Pathways to Global Unity; Public Workshop, 11761 [2018-05389]
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Federal Register / Vol. 83, No. 52 / Friday, March 16, 2018 / Notices
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Yinghua Wang
(see FOR FURTHER INFORMATION CONTACT)
at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at
https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm111462.htm for
procedures on public conduct during
advisory committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: March 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0757]
Pathways to Global Unity; Public
Workshop
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA), in collaboration
with the Association of Food and Drug
Officials (AFDO), is announcing the
following public workshop entitled
‘‘Pathways to Global Unity.’’ This 21⁄2day public workshop is intended to
provide information about FDA drug
and device regulation to the regulated
industries.
SUMMARY:
The public workshop will be
held on June 11–12, 2018, from 8 a.m.
to 5:30 p.m., and on June 13, 2018, from
8 a.m. to 12 p.m.
ADDRESSES: The public workshop will
be held at the Doubletree by Hilton
Hotel Burlington Vermont, 870
Williston Rd., Burlington, VT 05403,
802–865–6626. For directions to the
hotel and information on lodging, visit
https://burlington.afdo.org/hotel.html.
Attendees are responsible for their own
accommodations.
FOR FURTHER INFORMATION CONTACT:
Krystal Reed, Association of Food and
Drug Officials, 155 West Market St., 3rd
Floor, York, PA 17401, 717–757–2888,
Fax: 717–650–3650, email: kreed@
afdo.org.
daltland on DSKBBV9HB2PROD with NOTICES
DATES:
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
21:54 Mar 15, 2018
Jkt 244001
FDA has made education of the drug
and device manufacturing community a
high priority to help ensure the quality
of FDA-regulated drugs and devices.
The workshop helps to achieve
objectives set forth in section 406 of the
Food and Drug Administration
Modernization Act of 1997 (21 U.S.C.
393), which includes working closely
with stakeholders and maximizing the
availability and clarity of information to
stakeholders and the public. The
workshop also is consistent with the
Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104–121),
as outreach activities by government
agencies to small businesses.
II. Topics for Discussion at the Public
Workshop
[FR Doc. 2018–05386 Filed 3–15–18; 8:45 am]
AGENCY:
I. Background
The public workshop helps fulfill the
Department of Health and Human
Services and FDA’s mission to protect
the public health. The workshop will
provide FDA-regulated drug and device
entities with information on a number
of topics concerning FDA requirements
related to the production and marketing
of drugs and/or devices. The public
workshop’s agenda is available at https://
www.afdo.org/conference. Topics for
discussion include the following:
• FDA Associate Commissioner for
Regulatory Affairs Update
• Health Canada: Single Audit Program
• Enforcement Trends in Drug, Devices,
and Compounding Pharmacy
Inspections
• FDA Compliance Questions Panel
• International Compliance—Industry
Perspective
• Puerto Rico Emergency Response
Update
• Artificial Intelligence
• Supply Chain Control
• Dermal Abyss: Tattoos as Medical
Condition Monitors
• Design Controls for Combination
Products
• Benefit Risk—Using Benefit Risk in
Making Post-Market Decisions
III. Participating in the Public
Workshop
Frm 00093
Fmt 4703
Sfmt 4703
Category
Cost of
registration
AFDO Members ....................
AFDO Non-Members ............
Additional Fee for Registration Postmarked After May
1, 2018 ..............................
$550
650
100
To register online, please visit https://
www.afdo.org/conference (FDA has
verified the website address, but is not
responsible for subsequent changes to
the website after this document
publishes in the Federal Register.) For
alternative registration, please complete
and submit an AFDO Conference
Registration Form, available at https://
burlington.afdo.org/registration.html,
along with a check or money order
payable to AFDO. Please mail your
completed registration form and
payment to: AFDO, 155 West Market St.,
3rd Floor, York, PA 17401. The registrar
will also accept payment through Visa,
MasterCard, and American Express
credit cards. For more information on
the public workshop, or for questions
about registration, please contact AFDO
at 717–757–2888, afdo@afdo.org, or
https://www.afdo.org/conference.
If you need special accommodations
due to a disability, please contact
Krystal Reed (see FOR FURTHER
INFORMATION CONTACT) at least 21 days in
advance of the workshop.
Dated: March 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–05389 Filed 3–15–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Advisory Council on Alzheimer’s
Research, Care, and Services; Meeting
Assistant Secretary for
Planning and Evaluation, HHS.
ACTION: Notice of meeting.
AGENCY:
This notice announces the
public meeting of the Advisory Council
on Alzheimer’s Research, Care, and
Services (Advisory Council). The
Advisory Council on Alzheimer’s
Research, Care, and Services provides
advice on how to prevent or reduce the
burden of Alzheimer’s disease and
related dementias on people with the
disease and their caregivers. During the
April meeting, the Clinical Care
Subcommittee will be taking charge of
the theme, focusing on advancing
consensus on dementia care elements to
SUMMARY:
Registration: You are encouraged to
register by May 1, 2018. Registration
fees cover the cost of facilities,
materials, and breaks. Seats are limited;
therefore, please submit your
registration as soon as possible. Course
space will be filled in order of receipt
of registration. Those accepted into the
course will receive confirmation.
Registration will close after the course is
filled. Registration at the site is not
guaranteed but may be possible on a
space-available basis on the day of the
PO 00000
public workshop beginning at 7:30 a.m.
The cost of registration is as follows:
E:\FR\FM\16MRN1.SGM
16MRN1
]]>Agencies
[Federal Register Volume 83, Number 52 (Friday, March 16, 2018)]
[Notices]
[Page 11761]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05389]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-0757]
Pathways to Global Unity; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA), in collaboration with
the Association of Food and Drug Officials (AFDO), is announcing the
following public workshop entitled ``Pathways to Global Unity.'' This
2\1/2\-day public workshop is intended to provide information about FDA
drug and device regulation to the regulated industries.
DATES: The public workshop will be held on June 11-12, 2018, from 8
a.m. to 5:30 p.m., and on June 13, 2018, from 8 a.m. to 12 p.m.
ADDRESSES: The public workshop will be held at the Doubletree by Hilton
Hotel Burlington Vermont, 870 Williston Rd., Burlington, VT 05403, 802-
865-6626. For directions to the hotel and information on lodging, visit
https://burlington.afdo.org/hotel.html. Attendees are responsible for
their own accommodations.
FOR FURTHER INFORMATION CONTACT: Krystal Reed, Association of Food and
Drug Officials, 155 West Market St., 3rd Floor, York, PA 17401, 717-
757-2888, Fax: 717-650-3650, email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA has made education of the drug and device manufacturing
community a high priority to help ensure the quality of FDA-regulated
drugs and devices. The workshop helps to achieve objectives set forth
in section 406 of the Food and Drug Administration Modernization Act of
1997 (21 U.S.C. 393), which includes working closely with stakeholders
and maximizing the availability and clarity of information to
stakeholders and the public. The workshop also is consistent with the
Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L.
104-121), as outreach activities by government agencies to small
businesses.
II. Topics for Discussion at the Public Workshop
The public workshop helps fulfill the Department of Health and
Human Services and FDA's mission to protect the public health. The
workshop will provide FDA-regulated drug and device entities with
information on a number of topics concerning FDA requirements related
to the production and marketing of drugs and/or devices. The public
workshop's agenda is available at https://www.afdo.org/conference.
Topics for discussion include the following:
FDA Associate Commissioner for Regulatory Affairs Update
Health Canada: Single Audit Program
Enforcement Trends in Drug, Devices, and Compounding Pharmacy
Inspections
FDA Compliance Questions Panel
International Compliance--Industry Perspective
Puerto Rico Emergency Response Update
Artificial Intelligence
Supply Chain Control
Dermal Abyss: Tattoos as Medical Condition Monitors
Design Controls for Combination Products
Benefit Risk--Using Benefit Risk in Making Post-Market
Decisions
III. Participating in the Public Workshop
Registration: You are encouraged to register by May 1, 2018.
Registration fees cover the cost of facilities, materials, and breaks.
Seats are limited; therefore, please submit your registration as soon
as possible. Course space will be filled in order of receipt of
registration. Those accepted into the course will receive confirmation.
Registration will close after the course is filled. Registration at the
site is not guaranteed but may be possible on a space-available basis
on the day of the public workshop beginning at 7:30 a.m. The cost of
registration is as follows:
------------------------------------------------------------------------
Cost of
Category registration
------------------------------------------------------------------------
AFDO Members............................................ $550
AFDO Non-Members........................................ 650
Additional Fee for Registration Postmarked After May 1, 100
2018...................................................
------------------------------------------------------------------------
To register online, please visit https://www.afdo.org/conference
(FDA has verified the website address, but is not responsible for
subsequent changes to the website after this document publishes in the
Federal Register.) For alternative registration, please complete and
submit an AFDO Conference Registration Form, available at https://burlington.afdo.org/registration.html, along with a check or money
order payable to AFDO. Please mail your completed registration form and
payment to: AFDO, 155 West Market St., 3rd Floor, York, PA 17401. The
registrar will also accept payment through Visa, MasterCard, and
American Express credit cards. For more information on the public
workshop, or for questions about registration, please contact AFDO at
717-757-2888, [email protected], or https://www.afdo.org/conference.
If you need special accommodations due to a disability, please
contact Krystal Reed (see FOR FURTHER INFORMATION CONTACT) at least 21
days in advance of the workshop.
Dated: March 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-05389 Filed 3-15-18; 8:45 am]
BILLING CODE 4164-01-P
