81 FR 60357 - The Sentinel Post-Licensure Rapid Immunization Safety Monitoring Program; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 170 (September 1, 2016)

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.

[Federal Register Volume 81, Number 170 (Thursday, September 1, 2016)]
[Notices]
[Pages 60357-60358]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-21046]


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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.

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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: 
[email protected] (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: http://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 http://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: http://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]
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