The Sentinel Post-Licensure Rapid Immunization Safety Monitoring Program; Public Workshop, 60357-60358 [2016-21046]
Download as PDF
<![CDATA[
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 81, No. 170 / Thursday, September 1, 2016 / Notices
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, email: CRDAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services pursuant to 45 CFR part 11 and
by the General Services Administration,
FDA is announcing the renewal of the
Cardiovascular and Renal Drugs
Advisory Committee. The committee is
a discretionary Federal advisory
committee established to provide advice
to the Commissioner. The
Cardiovascular and Renal Drugs
Advisory Committee advises the
Commissioner or designee in
discharging responsibilities as they
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
the Food and Drug Administration has
regulatory responsibility.
The Committee reviews and evaluates
available data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the treatment of cardiovascular
and renal disorders and makes
appropriate recommendations to the
Commissioner of Food and Drugs.
The Committee shall consist of a core
of 11 voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of
cardiology, hypertension, arrhythmia,
angina, congestive heart failure,
diuresis, and biostatistics. Members will
be invited to serve for overlapping terms
of up to four years. Almost all nonFederal members of this committee
serve as Special Government
Employees. The core of voting members
may include one technically qualified
member, selected by the Commissioner
or designee, who is identified with
consumer interests and is recommended
by either a consortium of consumeroriented organizations or other
interested persons. In addition to the
voting members, the Committee may
include one non-voting member who is
identified with industry interests.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/Drugs/
CardiovascularandRenalDrugs
AdvisoryCommittee/ucm094743.htm or
by contacting the Designated Federal
Officer (see FOR FURTHER INFORMATION
CONTACT). In light of the fact that no
change has been made to the committee
name or description of duties, no
VerDate Sep<11>2014
17:14 Aug 31, 2016
Jkt 238001
amendment will be made to 21 CFR
14.100.
This document is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please visit us at https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: August 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–21041 Filed 8–31–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
The Sentinel Post-Licensure Rapid
Immunization Safety Monitoring
Program; 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 ‘‘The Sentinel
Post-Licensure Rapid Immunization
Safety Monitoring (PRISM) Program.’’
The purpose of the workshop is to
describe the Sentinel Initiative and
PRISM program, illustrate how PRISM
is used by FDA for regulatory
responsibilities (including how it has
been integrated into FDA’s regulatory
review process and case examples), and
discuss the future direction of PRISM in
terms of expansion and further
integration into the regulatory review
process.
SUMMARY:
The public workshop will be
held on December 7, 2016, from 8:30
a.m. to 5 p.m. See the SUPPLEMENTARY
INFORMATION section for registration date
and information.
ADDRESSES: The public workshop will
be held at the National Institutes of
Health, 8600 Rockville Pike, Lister Hill
Center Auditorium, Building 38A,
Bethesda, MD 20894.
FOR FURTHER INFORMATION CONTACT:
Chris Nguyen, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 4124,
Silver Spring, MD 20993–0002; or
Cynthia Whitmarsh, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 4122,
Silver Spring, MD 20993–0002: For
questions, email: CBERPublicEvents@
DATES:
PO 00000
Frm 00020
Fmt 4703
Sfmt 4703
60357
fda.hhs.gov (Subject Line: Sentinel
PRISM Workshop).
SUPPLEMENTARY INFORMATION: The
Sentinel Initiative is FDA’s national
electronic surveillance system for the
post-market safety monitoring of
medical products. The Sentinel System
was implemented as an Active PostMarket Risk Identification and Analysis
program in response to section 905 of
the Food and Drug Administration
Amendments Act of 2007. PRISM was
initiated in 2009 as one of several
national vaccine safety surveillance
systems deployed during the H1N1
influenza pandemic. PRISM was
integrated into the FDA Sentinel
Initiative in September 2010. PRISM has
been used on multiple occasions to
evaluate for vaccine-adverse events,
such as the risk of intussusception
following rotavirus vaccination, and the
risk of febrile seizure among children
receiving the trivalent inactivated
influenza vaccine.
The PRISM distributed database
covers more than 171 million
individuals in a number of data partner
organizations. The database is enhanced
by linkages to State-wide registries and
birth registries. PRISM is being used to
develop broad-based signal detection
tools that can be used to further evaluate
vaccine safety. There are currently
several active vaccine protocol-based
assessments underway. More
information can be found at: https://
www.mini-sentinel.org/assessments/
medical_events/default.aspx.
The workshop will bring together
other government agencies, academia,
industry, and other stakeholder
participants involved in vaccine
development and safety. The goal of the
workshop is to present and discuss the
current capabilities of PRISM. Topics
include: (1) The available data
infrastructure, (2) methods, and (3)
tools. In addition, a few representative
examples of PRISM studies will be
presented to demonstrate the program’s
success in safety signal refinement and
evaluation and informing the regulatory
process. There will also be a discussion
of possible future directions for PRISM.
Registration: Please visit the following
Web site to register for the workshop by
November 23, 2016, midnight Eastern
Standard Time: https://
www.eventbrite.com/e/the-sentinel-postlicensure-rapid-immunization-safetymonitoring-prism-system-publicworkshop-tickets-22494636062. There is
no registration fee for the public
workshop. Early registration is
recommended because seating is
limited. Registrants will receive
confirmation once they have been
E:\FR\FM\01SEN1.SGM
01SEN1
60358
Federal Register / Vol. 81, No. 170 / Thursday, September 1, 2016 / Notices
accepted. FDA may limit the number of
participants from each organization
based on space limitations. Registration
on the day of the public meeting will be
provided on a space available basis
beginning at 8:30 a.m. Those who are
unable to attend the meeting in person
can register to view a live Web cast of
the meeting. You will be asked to
indicate in your registration if you plan
to attend in person or via the Web cast.
FDA will post the agenda approximately
5 days before the workshop at https://
www.fda.gov/BiologicsBloodVaccines/
NewsEvents/
WorkshopsMeetingsConferences/
ucm490175.htm.
If you need special accommodations
because of disability, please contact
Chris Nguyen (see FOR FURTHER
INFORMATION CONTACT) at least 7 days in
advance of the meeting.
Transcripts: Please be advised that as
soon as possible after a transcript of the
public workshop is available, it will be
accessible at: https://www.fda.gov/
BiologicsBloodVaccines/NewsEvents/
WorkshopsMeetingsConferences/
ucm490175.htm.
Dated: August 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–21046 Filed 8–31–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–1660]
Microbiology Devices Panel of the
Medical Devices Advisory Committee;
Notice of Meeting; Establishment of a
Public Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Microbiology Devices
Panel of the Medical Devices Advisory
Committee. The general function of the
committee is to provide advice and
recommendations to the Agency on
FDA’s regulatory issues. The meeting
will be open to the public. FDA is
establishing a docket for public
comment on this document.
DATES: The meeting will be held on
October 5, 2016, from 8 a.m. to 6 p.m.
ADDRESSES: Gaithersburg Holiday Inn,
Ballroom, Two Montgomery Village
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:14 Aug 31, 2016
Jkt 238001
Ave., Gaithersburg, MD 20879. The
hotel’s telephone number is 301–948–
8900. Answers to commonly asked
questions including information
regarding special accommodations due
to a disability, visitor parking, and
transportation may be accessed at:
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm. You may submit
comments as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2016–N–1660 for ‘‘Microbiology Devices
Panel of the Medical Devices Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments.’’ Received
comments will be placed in the docket
PO 00000
Frm 00021
Fmt 4703
Sfmt 4703
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Aden Asefa, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2648, Silver Spring,
MD 20993, aden.asefa@fda.hhs.gov,
301–796–0400, 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
E:\FR\FM\01SEN1.SGM
01SEN1
]]>Agencies
[Federal Register Volume 81, Number 170 (Thursday, September 1, 2016)]
[Notices]
[Pages 60357-60358]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21046]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
The Sentinel Post-Licensure Rapid Immunization Safety Monitoring
Program; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``The Sentinel Post-Licensure Rapid Immunization
Safety Monitoring (PRISM) Program.'' The purpose of the workshop is to
describe the Sentinel Initiative and PRISM program, illustrate how
PRISM is used by FDA for regulatory responsibilities (including how it
has been integrated into FDA's regulatory review process and case
examples), and discuss the future direction of PRISM in terms of
expansion and further integration into the regulatory review process.
DATES: The public workshop will be held on December 7, 2016, from 8:30
a.m. to 5 p.m. See the SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public workshop will be held at the National Institutes
of Health, 8600 Rockville Pike, Lister Hill Center Auditorium, Building
38A, Bethesda, MD 20894.
FOR FURTHER INFORMATION CONTACT: Chris Nguyen, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 4124, Silver Spring, MD 20993-0002; or
Cynthia Whitmarsh, Center for Biologics Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 4122,
Silver Spring, MD 20993-0002: For questions, email:
CBERPublicEvents@fda.hhs.gov (Subject Line: Sentinel PRISM Workshop).
SUPPLEMENTARY INFORMATION: The Sentinel Initiative is FDA's national
electronic surveillance system for the post-market safety monitoring of
medical products. The Sentinel System was implemented as an Active
Post-Market Risk Identification and Analysis program in response to
section 905 of the Food and Drug Administration Amendments Act of 2007.
PRISM was initiated in 2009 as one of several national vaccine safety
surveillance systems deployed during the H1N1 influenza pandemic. PRISM
was integrated into the FDA Sentinel Initiative in September 2010.
PRISM has been used on multiple occasions to evaluate for vaccine-
adverse events, such as the risk of intussusception following rotavirus
vaccination, and the risk of febrile seizure among children receiving
the trivalent inactivated influenza vaccine.
The PRISM distributed database covers more than 171 million
individuals in a number of data partner organizations. The database is
enhanced by linkages to State-wide registries and birth registries.
PRISM is being used to develop broad-based signal detection tools that
can be used to further evaluate vaccine safety. There are currently
several active vaccine protocol-based assessments underway. More
information can be found at: https://www.mini-sentinel.org/assessments/medical_events/default.aspx.
The workshop will bring together other government agencies,
academia, industry, and other stakeholder participants involved in
vaccine development and safety. The goal of the workshop is to present
and discuss the current capabilities of PRISM. Topics include: (1) The
available data infrastructure, (2) methods, and (3) tools. In addition,
a few representative examples of PRISM studies will be presented to
demonstrate the program's success in safety signal refinement and
evaluation and informing the regulatory process. There will also be a
discussion of possible future directions for PRISM.
Registration: Please visit the following Web site to register for
the workshop by November 23, 2016, midnight Eastern Standard Time:
https://www.eventbrite.com/e/the-sentinel-post-licensure-rapid-immunization-safety-monitoring-prism-system-public-workshop-tickets-22494636062. There is no registration fee for the public workshop.
Early registration is recommended because seating is limited.
Registrants will receive confirmation once they have been
[[Page 60358]]
accepted. FDA may limit the number of participants from each
organization based on space limitations. Registration on the day of the
public meeting will be provided on a space available basis beginning at
8:30 a.m. Those who are unable to attend the meeting in person can
register to view a live Web cast of the meeting. You will be asked to
indicate in your registration if you plan to attend in person or via
the Web cast. FDA will post the agenda approximately 5 days before the
workshop at https://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm490175.htm.
If you need special accommodations because of disability, please
contact Chris Nguyen (see FOR FURTHER INFORMATION CONTACT) at least 7
days in advance of the meeting.
Transcripts: Please be advised that as soon as possible after a
transcript of the public workshop is available, it will be accessible
at: https://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm490175.htm.
Dated: August 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21046 Filed 8-31-16; 8:45 am]
BILLING CODE 4164-01-P
