[Federal Register Volume 81, Number 131 (Friday, July 8, 2016)]
[Notices]
[Pages 44628-44629]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16152]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Regional Public Workshop on the International Council for
Harmonization of Technical Requirements for Pharmaceuticals for Human
Use Q3D Implementation of Guideline for Elemental Impurities; Public
Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop entitled: Regional Public Workshop on ICH Q3D Implementation
of Guideline for Elemental Impurities. The purpose of the public
workshop is to elaborate key aspects of the ICH Guideline Q3D:
Guideline on Elemental Impurities in order facilitate a harmonized
interpretation and implementation by industry and regulators. It is not
intended to provide additional guidance beyond the scope of Q3D. The
meeting will take place on the FDA campus and also be broadcast on the
Web allowing participants to join in person or via the Web.
DATES: The public workshop will be held on August 22 and 23, from 9
a.m. to 5 p.m., EST. See the SUPPLEMENTARY INFORMATION section for
information on how to register.
ADDRESSES: The public workshop will be held at 10903 New Hampshire
Ave., Bldg. 31, Rm. 1503B/C, Silver Spring, MD 20993. The entrance for
the public workshop 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.
FOR FURTHER INFORMATION CONTACT: Amanda Roache, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1176, Silver
Spring, MD 20993, 301-796-4548, email: [email protected].
SUPPLEMENTARY INFORMATION: The ICH brings together regulatory
authorities and pharmaceutical industry to discuss scientific and
technical aspects of drug registration. The ICH's mission is to achieve
greater harmonization worldwide to ensure that safe, effective, and
high quality medicines are developed and registered in the most
resource-efficient manner. The ICH Q3D Guideline was developed by the
ICH to provide a global policy for limiting elemental impurities
qualitatively and quantitatively in drug products and ingredients.
Following finalization of this Guideline, an Implementation Working
Group was established to develop a comprehensive training program and
supporting documents sponsored by ICH to ensure the proper
interpretation and effective utilization
[[Page 44629]]
by industry and regulators alike to enable a harmonized and smooth
implementation of Q3D on a global basis.
The U.S. regional workshop is intended to clarify key aspects of
ICH Q3D: Guideline on Elemental Impurities by elaborating on those key
topics. It will include: (1) A discussion of how to apply Q3D concepts
to routes of administration, not addressed in Q3D, (2) justification
for elemental impurity levels higher than an established permissible
daily exposure (PDE) (3) application of Q3D concepts to determine safe
levels of elements not included in Q3D, (4) discussion of the rationale
for limits on large volume parenterals, (5) elaboration of the concepts
outlined in the Q3D Sections on Risk Assessment and Control of
Elemental Impurities and (6) options for converting between PDEs and
concentrations.
In addition, case studies may be presented to illustrate the
concepts described previously, and frequently asked questions will be
discussed. The presentation of the material will follow the modules
that are available on the ICH Web site, www.ich.org, and will include
time for questions and discussion. Breakout sessions will be provided
to discuss key topics and provide feedback to participants. Material
will be presented by members of the ICH Q3D Implementation Working
Group. The agenda for the workshop will be made available on the
internet at http://www.fda.gov/Drugs/NewsEvents/ucm498553.htm.
Registration: If you wish to attend this meeting, visit the
following Web site to register: https://www.eventbrite.com/e/regional-public-workshop-on-ich-q3d-implementation-of-guideline-for-elemental-impurities-tickets-25492458630. Please register by August 15, 2016. If
you are unable to attend the meeting in person, you can register to
view a live Webcast on the meeting. You will be asked to indicate in
your registration if you plan to attend in person or via the Webcast.
Your registration must also contain your complete contact information,
including name, title, affiliation, address, email address, and phone
number. 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. Onsite
registration on the day of the meeting will be based on space
availability. 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.
Dated: July 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16152 Filed 7-7-16; 8:45 am]
BILLING CODE 4164-01-P