[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