81 FR 64164 - Health Canada and United States Food and Drug Administration Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; Public Meeting and Webcast
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 181 (September 19, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 181 (September 19, 2016)
| Page Range | 64164-64166 | |
| FR Document | 2016-22471 |
[Federal Register Volume 81, Number 181 (Monday, September 19, 2016)] [Notices] [Pages 64164-64166] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-22471] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-1112] Health Canada and United States Food and Drug Administration Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; Public Meeting and Webcast 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 (which will also be Webcast) entitled ``Health Canada and U.S. Food and Drug Administration Joint Public Consultation on International Council for Harmonisation of Technical [[Page 64165]] 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 Osaka, Japan, in November 2016. The topics to be discussed are the topics for discussion at the forthcoming ICH Assembly Meeting in Osaka. The purpose of this public meeting is to solicit public input prior to the next ICH Assembly meeting and the Expert Working Group meetings in Osaka, Japan, scheduled for November 6 through November 11, 2015. DATES: The public meeting will be held on October 24, 2016, from 1 p.m. to 3 p.m., EST. Registration to attend the meeting and requests for oral presentations must be received by October 21, 2016; see the SUPPLEMENTARY INFORMATION section for information on how to register for the meeting. Interested persons may submit either electronic or written comments to the public docket (see ADDRESSES) by October 19, 2016. ADDRESSES: The meeting will be held at Sir Frederick G. Banting Research Centre, 251 Sir Frederick Banting Driveway, 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: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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 ``Health Canada and U.S. Food and Drug Administration Joint Public Consultation on International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; Public Meeting.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://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 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 http://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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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, the United States, 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 [[Page 64166]] 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://healthcanada-usfda_ich_consultation.eventbrite.ca. 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 Webinar. B. Requests for Oral Presentations Interested persons may present data, information, or views orally or in writing on issues pending at the public Webinar. Public oral presentations will be scheduled between approximately 2:30 p.m. and 3 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 October 19, 2016, 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/ucm516166.htm. Dated: September 14, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-22471 Filed 9-16-16; 8:45 am] BILLING CODE 4164-01-P
![64164 Federal Register / Vol. 81, No. 181 / Monday, September 19, 2016 / Notices
ethylone has been sold as the street drug chemical structural class with an WHO’s consideration in deciding
‘‘Molly’’ and encountered as a indazole core. In vitro studies show that whether to recommend international
replacement for methylone. As a it binds to the cannabinoid CB1 control/decontrol of any of these drugs.
positional isomer of the controlled drug receptors and displays agonist Such control could limit, among other
butylone, ethylone is considered a properties in functional assays, things, the manufacture and distribution
Schedule I controlled substance under suggesting that it would share in vivo (import/export) of these drugs and could
the CSA. effects with delta-9-THC and various impose certain recordkeeping
Ethylphenidate (EPH) is structurally synthetic cannabinoids. There are no requirements on them.
related to methylphenidate. commercial or medical uses for 5F- Although FDA is, through this notice,
Methylphenidate is controlled in APINACA. Synthetic cannabinoids are requesting comments from interested
Schedule IV of the CSA, and an active marketed under the guise of ‘‘herbal persons which will be considered by
ingredient in drug products approved incense,’’ and promoted by drug HHS when it prepares an evaluation of
for medical use and marketed in the traffickers as legal alternatives to these drugs, HHS will not now make
United States. Ethylphenidate is not marijuana. SF-APINACA is not a any recommendations to WHO
approved for medical use in the United controlled substance under the CSA, but regarding whether any of these drugs
States. Ethylphenidate is structurally may be treated as a ‘‘controlled should be subjected to international
related to methylphenidate are being substance analogue’’ under the CSA controls. Instead, HHS will defer such
marketed as novel psychoactive pursuant to 21 U.S.C. 802(32)(A) and consideration until WHO has made
substances with psychoactive effects 813. official recommendations to the
similar to methylphenidate, therefore JWH-073 is an indole-based synthetic Commission on Narcotic Drugs, which
posing similar health risks to the users. cannabinoid agonist without the are expected to be made in early 2017.
Ethylphenidate is a controlled substance classical cannabinoid chemical Any HHS position regarding
in several European countries, and is structure. Pharmacology studies have international control of these drugs will
not a controlled substance in the United been conducted on this substance. be preceded by another Federal Register
States under the CSA. Behavioral pharmacology studies show notice soliciting public comments, as
Methiopropamine (MPA) is a that JWH-073 has delta-9-THC-like required by section 201(d)(2)(B) of the
structural analogue of the Schedule II activity in animals. Synthetic CSA.
controlled substance methamphetamine. cannabinoids are marketed under the
Pharmacologically, it functions as a V. Electronic Access
guise of ‘‘herbal incense,’’ and promoted
norepinephrine-dopamine reuptake by drug traffickers as legal alternatives Persons with access to the Internet
inhibitor and, secondarily, as a to marijuana. On March 1, 2011, JWH- may obtain the document at either
serotonin reuptake inhibitor. MPA is a 073 was temporarily controlled in http://www.fda.gov/Drugs/Guidance
thiophene based analog of Schedule I and on July 9, 2012, JWH- ComplianceRegulatoryInformation/
methamphetamine. It has stimulant 073 was permanently controlled as a Guidances/default.htm or http://
properties as an inhibitor of dopamine, Schedule I substance under the CSA. www.regulations.gov.
norepinephrine transporters in the XLR-11 (5-Fluoro-UR-144, 5F-UR-144) Dated: September 14, 2016.
central nervous system. MPA was is an indole-based synthetic Leslie Kux,
critically reviewed by the WHO at its cannabinoid and acts as an agonist at
Associate Commissioner for Policy.
36th meeting of the Expert Committee cannabinoid CB1 receptors. Animal
[FR Doc. 2016–22472 Filed 9–16–16; 8:45 am]
on Drug Dependence in June 2014. It is studies indicate that it mimics
BILLING CODE 4164–01–P
not approved for medical use or functionally (biologically) the effects of
controlled in the United States under the structurally unrelated delta-9-THC, a
the CSA, but is a controlled substance Schedule I substance, and the main
DEPARTMENT OF HEALTH AND
in the United Kingdom. active ingredient of marijuana and
MDMB-CHMICA is an indole-based HUMAN SERVICES
numerous other Schedule I synthetic
synthetic cannabinoid that is a potent cannabinoids. Synthetic cannabinoids Food and Drug Administration
full agonist at CB1 receptors and mimics are marketed under the guise of ‘‘herbal
functionally (biologically) the effects of incense,’’ and promoted by drug [Docket No. FDA–2016–N–1112]
the structurally unrelated delta-9- traffickers as legal alternatives to
tetrahydrocannabinol (THC), a Schedule Health Canada and United States Food
marijuana. On May 16, 2013, XLR-11
I substance, and the main active and Drug Administration Joint Public
was temporarily placed under Schedule
ingredient of marijuana. Synthetic Consultation on International Council
I and on May 11, 2016, XLR11 was
cannabinoids are marketed under the for Harmonisation of Technical
permanently controlled as a Schedule I
guise of ‘‘herbal incense,’’ and promoted Requirements for Pharmaceuticals for
substance under the CSA.
by drug traffickers as legal alternatives Human Use; Public Meeting and
to marijuana. MDMB-CHMICA use is IV. Opportunity To Submit Domestic Webcast
associated with serious adverse events Information
AGENCY: Food and Drug Administration,
including death in several European As required by section 201(d)(2)(A) of HHS.
countries. There are no commercial or the CSA, FDA, on behalf of the ACTION:Notice of public meeting and
approved medical uses for MDMB- Department of Health and Human Webcast; request for comments.
CHMICA. MDMB-CHMICA is not Services (HHS), invites interested
controlled under the CSA, but may be persons to submit comments regarding SUMMARY: The Food and Drug
mstockstill on DSK3G9T082PROD with NOTICES
treated as a ‘‘controlled substance the 12 named drugs. Any comments Administration (FDA or Agency) is
analogue’’ under the CSA pursuant to 21 received will be considered by HHS announcing a regional public meeting
U.S.C 802(32)(A) and 813, and is a when it prepares a scientific and (which will also be Webcast) entitled
controlled substance in the State of medical evaluation of these drugs. HHS ‘‘Health Canada and U.S. Food and Drug
Louisiana. will forward a scientific and medical Administration Joint Public
5F-APINACA (5F-AKB48) is a evaluation of these drugs to WHO, Consultation on International Council
synthetic cannabinoid belonging to a through the Secretary of State, for for Harmonisation of Technical
VerDate Sep<11>2014 21:47 Sep 16, 2016 Jkt 238001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\19SEN1.SGM 19SEN1](https://thefederalregister.org/doc/81_FR_64345/page/1.svg)
![64166 Federal Register / Vol. 81, No. 181 / Monday, September 19, 2016 / Notices
the technical requirements for the DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper
approval of pharmaceuticals for human HUMAN SERVICES Submissions’’ and ‘‘Instructions’’).
use in the ICH regions over the past two Written/Paper Submissions
decades. The current ICH process and Food and Drug Administration
structure can be found at the following Submit written/paper submissions as
[Docket No. FDA–2016–N–2683] follows:
Web site: http://www.ich.org. (FDA has
• Mail/Hand delivery/Courier (for
verified the Web site addresses as of the Agency Information Collection written/paper submissions): Division of
date this document publishes in the Activities; Proposed Collection; Dockets Management (HFA–305), Food
Federal Register, but Web sites are Comment Request; Data To Support and Drug Administration, 5630 Fishers
subject to change over time.) Social and Behavioral Research as Lane, rm. 1061, Rockville, MD 20852.
II. Webinar Attendance and
Used by the Food and Drug • For written/paper comments
Administration submitted to the Division of Dockets
Participation
AGENCY: Food and Drug Administration, Management, FDA will post your
A. Registration HHS. comment, as well as any attachments,
except for information submitted,
If you wish to attend the meeting, ACTION: Notice. marked and identified, as confidential,
please register at the following Web site: if submitted as detailed in
SUMMARY: The Food and Drug
https://healthcanada-usfda_ich_ ‘‘Instructions.’’
Administration (FDA) is announcing an
consultation.eventbrite.ca. Registrations Instructions: All submissions received
opportunity for public comment on the
may be limited, so early registration is must include the Docket No. FDA–
proposed collection of certain
recommended. Registration is free and 2016–N–2683 for ‘‘Data To Support
information by the Agency. Under the
will be on a first-come, first-served Social and Behavioral Research as Used
Paperwork Reduction Act of 1995 (the
basis. However, the number of by the Food and Drug Administration.’’
PRA), Federal Agencies are required to
participants from each organization may Received comments will be placed in
publish notice in the Federal Register
be limited based on space limitations. the docket and, except for those
concerning each proposed collection of
Registrants will receive confirmation submitted as ‘‘Confidential
information and to allow 60 days for Submissions,’’ publicly viewable at
once they have been accepted. If you public comment in response to the
need special accommodations because http://www.regulations.gov or at the
notice. This notice solicits comments on Division of Dockets Management
of a disability, please contact Amanda a generic clearance to collect between 9 a.m. and 4 p.m., Monday
Roache (see FOR FURTHER INFORMATION information to support social and through Friday.
CONTACT) at least 7 days before the behavioral research used by FDA about • Confidential Submissions—To
Webinar. drug products. submit a comment with confidential
DATES: Submit either electronic or information that you do not wish to be
B. Requests for Oral Presentations
written comments on the collection of made publicly available, submit your
Interested persons may present data, information by November 18, 2016. comments only as a written/paper
information, or views orally or in ADDRESSES: You may submit comments submission. You should submit two
writing on issues pending at the public as follows: copies total. One copy will include the
Webinar. Public oral presentations will information you claim to be confidential
Electronic Submissions with a heading or cover note that states
be scheduled between approximately
2:30 p.m. and 3 p.m. Time allotted for Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
oral presentations may be limited to 5 following way: CONFIDENTIAL INFORMATION.’’ The
minutes. Those desiring to make oral • Federal eRulemaking Portal: http:// Agency will review this copy, including
presentations should notify Amanda www.regulations.gov. Follow the the claimed confidential information, in
Roache (see FOR FURTHER INFORMATION instructions for submitting comments. its consideration of comments. The
CONTACT) by October 19, 2016, and
Comments submitted electronically, second copy, which will have the
including attachments, to http:// claimed confidential information
submit a brief statement of the general
www.regulations.gov will be posted to redacted/blacked out, will be available
nature of the evidence or arguments
the docket unchanged. Because your for public viewing and posted on http://
they wish to present; the names and
comment will be made public, you are www.regulations.gov. Submit both
addresses, telephone number, FAX, and solely responsible for ensuring that your copies to the Division of Dockets
email of proposed participants; and an comment does not include any Management. If you do not wish your
indication of the approximate time confidential information that you or a name and contact information to be
requested to make their presentation. third party may not wish to be posted, made publicly available, you can
The agenda for the public Webinar will such as medical information, your or provide this information on the cover
be made available on the Internet at anyone else’s Social Security number, or sheet and not in the body of your
http://www.fda.gov/Drugs/NewsEvents/ confidential business information, such comments and you must identify this
ucm516166.htm. as a manufacturing process. Please note information as ‘‘confidential.’’ Any
Dated: September 14, 2016. that if you include your name, contact information marked as ‘‘confidential’’
Leslie Kux,
information, or other information that will not be disclosed except in
identifies you in the body of your accordance with 21 CFR 10.20 and other
mstockstill on DSK3G9T082PROD with NOTICES
Associate Commissioner for Policy. comments, that information will be applicable disclosure law. For more
[FR Doc. 2016–22471 Filed 9–16–16; 8:45 am] posted on http://www.regulations.gov. information about FDA’s posting of
BILLING CODE 4164–01–P • If you want to submit a comment comments to public dockets, see 80 FR
with confidential information that you 56469, September 18, 2015, or access
do not wish to be made available to the the information at: http://www.fda.gov/
public, submit the comment as a regulatoryinformation/dockets/
written/paper submission and in the default.htm.
VerDate Sep<11>2014 21:47 Sep 16, 2016 Jkt 238001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\19SEN1.SGM 19SEN1](https://thefederalregister.org/doc/81_FR_64345/page/3.svg)
Document Created: 2016-09-17 02:30:49
Document Modified: 2016-09-17 02:30:49
| 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 24, 2016, from 1 p.m. to 3 p.m., EST. Registration to attend the meeting and requests for oral presentations must be received by October 21, 2016; see the SUPPLEMENTARY INFORMATION section for information on how to register for the meeting. Interested persons may submit either electronic or | |
| 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 | 81 FR 64164 |
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