83 FR 11761 - Pathways to Global Unity; Public Workshop
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 52 (March 16, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 52 (March 16, 2018)
| Page Range | 11761-11761 | |
| FR Document | 2018-05389 |
[Federal Register Volume 83, Number 52 (Friday, March 16, 2018)] [Notices] [Page 11761] From the Federal Register Online [www.thefederalregister.org] [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 http://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. 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 http://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 http://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 http://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 http://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
![Federal Register / Vol. 83, No. 52 / Friday, March 16, 2018 / Notices 11761
accommodate persons with disabilities. I. Background public workshop beginning at 7:30 a.m.
If you require accommodations due to a FDA has made education of the drug The cost of registration is as follows:
disability, please contact Yinghua Wang and device manufacturing community a
(see FOR FURTHER INFORMATION CONTACT) Cost of
high priority to help ensure the quality Category
at least 7 days in advance of the registration
of FDA-regulated drugs and devices.
meeting. The workshop helps to achieve AFDO Members .................... $550
FDA is committed to the orderly objectives set forth in section 406 of the AFDO Non-Members ............ 650
conduct of its advisory committee Food and Drug Administration Additional Fee for Registra-
meetings. Please visit our website at Modernization Act of 1997 (21 U.S.C. tion Postmarked After May
https://www.fda.gov/ 393), which includes working closely 1, 2018 .............................. 100
AdvisoryCommittees/AboutAdvisory with stakeholders and maximizing the
Committees/ucm111462.htm for To register online, please visit http://
availability and clarity of information to www.afdo.org/conference (FDA has
procedures on public conduct during stakeholders and the public. The
advisory committee meetings. verified the website address, but is not
workshop also is consistent with the responsible for subsequent changes to
Notice of this meeting is given under Small Business Regulatory Enforcement
the Federal Advisory Committee Act (5 the website after this document
Fairness Act of 1996 (Pub. L. 104–121), publishes in the Federal Register.) For
U.S.C. app. 2). as outreach activities by government alternative registration, please complete
Dated: March 13, 2018. agencies to small businesses. and submit an AFDO Conference
Leslie Kux, Registration Form, available at http://
II. Topics for Discussion at the Public
Associate Commissioner for Policy. burlington.afdo.org/registration.html,
Workshop
[FR Doc. 2018–05386 Filed 3–15–18; 8:45 am] along with a check or money order
The public workshop helps fulfill the
BILLING CODE 4164–01–P payable to AFDO. Please mail your
Department of Health and Human
completed registration form and
Services and FDA’s mission to protect
payment to: AFDO, 155 West Market St.,
DEPARTMENT OF HEALTH AND the public health. The workshop will
3rd Floor, York, PA 17401. The registrar
HUMAN SERVICES provide FDA-regulated drug and device
will also accept payment through Visa,
entities with information on a number
MasterCard, and American Express
Food and Drug Administration of topics concerning FDA requirements
credit cards. For more information on
related to the production and marketing
[Docket No. FDA–2018–N–0757] the public workshop, or for questions
of drugs and/or devices. The public
about registration, please contact AFDO
Pathways to Global Unity; Public workshop’s agenda is available at http://
at 717–757–2888, afdo@afdo.org, or
Workshop www.afdo.org/conference. Topics for
http://www.afdo.org/conference.
discussion include the following: If you need special accommodations
AGENCY: Food and Drug Administration, • FDA Associate Commissioner for due to a disability, please contact
HHS. Regulatory Affairs Update Krystal Reed (see FOR FURTHER
ACTION: Notice of public workshop. • Health Canada: Single Audit Program INFORMATION CONTACT) at least 21 days in
• Enforcement Trends in Drug, Devices, advance of the workshop.
SUMMARY: The Food and Drug and Compounding Pharmacy
Administration (FDA), in collaboration Dated: March 13, 2018.
Inspections
with the Association of Food and Drug • FDA Compliance Questions Panel Leslie Kux,
Officials (AFDO), is announcing the • International Compliance—Industry Associate Commissioner for Policy.
following public workshop entitled Perspective [FR Doc. 2018–05389 Filed 3–15–18; 8:45 am]
‘‘Pathways to Global Unity.’’ This 21⁄2- • Puerto Rico Emergency Response BILLING CODE 4164–01–P
day public workshop is intended to Update
provide information about FDA drug • Artificial Intelligence
and device regulation to the regulated • Supply Chain Control DEPARTMENT OF HEALTH AND
industries. • Dermal Abyss: Tattoos as Medical HUMAN SERVICES
DATES: The public workshop will be Condition Monitors
• Design Controls for Combination Advisory Council on Alzheimer’s
held on June 11–12, 2018, from 8 a.m.
Products Research, Care, and Services; Meeting
to 5:30 p.m., and on June 13, 2018, from
8 a.m. to 12 p.m. • Benefit Risk—Using Benefit Risk in AGENCY: Assistant Secretary for
ADDRESSES: The public workshop will Making Post-Market Decisions Planning and Evaluation, HHS.
be held at the Doubletree by Hilton III. Participating in the Public ACTION: Notice of meeting.
Hotel Burlington Vermont, 870 Workshop SUMMARY: This notice announces the
Williston Rd., Burlington, VT 05403,
Registration: You are encouraged to public meeting of the Advisory Council
802–865–6626. For directions to the
register by May 1, 2018. Registration on Alzheimer’s Research, Care, and
hotel and information on lodging, visit
fees cover the cost of facilities, Services (Advisory Council). The
http://burlington.afdo.org/hotel.html.
materials, and breaks. Seats are limited; Advisory Council on Alzheimer’s
Attendees are responsible for their own
therefore, please submit your Research, Care, and Services provides
accommodations.
registration as soon as possible. Course advice on how to prevent or reduce the
daltland on DSKBBV9HB2PROD with NOTICES
FOR FURTHER INFORMATION CONTACT: burden of Alzheimer’s disease and
space will be filled in order of receipt
Krystal Reed, Association of Food and of registration. Those accepted into the related dementias on people with the
Drug Officials, 155 West Market St., 3rd course will receive confirmation. disease and their caregivers. During the
Floor, York, PA 17401, 717–757–2888, Registration will close after the course is April meeting, the Clinical Care
Fax: 717–650–3650, email: kreed@ filled. Registration at the site is not Subcommittee will be taking charge of
afdo.org. guaranteed but may be possible on a the theme, focusing on advancing
SUPPLEMENTARY INFORMATION: space-available basis on the day of the consensus on dementia care elements to
VerDate Sep<11>2014 21:54 Mar 15, 2018 Jkt 244001 PO 00000 Frm 00093 Fmt 4703 Sfmt 4703 E:\FR\FM\16MRN1.SGM 16MRN1](https://thefederalregister.org/doc/83_FR_11813/page/1.svg)
Document Created: 2018-03-16 01:12:02
Document Modified: 2018-03-16 01:12:02
| 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 workshop. | |
| 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. | |
| 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] | |
| FR Citation | 83 FR 11761 |
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