Collaborating To Strengthen Food, Drug, and Medical Device Safety Systems; Notice of Conference, 35362 [2016-12942]
Download as PDF
<![CDATA[
35362
Federal Register / Vol. 81, No. 106 / Thursday, June 2, 2016 / Notices
In
compliance with 44 U.S.C. 3507, ACL
has submitted the following proposed
collection of information to OMB for
review and clearance. Grantees are
required by Congress to provide
information for use in program
monitoring and for Government
Performance and Results Act (GPRA)
purposes. This information collection
reports the number of active volunteers,
issues and inquiries received, other
SMP program outreach activities, and
the number of Medicare dollars
recovered, among other SMP
performance outcomes. This
information is used as the primary
method for monitoring the SMP
Projects. ACL estimates the burden of
this collection of information as follows:
Respondents: 54 SMP grantees at 23
hours per month (276 hours per year,
per grantee). Total Estimated Burden
Hours: 7,452 hours per year.
SUPPLEMENTARY INFORMATION:
Dated: May 25, 2016.
Kathy Greenlee,
Administrator and Assistant Secretary for
Aging.
[FR Doc. 2016–12868 Filed 6–1–16; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Collaborating To Strengthen Food,
Drug, and Medical Device Safety
Systems; Notice of Conference
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of conference.
The Food and Drug
Administration (FDA) Philadelphia
District Office, in co-sponsorship with
the Association of Food and Drug
Officials (AFDO), and the North Central
Association of Food and Drug Officials,
is announcing a conference entitled
‘‘Collaborating to Strengthen Food,
Drug, and Medical Device Safety
Systems.’’ This conference is intended
to provide information about FDA drug
and device regulation to the regulated
industry.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
The conference will be held on
June 25 to June 29, 2016. See
SUPPLEMENTARY INFORMATION for meeting
times.
ADDRESSES: The Omni William Penn
Hotel, 530 William Penn Pl., Pittsburgh,
PA 15219. Attendees are responsible for
their own accommodations.
DATES:
VerDate Sep<11>2014
18:30 Jun 01, 2016
Jkt 238001
FOR FURTHER INFORMATION CONTACT:
Randy Young, Association of Food and
Drug Officials, 2550 Kingston Rd., Suite
311, York, PA 17402, 717–757–2888,
FAX: 717–650–3650, ryoung@afdo.org.
SUPPLEMENTARY INFORMATION: FDA has
made education of the food, feed, drug,
and device manufacturing community a
high priority to help ensure the quality
of FDA-regulated products. The
conference 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 for stakeholders and the
public. The conference 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.
The conference helps fulfill the U.S.
Department of Health and Human
Services’ and FDA’s important mission
to protect the public health. The
conference 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. Topics for discussion
include, but are not limited to the
following:
• FDA Program Alignment
• Recalls from the Perspective of the
District
• Inspection of Licensed Producers
under the Marijuana for Medical
Purposes Regulations (Health Canada)
• Foreign inspections
• Regulatory Intelligence
• FDA Inspections: Challenges and
Opportunities (Working Luncheon)
• Drug Shortages
• Drug Supply Chain Act: Wholesale
Drug Distributor and 3rd Party
Logistics Provider
• Medical Device Single Audit Program
• Compliance Questions Panel
The Conference Web site is: https://
afdo.org/conference. The meeting times
are as follows:
Date
June
June
June
June
June
25
26
27
28
29
Meeting time
.......
.......
.......
.......
.......
8
8
8
8
8
a.m.
a.m.
a.m.
a.m.
a.m.
to
to
to
to
to
5 p.m.
6 p.m.
5:30 p.m.
5 p.m.
11:30 a.m.
Registration: The AFDO registration
fees cover the cost of facilities,
materials, and breaks. Seats are limited
and registration will close after the
course is filled; therefore, please submit
your registration as soon as possible.
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
Conference space will be filled in order
of receipt of registration; those accepted
will receive confirmation. Registration
at the site is not guaranteed but may be
possible on a space available basis on
the day of the conference, beginning at
7:30 a.m. The cost of registration
follows:
Category
Cost of
registration
Member ...................................
Non-Member ...........................
Additional Fee for Registration
Postmarked After June 1,
2016 ....................................
$475
575
100
To register, please complete and
submit an AFDO conference registration
form, available at https://pitt.afdo.org/
registration.html, along with a check,
money order payable to ‘‘AFDO’’; the
registrar will also accept Visa and
MasterCard credit cards. Please mail
your completed registration form and
payment to: AFDO, 2550 Kingston Rd.,
Suite 311, York, PA 17402. To register
online, please visit https://pitt.afdo.org/
registration.html (FDA has verified the
Web site address, but is not responsible
for subsequent changes to the Web site
after this document publishes in the
Federal Register.) For more information
on the conference, or for questions
about registration, please contact Randy
Young (see FOR FURTHER INFORMATION
CONTACT), email inquiries will also be
accepted at afdo@afdo.org, or visit
https://www.afdo.org.
If you need special accommodations
due to a disability, please contact Randy
Young (see FOR FURTHER INFORMATION
CONTACT) at least 7 days in advance of
the conference.
Dated: May 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–12942 Filed 6–1–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–P–0378]
Determination That TRIVARIS
(Triamcinolone Acetonide) Injectable
Suspension, 80 Milligrams/Milliliters,
Was Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
SUMMARY:
E:\FR\FM\02JNN1.SGM
02JNN1
]]>Agencies
[Federal Register Volume 81, Number 106 (Thursday, June 2, 2016)]
[Notices]
[Page 35362]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12942]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Collaborating To Strengthen Food, Drug, and Medical Device Safety
Systems; Notice of Conference
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of conference.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) Philadelphia District
Office, in co-sponsorship with the Association of Food and Drug
Officials (AFDO), and the North Central Association of Food and Drug
Officials, is announcing a conference entitled ``Collaborating to
Strengthen Food, Drug, and Medical Device Safety Systems.'' This
conference is intended to provide information about FDA drug and device
regulation to the regulated industry.
DATES: The conference will be held on June 25 to June 29, 2016. See
SUPPLEMENTARY INFORMATION for meeting times.
ADDRESSES: The Omni William Penn Hotel, 530 William Penn Pl.,
Pittsburgh, PA 15219. Attendees are responsible for their own
accommodations.
FOR FURTHER INFORMATION CONTACT: Randy Young, Association of Food and
Drug Officials, 2550 Kingston Rd., Suite 311, York, PA 17402, 717-757-
2888, FAX: 717-650-3650, ryoung@afdo.org.
SUPPLEMENTARY INFORMATION: FDA has made education of the food, feed,
drug, and device manufacturing community a high priority to help ensure
the quality of FDA-regulated products. The conference 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 for stakeholders and the public. The conference 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.
The conference helps fulfill the U.S. Department of Health and
Human Services' and FDA's important mission to protect the public
health. The conference 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. Topics for discussion include, but are not limited to the
following:
FDA Program Alignment
Recalls from the Perspective of the District
Inspection of Licensed Producers under the Marijuana for
Medical Purposes Regulations (Health Canada)
Foreign inspections
Regulatory Intelligence
FDA Inspections: Challenges and Opportunities (Working
Luncheon)
Drug Shortages
Drug Supply Chain Act: Wholesale Drug Distributor and 3rd
Party Logistics Provider
Medical Device Single Audit Program
Compliance Questions Panel
The Conference Web site is: https://afdo.org/conference. The meeting
times are as follows:
------------------------------------------------------------------------
Date Meeting time
------------------------------------------------------------------------
June 25............................. 8 a.m. to 5 p.m.
June 26............................. 8 a.m. to 6 p.m.
June 27............................. 8 a.m. to 5:30 p.m.
June 28............................. 8 a.m. to 5 p.m.
June 29............................. 8 a.m. to 11:30 a.m.
------------------------------------------------------------------------
Registration: The AFDO registration fees cover the cost of
facilities, materials, and breaks. Seats are limited and registration
will close after the course is filled; therefore, please submit your
registration as soon as possible. Conference space will be filled in
order of receipt of registration; those accepted will receive
confirmation. Registration at the site is not guaranteed but may be
possible on a space available basis on the day of the conference,
beginning at 7:30 a.m. The cost of registration follows:
------------------------------------------------------------------------
Cost of
Category registration
------------------------------------------------------------------------
Member.................................................... $475
Non-Member................................................ 575
Additional Fee for Registration Postmarked After June 1, 100
2016.....................................................
------------------------------------------------------------------------
To register, please complete and submit an AFDO conference
registration form, available at https://pitt.afdo.org/registration.html,
along with a check, money order payable to ``AFDO''; the registrar will
also accept Visa and MasterCard credit cards. Please mail your
completed registration form and payment to: AFDO, 2550 Kingston Rd.,
Suite 311, York, PA 17402. To register online, please visit https://pitt.afdo.org/registration.html (FDA has verified the Web site address,
but is not responsible for subsequent changes to the Web site after
this document publishes in the Federal Register.) For more information
on the conference, or for questions about registration, please contact
Randy Young (see FOR FURTHER INFORMATION CONTACT), email inquiries will
also be accepted at afdo@afdo.org, or visit https://www.afdo.org.
If you need special accommodations due to a disability, please
contact Randy Young (see FOR FURTHER INFORMATION CONTACT) at least 7
days in advance of the conference.
Dated: May 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-12942 Filed 6-1-16; 8:45 am]
BILLING CODE 4164-01-P
