82 FR 55619 - Tenth Annual Sentinel Initiative; Public Workshop
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 224 (November 22, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 224 (November 22, 2017)
| Page Range | 55619-55620 | |
| FR Document | 2017-25251 |
[Federal Register Volume 82, Number 224 (Wednesday, November 22, 2017)] [Notices] [Pages 55619-55620] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-25251] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-6230] Tenth Annual Sentinel Initiative; 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 ``Tenth Annual Sentinel Initiative Public Workshop.'' The purpose of this 2-day public workshop is to bring the stakeholder community together to discuss a variety of topics on active medical product surveillance. Attendees will leave with a deeper understanding of how to use the Sentinel System tools to address safety questions. DATES: The public workshop will be held on February 7 and 8, 2018. Day 1 of the public workshop will be held on February 7, 2018, from 9 a.m. to 4:30 p.m. Day 2 of the public workshop will be held on February 8, 2018, from 9 a.m. to 2 p.m. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The public workshop will be held at two separate locations. On Day 1 the public workshop will be held at the Hyatt Regency Bethesda, 1 Bethesda Metro Center, Bethesda, MD 20814. On Day 2 the public workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Rm. 1503 (the Great Room), Silver Spring, MD 20993-0002. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. FOR FURTHER INFORMATION CONTACT: Lieutenant Commander Jamila Mwidau, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 22, Rm. 4481, Silver Spring, MD 20993; 301-796-4989, [email protected]. SUPPLEMENTARY INFORMATION: I. Background The purpose of this 2-day public workshop is to bring the stakeholder community together to discuss a variety of topics on active medical product surveillance. Day 1 will be convened by the Duke- Margolis Center for Health Policy at Duke University with support by a cooperative agreement with FDA. Key discussion topics will include an update on the state of FDA's Sentinel Initiative, key safety surveillance activities, and emerging uses of the Sentinel System. In addition, panelists, representing diverse stakeholder perspectives, will provide comments on Sentinel and opportunities to expand its analytic capabilities. This workshop will also provide an opportunity for stakeholder engagement and input on Sentinel's continued modernization. Day 2 will be a public workshop sponsored by FDA targeting researchers who are experienced in using claims data and will build upon prior public training conducted by FDA on July 10, 2017 (82 FR 19063, April 25, 2017). This second day of the workshop will address more advanced training topics, including Sentinel's inferential analytic capabilities and methods of identifying unexpected safety concerns. Attendees will leave with a deeper understanding of how to use the Sentinel System tools to address safety questions. Attendees are encouraged to review the material FDA presented on July 10, 2017, by visiting the Web site: https://www.sentinelinitiative.org/communications/sentinel-initiative-events/public-sentinel-training-fda. II. Participating in the Public Workshop Registration: To attend the public workshop, you may register for one or both days, but you must register for each day of the workshop separately. The Duke-Margolis Center for Health Policy at Duke University will manage registration for Day 1 and FDA will manage registration for Day 2. Day 1: To attend the public workshop on Day 1, you must register before February 6, 2018, by visiting https://healthpolicy.duke.edu/events/10th-annual-sentinel-public-workshop. 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. There is no registration fee. However, registration will be on a first-come, first-served basis because seating is limited. A 1-hour lunch break is scheduled, but food will not be provided. There are multiple restaurants within walking distance of Hyatt Regency Bethesda. If you need special accommodations due to a disability, please contact Elizabeth Murphy at the Duke- Margolis Center for Health Policy (202-621-2801, email: [email protected]) no later than February 6, 2018. Streaming Webcast for Day 1: The workshop will be webcast (archived video footage will be available following the workshop at https://healthpolicy.duke.edu/events/10th-annual-sentinel-public-workshop). Persons interested in viewing the live webcast must register online before February 6, 2018. Early registration is recommended because webcast connections are limited. Webcast participants will be sent technical system requirements 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. All Day 1 event materials will be available to registered attendees via email before the workshop at the Duke-Margolis Web site at https://healthpolicy.duke.edu/events/10th-annual-sentinel-public-workshop. Day 2: To register to attend Day 2 of the workshop in person or virtually via webcast, you must register before February 6, 2018, by visiting: https://www.eventbrite.com/e/february-8-2018-training-at-fda-tickets-37914164286. Please provide complete contact information for each attendee, including name, title, affiliation, telephone number, and email address. Registration is free and based on space availability, with priority given to early registrants. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. If time and space permit, onsite registration will be provided beginning at 8 a.m. If you need special accommodations due to a disability, please contact Lieutenant Commander Jamila Mwidau no later than January 24, 2018. Streaming Webcast of the Public Workshop Day 2: The FDA training [[Page 55620]] public workshop will also be webcast at https://collaboration.fda.gov/sentinelworkshop. If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit https://www.adobe.com/go/connectpro_overview. FDA has verified the Web site addresses in this document, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. Transcripts: Please be advised that transcripts of the 2-day public workshop will not be available. Dated: November 16, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-25251 Filed 11-21-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 224 / Wednesday, November 22, 2017 / Notices 55619
II. Electronic Access WhiteOakCampusInformation/ may also register for the live webcast by
Persons with access to the internet ucm241740.htm. visiting this Web page. There will be no
may obtain the guidance at either FOR FURTHER INFORMATION CONTACT: onsite registration.
Lieutenant Commander Jamila Mwidau, When registering, please provide the
https://www.fda.gov/Drugs/Guidance
Food and Drug Administration, Center following information: Your name, title,
ComplianceRegulatoryInformation/
company or organization (if applicable),
Guidances/default.htm or https:// for Drug Evaluation and Research,
postal address, telephone number, and
www.regulations.gov. 10903 New Hampshire Ave., Bldg. 22,
email address. There is no registration
Dated: November 16, 2017. Rm. 4481, Silver Spring, MD 20993;
fee. However, registration will be on a
301–796–4989, Jamila.Mwidau@
Anna K. Abram, first-come, first-served basis because
fda.hhs.gov.
Deputy Commissioner for Policy, Planning, seating is limited. A 1-hour lunch break
Legislation, and Analysis. SUPPLEMENTARY INFORMATION: is scheduled, but food will not be
[FR Doc. 2017–25248 Filed 11–21–17; 8:45 am] I. Background provided. There are multiple restaurants
BILLING CODE 4164–01–P within walking distance of Hyatt
The purpose of this 2-day public Regency Bethesda. If you need special
workshop is to bring the stakeholder accommodations due to a disability,
DEPARTMENT OF HEALTH AND community together to discuss a variety please contact Elizabeth Murphy at the
HUMAN SERVICES of topics on active medical product Duke-Margolis Center for Health Policy
surveillance. Day 1 will be convened by (202–621–2801, email:
Food and Drug Administration the Duke-Margolis Center for Health elizabeth.g.murphy@duke.edu) no later
Policy at Duke University with support than February 6, 2018.
[Docket No. FDA–2017–N–6230] by a cooperative agreement with FDA. Streaming Webcast for Day 1: The
Key discussion topics will include an workshop will be webcast (archived
Tenth Annual Sentinel Initiative; Public update on the state of FDA’s Sentinel video footage will be available following
Workshop Initiative, key safety surveillance the workshop at https://
AGENCY: Food and Drug Administration, activities, and emerging uses of the healthpolicy.duke.edu/events/10th-
HHS. Sentinel System. In addition, panelists, annual-sentinel-public-workshop).
representing diverse stakeholder Persons interested in viewing the live
ACTION: Notice of public workshop. perspectives, will provide comments on webcast must register online before
SUMMARY: The Food and Drug Sentinel and opportunities to expand its February 6, 2018. Early registration is
Administration (FDA) is announcing a analytic capabilities. This workshop recommended because webcast
public workshop entitled ‘‘Tenth will also provide an opportunity for connections are limited. Webcast
Annual Sentinel Initiative Public stakeholder engagement and input on participants will be sent technical
Workshop.’’ The purpose of this 2-day Sentinel’s continued modernization. system requirements in advance of the
public workshop is to bring the Day 2 will be a public workshop event. Prior to joining the streaming
stakeholder community together to sponsored by FDA targeting researchers webcast of the public workshop, it is
discuss a variety of topics on active who are experienced in using claims recommended that you review these
medical product surveillance. Attendees data and will build upon prior public technical system requirements.
will leave with a deeper understanding training conducted by FDA on July 10, All Day 1 event materials will be
of how to use the Sentinel System tools 2017 (82 FR 19063, April 25, 2017). This available to registered attendees via
to address safety questions. second day of the workshop will email before the workshop at the Duke-
address more advanced training topics, Margolis Web site at https://
DATES: The public workshop will be
including Sentinel’s inferential analytic healthpolicy.duke.edu/events/10th-
held on February 7 and 8, 2018. Day 1 capabilities and methods of identifying annual-sentinel-public-workshop.
of the public workshop will be held on unexpected safety concerns. Attendees Day 2: To register to attend Day 2 of
February 7, 2018, from 9 a.m. to 4:30 will leave with a deeper understanding the workshop in person or virtually via
p.m. Day 2 of the public workshop will of how to use the Sentinel System tools webcast, you must register before
be held on February 8, 2018, from 9 a.m. to address safety questions. Attendees February 6, 2018, by visiting: https://
to 2 p.m. See the SUPPLEMENTARY are encouraged to review the material www.eventbrite.com/e/february-8-2018-
INFORMATION section for registration date
FDA presented on July 10, 2017, by training-at-fda-tickets-37914164286.
and information. visiting the Web site: https:// Please provide complete contact
ADDRESSES: The public workshop will www.sentinelinitiative.org/ information for each attendee, including
be held at two separate locations. On communications/sentinel-initiative- name, title, affiliation, telephone
Day 1 the public workshop will be held events/public-sentinel-training-fda. number, and email address. Registration
at the Hyatt Regency Bethesda, 1 is free and based on space availability,
Bethesda Metro Center, Bethesda, MD II. Participating in the Public Workshop with priority given to early registrants.
20814. On Day 2 the public workshop Registration: To attend the public Early registration is recommended
will be held at the FDA White Oak workshop, you may register for one or because seating is limited; therefore,
Campus, 10903 New Hampshire Ave., both days, but you must register for each FDA may limit the number of
Bldg. 31, Rm. 1503 (the Great Room), day of the workshop separately. The participants from each organization. If
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Silver Spring, MD 20993–0002. Duke-Margolis Center for Health Policy time and space permit, onsite
Entrance for the public workshop at Duke University will manage registration will be provided beginning
participants (non-FDA employees) is registration for Day 1 and FDA will at 8 a.m.
through Building 1 where routine manage registration for Day 2. If you need special accommodations
security check procedures will be Day 1: To attend the public workshop due to a disability, please contact
performed. For parking and security on Day 1, you must register before Lieutenant Commander Jamila Mwidau
information, please refer to https:// February 6, 2018, by visiting https:// no later than January 24, 2018.
www.fda.gov/AboutFDA/ healthpolicy.duke.edu/events/10th- Streaming Webcast of the Public
WorkingatFDA/BuildingsandFacilities/ annual-sentinel-public-workshop. You Workshop Day 2: The FDA training
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![55620 Federal Register / Vol. 82, No. 224 / Wednesday, November 22, 2017 / Notices
public workshop will also be webcast at Name of Committee: Center for Scientific Name of Committee: Center for Scientific
https://collaboration.fda.gov/ Review Special Emphasis Panel; Member Review Special Emphasis Panel; Member
sentinelworkshop. Conflict: Epidemiology, Ethical and Conflict: Chemo/Dietary Prevention.
If you have never attended a Connect Population Sciences II. Date: December 4, 2017.
Date: December 11, 2017. Time: 3:00 p.m. to 5:00 p.m.
Pro event before, test your connection at Time: 1:00 p.m. to 2:00 p.m. Agenda: To review and evaluate grant
https://collaboration.fda.gov/common/ Agenda: To review and evaluate grant applications.
help/en/support/meeting_test.htm. To applications. Place: National Institutes of Health, 6701
get a quick overview of the Connect Pro Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892
program, visit https://www.adobe.com/ Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).
go/connectpro_overview. FDA has (Telephone Conference Call). Contact Person: Sharon K. Gubanich,
verified the Web site addresses in this Contact Person: Gniesha Yvonne Ph.D., Scientific Review Officer, Center for
document, as of the date this document Dinwiddie, Ph.D., Scientific Review Officer, Scientific Review, National Institutes of
publishes in the Federal Register, but Center for Scientific Review, National Health, 6701 Rockledge Drive, Room 6195D,
Institutes of Health, 6701 Rockledge Drive, MSC 7804, Bethesda, MD 20892, (301) 408–
Web sites are subject to change over Room 3137, Bethesda, MD 20892,
time. 9512, gubanics@csr.nih.gov.
dinwiddiegy@csr.nih.gov.
Transcripts: Please be advised that This notice is being published less than 15
Name of Committee: Center for Scientific days prior to the meeting due to the timing
transcripts of the 2-day public workshop Review Special Emphasis Panel; Member
will not be available. limitations imposed by the review and
Conflict: AIDS and Related Research. funding cycle.
Dated: November 16, 2017. Date: December 13–14, 2017.
Time: 10:00 a.m. to 9:00 p.m. Name of Committee: Center for Scientific
Leslie Kux, Review Special Emphasis Panel; Member
Agenda: To review and evaluate grant
Associate Commissioner for Policy. applications. Conflicts: Pulmonary Diseases.
[FR Doc. 2017–25251 Filed 11–21–17; 8:45 am] Place: National Institutes of Health, 6701 Date: December 5–6, 2017.
BILLING CODE 4164–01–P Rockledge Drive, Bethesda, MD 20892 Time: 8:00 a.m. to 5:00 p.m.
(Virtual Meeting). Agenda: To review and evaluate grant
Contact Person: Kenneth A. Roebuck, applications.
DEPARTMENT OF HEALTH AND Ph.D., Scientific Review Officer, Center for Place: National Institutes of Health, 6701
HUMAN SERVICES Scientific Review, National Institutes of Rockledge Drive, Bethesda, MD 20892
Health, 6701 Rockledge Drive, Room 5106, (Virtual Meeting).
National Institutes of Health MSC 7852, Bethesda, MD 20892, (301) 435– Contact Person: Bradley Nuss, Ph.D.,
1166, roebuckk@csr.nih.gov. Scientific Review Officer, Center for
Center for Scientific Review Notice of (Catalogue of Federal Domestic Assistance Scientific Review, National Institutes of
Program Nos. 93.306, Comparative Medicine; Health, 6701 Rockledge Drive, Room 4142,
Closed Meetings
93.333, Clinical Research, 93.306, 93.333, MSC7814, Bethesda, MD 20892, 301–451–
Pursuant to section 10(d) of the 93.337, 93.393–93.396, 93.837–93.844, 8754, nussb@csr.nih.gov.
Federal Advisory Committee Act, as 93.846–93.878, 93.892, 93.893, National This notice is being published less than 15
amended, notice is hereby given of the Institutes of Health, HHS) days prior to the meeting due to the timing
following meetings. limitations imposed by the review and
Dated: November 16, 2017.
The meetings will be closed to the funding cycle.
David Clary,
public in accordance with the Name of Committee: Center for Scientific
Program Analyst, Office of Federal Advisory Review Special Emphasis Panel; Member
provisions set forth in sections Committee Policy.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Conflict: Cardiovascular Sciences.
[FR Doc. 2017–25215 Filed 11–21–17; 8:45 am] Date: December 6–7, 2017.
as amended. The grant applications and Time: 8:00 a.m. to 5:00 p.m.
BILLING CODE 4140–01–P
the discussions could disclose Agenda: To review and evaluate grant
confidential trade secrets or commercial applications.
property such as patentable material, DEPARTMENT OF HEALTH AND Place: National Institutes of Health, 6701
and personal information concerning HUMAN SERVICES Rockledge Drive, Bethesda, MD 20892
individuals associated with the grant (Virtual Meeting).
applications, the disclosure of which National Institutes of Health Contact Person: Kimm Hamann, Ph.D.,
would constitute a clearly unwarranted Scientific Review Officer, Center for
invasion of personal privacy. Center for Scientific Review Notice of Scientific Review, National Institutes of
Closed Meetings Health, 6701 Rockledge Drive, Room 4118A,
Name of Committee: Center for Scientific MSC 7814, Bethesda, MD 20892, 301–435–
Review Special Emphasis Panel; Small Pursuant to section 10(d) of the 5575, hamannkj@csr.nih.gov.
Business: Musculoskeletal Rehabilitation
Sciences.
Federal Advisory Committee Act, as This notice is being published less than 15
amended, notice is hereby given of the days prior to the meeting due to the timing
Date: December 1, 2017.
following meetings. limitations imposed by the review and
Time: 12:00 p.m. to 1:00 p.m.
The meetings will be closed to the funding cycle.
Agenda: To review and evaluate grant
applications. public in accordance with the (Catalogue of Federal Domestic Assistance
Place: National Institutes of Health, 6701 provisions set forth in sections Program Nos. 93.306, Comparative Medicine;
Rockledge Drive, Bethesda, MD 20892. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 93.333, Clinical Research, 93.306, 93.333,
Contact Person: Baljit S. Moonga, Ph.D., 93.337, 93.393–93.396, 93.837–93.844,
asabaliauskas on DSKBBXCHB2PROD with NOTICES
as amended. The grant applications and 93.846–93.878, 93.892, 93.893, National
Scientific Review Officer, Center for the discussions could disclose
Scientific Review, National Institutes of Institutes of Health, HHS)
Health, 6701 Rockledge Drive, Room 4214,
confidential trade secrets or commercial
property such as patentable material, Dated: November 16, 2017.
MSC 7806, Bethesda, MD 20892, 301–435–
and personal information concerning Melanie J. Pantoja,
1777, moongabs@mail.nih.gov.
individuals associated with the grant Program Analyst, Office of Federal Advisory
This notice is being published less than 15
applications, the disclosure of which Committee Policy.
days prior to the meeting due to the timing
limitations imposed by the review and would constitute a clearly unwarranted [FR Doc. 2017–25216 Filed 11–21–17; 8:45 am]
funding cycle. invasion of personal privacy. BILLING CODE 4140–01–P
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Document Created: 2017-11-22 00:48:54
Document Modified: 2017-11-22 00:48:54
| 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 February 7 and 8, 2018. Day 1 of the public workshop will be held on February 7, 2018, from 9 a.m. to 4:30 p.m. Day 2 of the public workshop will be held on February 8, 2018, from 9 a.m. to 2 p.m. See the SUPPLEMENTARY INFORMATION section for registration date and information. | |
| Contact | Lieutenant Commander Jamila Mwidau, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 22, Rm. 4481, Silver Spring, MD 20993; 301-796-4989, [email protected] | |
| FR Citation | 82 FR 55619 |
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