meeting and requests for oral
Written/Paper Submissions
International Council for presentations must be received by April
Harmonisation of Technical 19, 2017; see the SUPPLEMENTARY Submit written/paper submissions as
Requirements for Pharmaceuticals for INFORMATION section for information on follows:
Human Use; Public Meeting and how to register for the meeting. • Mail/Hand delivery/Courier (for
Webcast; Request for Comments ADDRESSES: The public meeting will be written/paper submissions): Division of
held at 10903 New Hampshire Ave., Dockets Management (HFA–305), Food
AGENCY: Food and Drug Administration, and Drug Administration, 5630 Fishers
Bldg. 31, Rm. 1503 Section A, Silver
HHS. Lane, Rm. 1061, Rockville, MD 20852.
Spring, MD 20993. It will also be
ACTION: Notice of public meeting; broadcast on the Web allowing • For written/paper comments
request for comments. participants to join in person OR via the submitted to the Division of Dockets
Web. Entrance for the public meeting Management, FDA will post your
SUMMARY: The Food and Drug comment, as well as any attachments,
Administration (FDA or the Agency) is participants (non-FDA employees) is
through Building 1 where routine except for information submitted,
announcing a regional public meeting marked and identified, as confidential,
entitled ‘‘U.S. Food and Drug security check procedures will be
performed. For parking and security if submitted as detailed in
Administration and Health Canada Joint ‘‘Instructions.’’
Regional Consultation on International information, please refer to http://www.
fda.gov/AboutFDA/WorkingatFDA/ Instructions: All submissions received
Council for Harmonisation of Technical must include the Docket No. FDA–
Requirements for Pharmaceuticals for BuildingsandFacilities/WhiteOak
CampusInformation/ucm241740.htm. 2016–N–1112 for the U.S. Food and
Human Use (ICH).’’ The goal of this Drug Administration and Health Canada
You may submit comments as
meeting is to provide information and Joint Public Consultation on
follows:
receive comments on the current International Council on Harmonisation
activities of ICH, as well as the Electronic Submissions of Technical Requirements for
upcoming ICH meetings in Montreal. Submit electronic comments in the Pharmaceuticals for Human Use; Public
The topics to be covered in the public following way: Meeting. Received comments, those
meeting are the topics for discussion at • Federal eRulemaking Portal: filed in a timely manner (see DATES),
the forthcoming ICH Assembly Meeting https://www.regulations.gov. Follow the will be placed in the docket and, except
in Montreal. The purpose of this public instructions for submitting comments. for those submitted as ‘‘Confidential
meeting is also to solicit public input Comments submitted electronically, Submissions,’’ publicly viewable at
prior to the ICH Assembly meeting and including attachments, to https:// https://www.regulations.gov or at the
the Expert Working Group meetings in www.regulations.gov will be posted to Division of Dockets Management
mstockstill on DSK3G9T082PROD with NOTICES
Montreal, Canada, scheduled for May 28 the docket unchanged. Because your between 9 a.m. and 4 p.m., Monday
through June 1, 2017. comment will be made public, you are through Friday.
DATES: The public meeting will be held solely responsible for ensuring that your • Confidential Submissions—To
on April 24, 2017, from 11 a.m. to 2 comment does not include any submit a comment with confidential
p.m., Eastern Time. Submit either confidential information that you or a information that you do not wish to be
electronic or written comments on this third party may not wish to be posted, made publicly available, submit your
public meeting by May 12, 2017. Late, such as medical information, your or comments only as a written/paper
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![Federal Register / Vol. 82, No. 47 / Monday, March 13, 2017 / Notices 13459
submission. You should submit two members. More involvement from 1:30 p.m. and 2 p.m. Time allotted for
copies total. One copy will include the regulators around the world is expected, oral presentations may be limited to 5
information you claim to be confidential as they will join their counterparts from minutes. Those desiring to make oral
with a heading or cover note that states Europe, Japan, USA, Canada, and presentations should notify Amanda
‘‘THIS DOCUMENT CONTAINS Switzerland as ICH regulatory members. Roache (see FOR FURTHER INFORMATION
CONFIDENTIAL INFORMATION.’’ The The reforms build on a 25-year track CONTACT) by April 19, 2017, and submit
Agency will review this copy, including record of successful delivery of a brief statement of the general nature of
the claimed confidential information, in harmonized guidelines for global the evidence or arguments they wish to
its consideration of comments. The pharmaceutical development, and their present; the names and addresses,
second copy, which will have the regulation. In recent years, many telephone number, fax, and email of
claimed confidential information important initiatives have been proposed participants; and an
redacted/blacked out, will be available undertaken by regulatory authorities indication of the approximate time
for public viewing and posted on and industry associations to promote requested to make their presentation.
https://www.regulations.gov. Submit international harmonization of The agenda for the public Webinar will
both copies to the Division of Dockets regulatory requirements. FDA has be made available on the Internet at
Management. If you do not wish your participated in many meetings designed http://www.fda.gov/Drugs/NewsEvents/
name and contact information to be to enhance harmonization and is ucm536015.htm.
made publicly available, you can committed to seeking scientifically Dated: March 7, 2017.
provide this information on the cover based harmonized technical procedures Leslie Kux,
sheet and not in the body of your for pharmaceutical development. One of
Associate Commissioner for Policy.
comments and you must identify this the goals of harmonization is to identify
[FR Doc. 2017–04839 Filed 3–10–17; 8:45 am]
information as ‘‘confidential.’’ Any and then reduce differences in technical
information marked as ‘‘confidential’’ requirements for medical product BILLING CODE 4164–01–P
will not be disclosed except in development among regulatory
accordance with 21 CFR 10.20 and other Agencies. ICH was organized to provide
DEPARTMENT OF HEALTH AND
applicable disclosure law. For more an opportunity for harmonization
HUMAN SERVICES
information about FDA’s posting of initiatives to be developed with input
comments to public dockets, see 80 FR from both regulatory and industry National Institutes of Health
56469, September 18, 2015, or access representatives. The ICH process has
the information at: https://www.gpo.gov/ achieved significant harmonization of Center for Scientific Review; Notice of
fdsys/pkg/FR-2015-09-18/pdf/2015- the technical requirements for the Closed Meetings
23389.pdf. approval of pharmaceuticals for human
Docket: For access to the docket to use in the ICH regions over the past two Pursuant to section 10(d) of the
read background documents or the decades. The current ICH process and Federal Advisory Committee Act, as
electronic and written/paper comments structure can be found at the following amended (5 U.S.C. App.), notice is
received, go to https:// Web site: http://www.ich.org. (FDA has hereby given of the following meetings.
www.regulations.gov and insert the verified the Web site addresses as of the The meetings will be closed to the
docket number, found in brackets in the date this document publishes in the public in accordance with the
heading of this document, into the Federal Register, but Web sites are provisions set forth in sections
‘‘Search’’ box and follow the prompts subject to change over time.) 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
and/or go to the Division of Dockets as amended. The grant applications and
Management, 5630 Fishers Lane, Rm. II. Webinar Attendance and the discussions could disclose
1061, Rockville, MD 20852. Participation confidential trade secrets or commercial
FOR FURTHER INFORMATION CONTACT: A. Registration property such as patentable material,
Amanda Roache, Food and Drug and personal information concerning
If you wish to attend the meeting, individuals associated with the grant
Administration, Center for Drug please register at the following Web site:
Evaluation and Research, Office of applications, the disclosure of which
https://ich_regional_consultation. would constitute a clearly unwarranted
Strategic Programs, 10903 New eventbrite.com. Registrations may be
Hampshire Ave., Bldg. 51, Rm. 1176, invasion of personal privacy.
limited, so early registration is
Silver Spring MD, 20993, 301–796– recommended. Registration is free and Name of Committee: Center for Scientific
4548, email: Review Special Emphasis Panel; AREA:
will be on a first-come, first-served
Amanda.Roache@fda.hhs.gov. Immunology.
basis. However, the number of Date: March 9, 2017.
SUPPLEMENTARY INFORMATION: participants from each organization may Time: 12:00 p.m. to 4:00 p.m.
be limited based on space limitations. Agenda: To review and evaluate grant
I. Background
Registrants will receive confirmation applications.
The ICH, formerly known as the once they have been accepted. If you Place: National Institutes of Health, 6701
International Conference on need special accommodations because Rockledge Drive, Bethesda, MD 20892
Harmonisation, was established in 1990 of a disability, please contact Amanda (Telephone Conference Call).
as a joint regulatory/industry project to Roache (see FOR FURTHER INFORMATION Contact Person: Alok Mulky, Ph.D.,
improve, through harmonization, the Scientific Review Officer, Center for
CONTACT) at least 7 days before the
efficiency of the process for developing Scientific Review (CSR), National Institutes
mstockstill on DSK3G9T082PROD with NOTICES
meeting. of Health (NIH), 6701 Rockledge Dr, Room
and registering new medicinal products 4203, Bethesda, MD 20817, (301) 435–3566,
in Europe, Japan, and the United States B. Requests for Oral Presentations
alok.mulky@nih.gov.
without compromising the regulatory Interested persons may present data, Name of Committee: Center for Scientific
obligations of safety and effectiveness. information, or views orally or in Review Special Emphasis Panel; Member
In 2015 the ICH was reformed to make writing on issues pending at the public Conflict: Neuropharmacology.
the ICH a true global initiative that meeting. Public oral presentations will Date: March 28, 2017.
expands beyond the previous ICH be scheduled between approximately Time: 2:00 p.m. to 5:30 p.m.
VerDate Sep<11>2014 17:49 Mar 10, 2017 Jkt 241001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\13MRN1.SGM 13MRN1](https://thefederalregister.org/doc/82_FR_13505/page/2.svg)
Document Created: 2018-02-01 14:57:51
Document Modified: 2018-02-01 14:57:51
| 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; request for comments. | |
| Dates | The public meeting will be held on April 24, 2017, from 11 a.m. to 2 p.m., Eastern Time. Submit either electronic or written comments on this public meeting by May 12, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before May 12, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of May 12, 2017. 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. See the SUPPLEMENTARY INFORMATION section for registration date and information. Registration to attend the meeting and requests for oral presentations must be received by April 19, 2017; see the SUPPLEMENTARY INFORMATION section for information on how to register for the meeting. | |
| Contact | Amanda Roache, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Strategic Programs, 10903 New Hampshire Ave., Bldg. 51, Rm. 1176, Silver Spring MD, 20993, 301-796-4548, email: [email protected] | |
| FR Citation | 82 FR 13458 |
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