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)
Food and Drug Administration
Federal Register Volume 81, Issue 170 (September 1, 2016)
| Page Range | 60357-60358 | |
| FR Document | 2016-21046 |
[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] ----------------------------------------------------------------------- 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: [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] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 170 / Thursday, September 1, 2016 / Notices 60357
Drug Administration, 10903 New amendment will be made to 21 CFR fda.hhs.gov (Subject Line: Sentinel
Hampshire Ave., Bldg. 31, Rm. 2417, 14.100. PRISM Workshop).
Silver Spring, MD 20993–0002, 301– This document is issued under the SUPPLEMENTARY INFORMATION: The
796–9001, email: CRDAC@fda.hhs.gov. Federal Advisory Committee Act (5 Sentinel Initiative is FDA’s national
SUPPLEMENTARY INFORMATION: Pursuant U.S.C. app.). For general information electronic surveillance system for the
to 41 CFR 102–3.65 and approval by the related to FDA advisory committees, post-market safety monitoring of
Department of Health and Human please visit us at http://www.fda.gov/ medical products. The Sentinel System
Services pursuant to 45 CFR part 11 and AdvisoryCommittees/default.htm. was implemented as an Active Post-
by the General Services Administration, Dated: August 26, 2016. Market Risk Identification and Analysis
FDA is announcing the renewal of the Leslie Kux, program in response to section 905 of
Cardiovascular and Renal Drugs Associate Commissioner for Policy. the Food and Drug Administration
Advisory Committee. The committee is [FR Doc. 2016–21041 Filed 8–31–16; 8:45 am]
Amendments Act of 2007. PRISM was
a discretionary Federal advisory initiated in 2009 as one of several
BILLING CODE 4164–01–P
committee established to provide advice national vaccine safety surveillance
to the Commissioner. The systems deployed during the H1N1
Cardiovascular and Renal Drugs DEPARTMENT OF HEALTH AND influenza pandemic. PRISM was
Advisory Committee advises the HUMAN SERVICES integrated into the FDA Sentinel
Commissioner or designee in Initiative in September 2010. PRISM has
discharging responsibilities as they Food and Drug Administration been used on multiple occasions to
relate to helping to ensure safe and evaluate for vaccine-adverse events,
effective drugs for human use and, as [Docket No. FDA–2016–N–0001] such as the risk of intussusception
required, any other product for which following rotavirus vaccination, and the
the Food and Drug Administration has The Sentinel Post-Licensure Rapid risk of febrile seizure among children
regulatory responsibility. Immunization Safety Monitoring receiving the trivalent inactivated
The Committee reviews and evaluates Program; Public Workshop influenza vaccine.
available data concerning the safety and AGENCY: Food and Drug Administration, The PRISM distributed database
effectiveness of marketed and HHS. covers more than 171 million
investigational human drug products for individuals in a number of data partner
ACTION: Notice of public workshop.
use in the treatment of cardiovascular organizations. The database is enhanced
and renal disorders and makes SUMMARY: The Food and Drug by linkages to State-wide registries and
appropriate recommendations to the Administration (FDA) is announcing a birth registries. PRISM is being used to
Commissioner of Food and Drugs. public workshop entitled ‘‘The Sentinel develop broad-based signal detection
The Committee shall consist of a core Post-Licensure Rapid Immunization tools that can be used to further evaluate
of 11 voting members including the Safety Monitoring (PRISM) Program.’’ vaccine safety. There are currently
Chair. Members and the Chair are The purpose of the workshop is to several active vaccine protocol-based
selected by the Commissioner or describe the Sentinel Initiative and assessments underway. More
designee from among authorities PRISM program, illustrate how PRISM information can be found at: http://
knowledgeable in the fields of is used by FDA for regulatory www.mini-sentinel.org/assessments/
cardiology, hypertension, arrhythmia, responsibilities (including how it has medical_events/default.aspx.
angina, congestive heart failure, been integrated into FDA’s regulatory The workshop will bring together
diuresis, and biostatistics. Members will review process and case examples), and other government agencies, academia,
be invited to serve for overlapping terms discuss the future direction of PRISM in industry, and other stakeholder
of up to four years. Almost all non- terms of expansion and further participants involved in vaccine
Federal members of this committee integration into the regulatory review development and safety. The goal of the
serve as Special Government process. workshop is to present and discuss the
Employees. The core of voting members current capabilities of PRISM. Topics
may include one technically qualified DATES: The public workshop will be include: (1) The available data
member, selected by the Commissioner held on December 7, 2016, from 8:30 infrastructure, (2) methods, and (3)
or designee, who is identified with a.m. to 5 p.m. See the SUPPLEMENTARY tools. In addition, a few representative
INFORMATION section for registration date
consumer interests and is recommended examples of PRISM studies will be
by either a consortium of consumer- and information. presented to demonstrate the program’s
oriented organizations or other ADDRESSES: The public workshop will success in safety signal refinement and
interested persons. In addition to the be held at the National Institutes of evaluation and informing the regulatory
voting members, the Committee may Health, 8600 Rockville Pike, Lister Hill process. There will also be a discussion
include one non-voting member who is Center Auditorium, Building 38A, of possible future directions for PRISM.
identified with industry interests. Bethesda, MD 20894. Registration: Please visit the following
Further information regarding the FOR FURTHER INFORMATION CONTACT: Web site to register for the workshop by
most recent charter and other Chris Nguyen, Center for Biologics November 23, 2016, midnight Eastern
information can be found at http:// Evaluation and Research, Food and Standard Time: https://
www.fda.gov/AdvisoryCommittees/ Drug Administration, 10903 New www.eventbrite.com/e/the-sentinel-post-
asabaliauskas on DSK3SPTVN1PROD with NOTICES
CommitteesMeetingMaterials/Drugs/ Hampshire Ave., Bldg. 71, Rm. 4124, licensure-rapid-immunization-safety-
CardiovascularandRenalDrugs Silver Spring, MD 20993–0002; or monitoring-prism-system-public-
AdvisoryCommittee/ucm094743.htm or Cynthia Whitmarsh, Center for Biologics workshop-tickets-22494636062. There is
by contacting the Designated Federal Evaluation and Research, Food and no registration fee for the public
Officer (see FOR FURTHER INFORMATION Drug Administration, 10903 New workshop. Early registration is
CONTACT). In light of the fact that no Hampshire Ave., Bldg. 71, Rm. 4122, recommended because seating is
change has been made to the committee Silver Spring, MD 20993–0002: For limited. Registrants will receive
name or description of duties, no questions, email: CBERPublicEvents@ confirmation once they have been
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![60358 Federal Register / Vol. 81, No. 170 / Thursday, September 1, 2016 / Notices
accepted. FDA may limit the number of Ave., Gaithersburg, MD 20879. The and, except for those submitted as
participants from each organization hotel’s telephone number is 301–948– ‘‘Confidential Submissions,’’ publicly
based on space limitations. Registration 8900. Answers to commonly asked viewable at http://www.regulations.gov
on the day of the public meeting will be questions including information or at the Division of Dockets
provided on a space available basis regarding special accommodations due Management between 9 a.m. and 4 p.m.,
beginning at 8:30 a.m. Those who are to a disability, visitor parking, and Monday through Friday.
unable to attend the meeting in person transportation may be accessed at: • Confidential Submissions—To
can register to view a live Web cast of http://www.fda.gov/ submit a comment with confidential
the meeting. You will be asked to AdvisoryCommittees/ information that you do not wish to be
indicate in your registration if you plan AboutAdvisoryCommittees/ made publicly available, submit your
to attend in person or via the Web cast. ucm408555.htm. You may submit comments only as a written/paper
FDA will post the agenda approximately comments as follows: submission. You should submit two
5 days before the workshop at http:// copies total. One copy will include the
Electronic Submissions
www.fda.gov/BiologicsBloodVaccines/ information you claim to be confidential
NewsEvents/ Submit electronic comments in the with a heading or cover note that states
WorkshopsMeetingsConferences/ following way: ‘‘THIS DOCUMENT CONTAINS
ucm490175.htm. • Federal eRulemaking Portal: http:// CONFIDENTIAL INFORMATION.’’ The
If you need special accommodations www.regulations.gov. Follow the Agency will review this copy, including
because of disability, please contact instructions for submitting comments. the claimed confidential information, in
Chris Nguyen (see FOR FURTHER Comments submitted electronically, its consideration of comments. The
INFORMATION CONTACT) at least 7 days in including attachments, to http:// second copy, which will have the
advance of the meeting. www.regulations.gov will be posted to claimed confidential information
Transcripts: Please be advised that as the docket unchanged. Because your redacted/blacked out, will be available
soon as possible after a transcript of the comment will be made public, you are for public viewing and posted on http://
public workshop is available, it will be solely responsible for ensuring that your www.regulations.gov. Submit both
accessible at: http://www.fda.gov/ comment does not include any copies to the Division of Dockets
BiologicsBloodVaccines/NewsEvents/ confidential information that you or a Management. If you do not wish your
WorkshopsMeetingsConferences/ third party may not wish to be posted, name and contact information to be
ucm490175.htm. such as medical information, your or made publicly available, you can
anyone else’s Social Security number, or provide this information on the cover
Dated: August 26, 2016.
confidential business information, such sheet and not in the body of your
Leslie Kux,
as a manufacturing process. Please note comments and you must identify this
Associate Commissioner for Policy. that if you include your name, contact information as ‘‘confidential.’’ Any
[FR Doc. 2016–21046 Filed 8–31–16; 8:45 am] information, or other information that information marked as ‘‘confidential’’
BILLING CODE 4164–01–P identifies you in the body of your will not be disclosed except in
comments, that information will be accordance with 21 CFR 10.20 and other
posted on http://www.regulations.gov. applicable disclosure law. For more
DEPARTMENT OF HEALTH AND • If you want to submit a comment information about FDA’s posting of
HUMAN SERVICES with confidential information that you comments to public dockets, see 80 FR
do not wish to be made available to the 56469, September 18, 2015, or access
Food and Drug Administration public, submit the comment as a the information at: http://www.fda.gov/
[Docket No. FDA–2016–N–1660] written/paper submission and in the regulatoryinformation/dockets/
manner detailed (see ‘‘Written/Paper default.htm.
Microbiology Devices Panel of the Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
Medical Devices Advisory Committee;
Written/Paper Submissions read background documents or the
Notice of Meeting; Establishment of a
Submit written/paper submissions as electronic and written/paper comments
Public Docket; Request for Comments
follows: received, go to http://
AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
HHS. written/paper submissions): Division of docket number, found in brackets in the
ACTION: Notice; establishment of a Dockets Management (HFA–305), Food heading of this document, into the
public docket; request for comments. and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Division of Dockets
SUMMARY: The Food and Drug • For written/paper comments Management, 5630 Fishers Lane, Rm.
Administration (FDA) announces a submitted to the Division of Dockets 1061, Rockville, MD 20852.
forthcoming public advisory committee Management, FDA will post your FOR FURTHER INFORMATION CONTACT:
meeting of the Microbiology Devices comment, as well as any attachments, Aden Asefa, Center for Devices and
Panel of the Medical Devices Advisory except for information submitted, Radiological Health, Food and Drug
Committee. The general function of the marked and identified, as confidential, Administration, 10903 New Hampshire
committee is to provide advice and if submitted as detailed in Ave., Bldg. 66, Rm. 2648, Silver Spring,
recommendations to the Agency on ‘‘Instructions.’’ MD 20993, aden.asefa@fda.hhs.gov,
asabaliauskas on DSK3SPTVN1PROD with NOTICES
FDA’s regulatory issues. The meeting Instructions: All submissions received 301–796–0400, or FDA Advisory
will be open to the public. FDA is must include the Docket No. FDA– Committee Information Line, 1–800–
establishing a docket for public 2016–N–1660 for ‘‘Microbiology Devices 741–8138 (301–443–0572 in the
comment on this document. Panel of the Medical Devices Advisory Washington, DC area). A notice in the
DATES: The meeting will be held on Committee; Notice of Meeting; Federal Register about last minute
October 5, 2016, from 8 a.m. to 6 p.m. Establishment of a Public Docket; modifications that impact a previously
ADDRESSES: Gaithersburg Holiday Inn, Request for Comments.’’ Received announced advisory committee meeting
Ballroom, Two Montgomery Village comments will be placed in the docket cannot always be published quickly
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Document Created: 2018-02-09 11:57:33
Document Modified: 2018-02-09 11:57:33
| 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 December 7, 2016, from 8:30 a.m. to 5 p.m. See the SUPPLEMENTARY INFORMATION section for registration date and 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). | |
| FR Citation | 81 FR 60357 |
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