80 FR 70820 - Eighth Annual Sentinel Initiative; Public Workshop; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 220 (November 16, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 220 (November 16, 2015)
| Page Range | 70820-70821 | |
| FR Document | 2015-28851 |
[Federal Register Volume 80, Number 220 (Monday, November 16, 2015)] [Notices] [Pages 70820-70821] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-28851] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-3972] Eighth Annual Sentinel Initiative; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Eighth Annual Sentinel Initiative Public Workshop.'' Convened by the Center for Health Policy 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 update on the state of FDA's Sentinel Initiative, including an overview of the transition from the Mini-Sentinel pilot to the full Sentinel System, and key activities and uses of the Sentinel System accomplished in 2015. In addition, 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. DATES: The public workshop will be held on February 3, 2016, from 9 a.m. to 4 p.m., Eastern Standard Time (EST). Location: The public workshop will be held at the Renaissance Washington, DC Dupont Circle Hotel, 1143 New Hampshire Ave. NW., Washington, DC 20037. For additional travel and hotel information, please refer to http://www.eventbrite.com/e/sentinel-public-event-2016-tickets-19294863456. (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). ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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-2015-N-3972 for ``Eighth Annual Sentinel Initiative; Public Workshop.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://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 [[Page 70821]] claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://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: http://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 http://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 MORE INFORMATION CONTACT: Carlos Bell, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4343, Silver Spring, MD 20993-0002, 301-796-3714, FAX: 301-796-9832, email: SentinelInitiative@fda.hhs.gov. Registration: To attend the public workshop, you must register before February 3, 2016, by visiting http://www.eventbrite.com/e/sentinel-public-event-2016-tickets-19294863456. 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 FOR MORE INFORMATION CONTACT). 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 Renaissance Washington, DC Dupont Circle Hotel. If you need special accommodations due to a disability, please contact Joanna Klatzman at the Brookings Institution (phone: 813-586- 1201, email: jklatzman@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 following the workshop). Persons interested in viewing the live webcast must register online by February 2, 2016, 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 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. Meeting Materials: All event materials will be available to registered attendees via email before the workshop at the Eventbrite Web site at http://www.eventbrite.com/e/sentinel-public-event-2016-tickets-19294863456. Transcripts: Please be advised that transcripts will not be available. Dated: November 9, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-28851 Filed 11-13-15; 8:45 am] BILLING CODE 4164-01-P
![70820 Federal Register / Vol. 80, No. 220 / Monday, November 16, 2015 / Notices
Federalism implications. We have DEPARTMENT OF HEALTH AND Comments submitted electronically,
determined that this notice does not HUMAN SERVICES including attachments, to http://
significantly affect the rights, roles, and www.regulations.gov will be posted to
responsibilities of States. Accordingly, Food and Drug Administration the docket unchanged. Because your
the requirements of Executive Order [Docket No. FDA–2015–N–3972] comment will be made public, you are
13132 do not apply to this notice. solely responsible for ensuring that your
Eighth Annual Sentinel Initiative; comment does not include any
In accordance with the provisions of confidential information that you or a
Public Workshop; Request for
Executive Order 12866, this notice was third party may not wish to be posted,
Comments
reviewed by the Office of Management such as medical information, your or
and Budget. AGENCY: Food and Drug Administration, anyone else’s Social Security number, or
HHS. confidential business information, such
V. Waiver of Proposed Notice
ACTION: Notice of public workshop; as a manufacturing process. Please note
The Medicare statute requires the request for comments. that if you include your name, contact
publication of the monthly actuarial information, or other information that
SUMMARY: The Food and Drug
rates and the Part B premium amounts identifies you in the body of your
Administration (FDA) is announcing a comments, that information will be
in September. We ordinarily use general public workshop entitled ‘‘Eighth
notices, rather than notice and comment posted on http://www.regulations.gov.
Annual Sentinel Initiative Public • If you want to submit a comment
rulemaking procedures, to make such Workshop.’’ Convened by the Center for
announcements. In doing so, we note with confidential information that you
Health Policy at the Brookings do not wish to be made available to the
that, under the Administrative Institution and supported by a public, submit the comment as a
Procedure Act, interpretive rules, cooperative agreement with FDA, this 1- written/paper submission and in the
general statements of policy, and rules day workshop will bring the stakeholder manner detailed (see ‘‘Written/Paper
of agency organization, procedure, or community together to discuss a variety Submissions’’ and ‘‘Instructions’’).
practice are excepted from the of topics on active medical product
requirements of notice and comment surveillance. Topics will include an Written/Paper Submissions
rulemaking. update on the state of FDA’s Sentinel Submit written/paper submissions as
We considered publishing a proposed Initiative, including an overview of the follows:
notice to provide a period for public transition from the Mini-Sentinel pilot • Mail/Hand delivery/Courier (for
to the full Sentinel System, and key written/paper submissions): Division of
comment. However, we may waive that
activities and uses of the Sentinel Dockets Management (HFA–305), Food
procedure if we find, for good cause,
System accomplished in 2015. In and Drug Administration, 5630 Fishers
that prior notice and comment are addition, panelists will discuss the Lane, Rm. 1061, Rockville, MD 20852.
impracticable, unnecessary, or contrary future of the Sentinel System and • For written/paper comments
to the public interest. The statute opportunities to expand its medical submitted to the Division of Dockets
establishes the time period for which product surveillance capabilities. This Management, FDA will post your
the premium rates will apply, and workshop will also engage stakeholders comment, as well as any attachments,
delaying publication of the Part B to discuss current and emerging except for information submitted,
premium rate such that it would not be Sentinel projects. marked and identified, as confidential,
published before that time would be DATES: The public workshop will be if submitted as detailed in
contrary to the public interest. held on February 3, 2016, from 9 a.m. ‘‘Instructions.’’
Moreover, we find that notice and to 4 p.m., Eastern Standard Time (EST). Instructions: All submissions received
comment are unnecessary because the Location: The public workshop will must include the Docket No. FDA–
formulas used to calculate the Part B be held at the Renaissance Washington, 2015–N–3972 for ‘‘Eighth Annual
premiums are statutorily directed. DC Dupont Circle Hotel, 1143 New Sentinel Initiative; Public Workshop.’’
Therefore, we find good cause to waive Hampshire Ave. NW., Washington, DC Received comments will be placed in
publication of a proposed notice and 20037. For additional travel and hotel the docket and, except for those
solicitation of public comments. information, please refer to http:// submitted as ‘‘Confidential
www.eventbrite.com/e/sentinel-public- Submissions,’’ publicly viewable at
Dated: November 6, 2015. http://www.regulations.gov or at the
event-2016-tickets-19294863456. (FDA
Andrew M. Slavitt, has verified the Web site addresses Division of Dockets Management
Acting Administrator, Centers for Medicare throughout this notice, but FDA is not between 9 a.m. and 4 p.m., Monday
& Medicaid Services. responsible for subsequent changes to through Friday.
Dated: November 9, 2015. the Web sites after this document • Confidential Submissions—To
Sylvia M. Burwell, publishes in the Federal Register.) submit a comment with confidential
There will also be a live webcast for information that you do not wish to be
Secretary. Department of Health and Human
those unable to attend the meeting in made publicly available, submit your
Services.
person (see Streaming Webcast of the comments only as a written/paper
[FR Doc. 2015–29181 Filed 11–10–15; 4:15 pm]
Public Workshop). submission. You should submit two
BILLING CODE 4120–01–P
ADDRESSES: You may submit comments copies total. One copy will include the
as follows: information you claim to be confidential
tkelley on DSK3SPTVN1PROD with NOTICES
with a heading or cover note that states
Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
following way: Agency will review this copy, including
• Federal eRulemaking Portal: http:// the claimed confidential information, in
www.regulations.gov. Follow the its consideration of comments. The
instructions for submitting comments. second copy, which will have the
VerDate Sep<11>2014 19:47 Nov 13, 2015 Jkt 238001 PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 E:\FR\FM\16NON1.SGM 16NON1](https://thefederalregister.org/doc/80_FR_71040/page/1.svg)
![Federal Register / Vol. 80, No. 220 / Monday, November 16, 2015 / Notices 70821
claimed confidential information Joanna Klatzman at the Brookings program for FDA’s medical device
redacted/blacked out, will be available Institution (phone: 813–586–1201, review staff, or to contact CDRH for
for public viewing and posted on email: jklatzman@brookings.edu) at more information regarding the ELP
http://www.regulations.gov. Submit least 7 days in advance. General Training Program.
both copies to the Division of Dockets Streaming Webcast of the Public DATES: Submit either an electronic or
Management. If you do not wish your Workshop: This public workshop will written request for participation in the
name and contact information to be also be webcast (archived video footage ELP General Training Program by
made publicly available, you can will be available following the December 16, 2015.
provide this information on the cover workshop). Persons interested in ADDRESSES: Submit either electronic
sheet and not in the body of your viewing the live webcast must register requests to http://www.regulations.gov
comments and you must identify this online by February 2, 2016, at 5 p.m. or written requests to the Division of
information as ‘‘confidential.’’ Any EST. Early registration is recommended Dockets Management (HFA–305), Food
information marked as ‘‘confidential’’ because webcast connections are and Drug Administration, 5630 Fishers
will not be disclosed except in limited. Organizations are requested to Lane, Rm. 1061, Rockville, MD 20852.
accordance with 21 CFR 10.20 and other register all participants but to view Identify proposals with the docket
applicable disclosure law. For more using one connection per location number found in brackets in the
information about FDA’s posting of whenever possible. Webcast heading of this document.
comments to public dockets, see 80 FR participants will be sent technical FOR FURTHER INFORMATION CONTACT:
56469, September 18, 2015, or access system requirements in advance of the Latonya Powell, Center for Devices and
the information at: http://www.fda.gov/ event. Prior to joining the streaming Radiological Health, Food and Drug
regulatoryinformation/dockets/ webcast of the public workshop, it is Administration, 10903 New Hampshire
default.htm. recommended that you review these Ave., Bldg. 32, Rm. 5232, Silver Spring,
Docket: For access to the docket to technical system requirements. MD 20993–0002, 301–796–6965, FAX:
read background documents or the Meeting Materials: All event materials 301–827–3079, Latonya.powell@
electronic and written/paper comments will be available to registered attendees fda.hhs.gov.
received, go to http:// via email before the workshop at the
SUPPLEMENTARY INFORMATION:
www.regulations.gov and insert the Eventbrite Web site at http://
docket number, found in brackets in the www.eventbrite.com/e/sentinel-public- I. Background
heading of this document, into the event-2016-tickets-19294863456. CDRH is responsible for helping to
‘‘Search’’ box and follow the prompts Transcripts: Please be advised that ensure the safety and effectiveness of
and/or go to the Division of Dockets transcripts will not be available. medical devices marketed in the United
Management, 5630 Fishers Lane, Rm. Dated: November 9, 2015. States. Furthermore, CDRH assures that
1061, Rockville, MD 20852. Leslie Kux, patients and providers have timely and
FOR MORE INFORMATION CONTACT: Carlos Associate Commissioner for Policy. continued access to high-quality, safe,
Bell, Center for Drug Evaluation and [FR Doc. 2015–28851 Filed 11–13–15; 8:45 am] and effective medical devices. In
Research, Food and Drug support of this mission, the Center
BILLING CODE 4164–01–P
Administration, 10903 New Hampshire launched various training and
Ave., Bldg. 22, Rm. 4343, Silver Spring, development initiatives to enhance
MD 20993–0002, 301–796–3714, FAX: DEPARTMENT OF HEALTH AND performance of its staff involved in
301–796–9832, email: HUMAN SERVICES regulatory review and in the premarket
SentinelInitiative@fda.hhs.gov. review process. One of these initiatives,
Registration: To attend the public Food and Drug Administration the ELP Pilot, was launched in 2012 and
workshop, you must register before fully implemented on April 2, 2013 (78
February 3, 2016, by visiting http:// [Docket No. FDA–2015–N–0986]
FR 19711).
www.eventbrite.com/e/sentinel-public- CDRH is committed to advancing
Center for Devices and Radiological
event-2016-tickets-19294863456. You regulatory science; providing industry
Health: Experiential Learning Program;
may also register for the live webcast by with predictable, consistent,
General Training Program
visiting this Web page. There will be no transparent, and efficient regulatory
onsite registration. When registering, AGENCY: Food and Drug Administration, pathways; and helping to ensure
please provide the following HHS. consumer confidence in medical
information: Your name, title, company ACTION: Notice. devices marketed in the United States
or organization (if applicable), postal and throughout the world. The ELP
address, telephone number, and email SUMMARY: The Food and Drug General Training Program component is
address. Those without Internet access Administration (FDA), Center for intended to provide CDRH staff with an
should contact Carlos Bell to register Devices and Radiological Health (CDRH opportunity to understand the policies,
(see FOR MORE INFORMATION CONTACT). or Center) is announcing the 2015 laboratory practices, and challenges
There is no registration fee for the Experiential Learning Program (ELP) faced in broader disciplines that impact
public workshop. However, registration General Training Program. This training the device development life cycle. This
will be on a first-come, first-served basis component is intended to provide component is a collaborative effort to
because seating is limited. Therefore, CDRH staff with an opportunity to enhance communication and facilitate
early registration is recommended. A 1- understand the policies, laboratory the premarket review process.
tkelley on DSK3SPTVN1PROD with NOTICES
hour lunch break is scheduled, but food practices, and challenges faced in Furthermore, CDRH is committed to
will not be provided. There are multiple broader disciplines that impact the understanding current industry
restaurants within walking distance of device development life cycle. The practices, innovative technologies,
the Renaissance Washington, DC purpose of this document is to invite regulatory impacts, and regulatory
Dupont Circle Hotel. medical device industry, academia, and needs.
If you need special accommodations health care facilities to request to These formal training visits are not
due to a disability, please contact participate in this formal training intended for FDA to inspect, assess,
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Document Created: 2015-12-14 14:12:28
Document Modified: 2015-12-14 14:12:28
| 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; request for comments. | |
| Dates | The public workshop will be held on February 3, 2016, from 9 a.m. to 4 p.m., Eastern Standard Time (EST). | |
| FR Citation | 80 FR 70820 |
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