Seventh Annual Sentinel Initiative; Public Workshop, 63130-63131 [2014-25053]
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Federal Register / Vol. 79, No. 204 / Wednesday, October 22, 2014 / Notices
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: October 15, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
I. Background
[FR Doc. 2014–25048 Filed 10–21–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0710]
Guidance for Industry on
Circumstances That Constitute
Delaying, Denying, Limiting, or
Refusing a Drug Inspection;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Circumstances that Constitute
Delaying, Denying, Limiting, or
Refusing a Drug Inspection.’’ The Food
and Drug Administration Safety and
Innovation Act (FDASIA) added a
provision to the Food, Drug, and
Cosmetic Act (the FD&C Act)
concerning inspections that makes a
drug adulterated. This guidance defines
the types of actions, inaction, and
circumstances that FDA considers to
constitute delaying, denying, or limiting
inspection, or refusing to permit entry
or inspection for the purposes of making
a drug adulterated.
DATES: Submit either electronic or
written comments on Agency guidance
at any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Office of Policy and Risk Management,
Office of Regulatory Affairs, Food and
Drug Administration, 12420 Parklawn
Dr., rm. 4138, Rockville, MD 20857.
Send one self-addressed adhesive label
to assist that office in processing your
requests. See the SUPPLEMENTARY
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SUMMARY:
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INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Emily M. Leongini, Office of Policy and
Risk Management, Office of Regulatory
Affairs, Food and Drug Administration,
10902 New Hampshire Ave., Bldg. 32,
rm. 4339, Silver Spring, MD 20903,
301–796–5300.
SUPPLEMENTARY INFORMATION:
FDA is announcing the availability of
a guidance for industry entitled
‘‘Circumstances that Constitute
Delaying, Denying, Limiting, or
Refusing a Drug Inspection.’’ On July 9,
2012, FDASIA (Pub. L. 112–144) was
signed into law. Section 707 of FDASIA
adds 501(j) to the FD&C Act to make a
drug adulterated that ‘‘has been
manufactured, processed, packed, or
held in any factory, warehouse, or
establishment and the owner, operator,
or agent of such factory, warehouse, or
establishment delays, denies, or limits
an inspection, or refuses to permit entry
or inspection.’’ As required by Section
707, FDA is issuing this guidance to
define the types of action, inaction, and
circumstances that FDA considers to
constitute delaying, denying, or limiting
inspection, or refusing to permit entry
or inspection for the purposes of Section
501(j) of the FD&C Act.
In July 2013, FDA issued a draft
guidance for industry of the same title
(78 FR 42387, July 15, 2013). In
response to docket comments, we
revised the guidance to clarify FDA’s
expectations regarding the types of
action, inaction, and circumstances that
make a drug adulterated under 501(j) of
the FD&C Act. Among other things, we
added examples that may constitute
reasonable explanations for actions,
inactions, or circumstances that could
otherwise be considered delaying,
denying, or limiting inspection, or
refusing to permit entry or inspection.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on ‘‘Circumstances that
Constitute Delaying, Denying, Limiting,
or Refusing a Drug Inspection.’’ It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
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satisfies the requirements of the
applicable statutes and regulations.
II. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Regulatory
Information/Guidances/ucm122044.htm
or https://www.regulations.gov.
Dated: October 15, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–25033 Filed 10–21–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Seventh Annual Sentinel Initiative;
Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled ‘‘Seventh Annual Sentinel
Initiative Public Workshop.’’ Convened
by the Engelberg Center for Health Care
Reform at the Brookings Institution and
supported by a cooperative agreement
with FDA, this 1-day workshop will
bring the stakeholder community
together to discuss a variety of topics on
active medical product surveillance.
Topics will include an overview of the
transition from the Mini-Sentinel pilot
program to the full Sentinel System and
what that means for patients and other
critical stakeholders. Additionally,
panelists will discuss the future of the
Sentinel System and opportunities to
expand its medical product surveillance
capabilities. This workshop will also
engage stakeholders to discuss current
and emerging Sentinel projects.
E:\FR\FM\22OCN1.SGM
22OCN1
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Federal Register / Vol. 79, No. 204 / Wednesday, October 22, 2014 / Notices
Date and Time: The public workshop
will be held on February 5, 2015, from
9 a.m. to 4 p.m. EST.
Location: The public workshop will
be held at the Washington Plaza Hotel,
10 Thomas Circle NW., Washington, DC
20005. For additional travel and hotel
information, please refer to https://
events.SignUp4.com/sentinel2015. (FDA
has verified the Web site addresses
throughout this notice, but FDA is not
responsible for subsequent changes to
the Web sites after this document
publishes in the Federal Register.)
There will also be a live Webcast for
those unable to attend the meeting in
person (see Streaming Webcast of the
Public Workshop).
Contact Person: Carlos Bell, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6358,
Silver Spring, MD 20993, 301–796–
3714, FAX: 301–847–3529, email:
SentinelInitiative@fda.hhs.gov.
Registration: To attend the public
workshop, you must register before
February 5, 2015, by visiting https://
events.SignUp4.com/sentinel2015. You
may also register for the live Webcast by
visiting this Web page. There will be no
onsite registration. When registering,
please provide the following
information: Your name, title, company
or organization (if applicable), postal
address, telephone number, and email
address. Those without Internet access
should contact Carlos Bell to register
(see Contact Person). There is no
registration fee for the public workshop.
However, registration will be on a firstcome, first-served basis because seating
is limited. Therefore, early registration
is recommended. A 1-hour lunch break
is scheduled, but food will not be
provided. There are multiple restaurants
within walking distance of the
Washington Plaza Hotel.
If you need special accommodations
due to a disability, please contact
Joanna Klatzman at the Brookings
Institution (202–536–3634, email:
SentinelEvent@Brookings.edu) at least 7
days in advance.
Streaming Webcast of the Public
Workshop: This public workshop will
also be Webcast (archived video footage
will be available on the Brookings
Institution Web site following the
workshop). Persons interested in
viewing the live Webcast must register
online by February 4, 2015, at 5 p.m.
EST. Early registration is recommended
because Webcast connections are
limited. Organizations are requested to
register all participants but to view
using one connection per location
whenever possible. Webcast
participants will be sent technical
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18:22 Oct 21, 2014
Jkt 235001
system requirements and a test link in
advance of the event. Prior to joining the
streaming Webcast of the public
workshop, it is recommended that you
review these technical system
requirements and test your connection.
Meeting Materials: All event materials
will be available to registered attendees
via email before the workshop and will
be posted after the event on the
Brookings Institution event Web site at
https://www.brookings.edu//health/
events.
Transcripts: Please be advised that
transcripts will not be available.
Dated: October 15, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–25053 Filed 10–21–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1617]
Blood Products Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Blood Products
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on December 2, 2014, from 8:30
a.m. to 4:30 p.m. and December 3, 2014,
from 8:30 a.m. to 12:30 p.m.
ADDRESSES: FDA is opening a docket for
person interested in presenting data,
information, or views, orally or in
writing, on issues pending before the
committee. The docket number is FDA–
2014–N–1617. Please see the procedure
section of the notice for further
information.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993.
Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
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63131
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
For those unable to attend in person,
the meeting will also be Web cast. The
Web cast will be available at the
following links:
• December 2, 2014, Blood Products
Advisory Committee Web link:
https://collaboration.fda.gov/
bpac1214/
• December 3, 2014, Blood Products
Advisory Committee Web link:
https://collaboration.fda.gov/bpac
december3/
Contact Person: Bryan Emery or
Joanne Lipkind, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, Bldg. 71, Rm. 6132, 240–402–
8054 or 240–402–8106, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at
https://www.fda.gov/
AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
learn about possible modifications
before coming to the meeting.
Agenda: On December 2, 2014, the
Committee will meet in open session to
hear scientific data related to
reconsideration of the current blood
donor deferral policy for men who have
had sex with another man (MSM) even
one time since 1977. The Committee
will be presented with an update on the
November 13, 2014, meeting of the
Advisory Committee on Blood and
Tissue Safety and Availability where the
MSM blood donor deferral policy will
be discussed. In the afternoon, an
informational presentation will be made
regarding the emergence of chikungunya
virus infections in the Western
Hemisphere and potential implications
for blood transfusion safety. The
Committee will also hear an
informational presentation on the first
survey of the Rapid Donor Surveillance
(RapidDOS) project on Middle Eastern
Respiratory Syndrome coronavirus
(MERS-CoV).
On December 3, 2014, the Blood
Products Advisory Committee will be
seated as a device classification panel.
In open session, the panel will discuss
E:\FR\FM\22OCN1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 204 (Wednesday, October 22, 2014)]
[Notices]
[Pages 63130-63131]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-25053]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0001]
Seventh Annual Sentinel Initiative; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Seventh Annual Sentinel Initiative Public
Workshop.'' Convened by the Engelberg Center for Health Care Reform at
the Brookings Institution and supported by a cooperative agreement with
FDA, this 1-day workshop will bring the stakeholder community together
to discuss a variety of topics on active medical product surveillance.
Topics will include an overview of the transition from the Mini-
Sentinel pilot program to the full Sentinel System and what that means
for patients and other critical stakeholders. Additionally, panelists
will discuss the future of the Sentinel System and opportunities to
expand its medical product surveillance capabilities. This workshop
will also engage stakeholders to discuss current and emerging Sentinel
projects.
[[Page 63131]]
Date and Time: The public workshop will be held on February 5,
2015, from 9 a.m. to 4 p.m. EST.
Location: The public workshop will be held at the Washington Plaza
Hotel, 10 Thomas Circle NW., Washington, DC 20005. For additional
travel and hotel information, please refer to https://events.SignUp4.com/sentinel2015. (FDA has verified the Web site
addresses throughout this notice, but FDA is not responsible for
subsequent changes to the Web sites after this document publishes in
the Federal Register.)
There will also be a live Webcast for those unable to attend the
meeting in person (see Streaming Webcast of the Public Workshop).
Contact Person: Carlos Bell, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6358, Silver Spring, MD 20993, 301-796-3714, FAX: 301-847-3529,
email: SentinelInitiative@fda.hhs.gov.
Registration: To attend the public workshop, you must register
before February 5, 2015, by visiting https://events.SignUp4.com/sentinel2015. You may also register for the live Webcast by visiting
this Web page. There will be no onsite registration. When registering,
please provide the following information: Your name, title, company or
organization (if applicable), postal address, telephone number, and
email address. Those without Internet access should contact Carlos Bell
to register (see Contact Person). There is no registration fee for the
public workshop. However, registration will be on a first-come, first-
served basis because seating is limited. Therefore, early registration
is recommended. A 1-hour lunch break is scheduled, but food will not be
provided. There are multiple restaurants within walking distance of the
Washington Plaza Hotel.
If you need special accommodations due to a disability, please
contact Joanna Klatzman at the Brookings Institution (202-536-3634,
email: SentinelEvent@Brookings.edu) at least 7 days in advance.
Streaming Webcast of the Public Workshop: This public workshop will
also be Webcast (archived video footage will be available on the
Brookings Institution Web site following the workshop). Persons
interested in viewing the live Webcast must register online by February
4, 2015, at 5 p.m. EST. Early registration is recommended because
Webcast connections are limited. Organizations are requested to
register all participants but to view using one connection per location
whenever possible. Webcast participants will be sent technical system
requirements and a test link in advance of the event. Prior to joining
the streaming Webcast of the public workshop, it is recommended that
you review these technical system requirements and test your
connection.
Meeting Materials: All event materials will be available to
registered attendees via email before the workshop and will be posted
after the event on the Brookings Institution event Web site at https://www.brookings.edu//health/events.
Transcripts: Please be advised that transcripts will not be
available.
Dated: October 15, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-25053 Filed 10-21-14; 8:45 am]
BILLING CODE 4164-01-P
