81 FR 78607 - Ninth Annual Sentinel Initiative; Public Workshop
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 216 (November 8, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 216 (November 8, 2016)
| Page Range | 78607-78608 | |
| FR Document | 2016-26934 |
[Federal Register Volume 81, Number 216 (Tuesday, November 8, 2016)] [Notices] [Pages 78607-78608] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-26934] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-3631] Ninth Annual Sentinel Initiative; Public Workshop 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 ``Ninth Annual Sentinel Initiative Public Workshop.'' Convened by the Duke-Margolis Center for Health Policy at Duke University 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 current state of Sentinel System safety surveillance activities, and uses of the Sentinel System accomplished in 2016. 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 Initiative projects. DATES: The public workshop will be held on February 2, 2017, from 9 a.m. to 4:30 p.m., Eastern Standard Time (EST). Submit either electronic or written comments by March 2, 2017. ADDRESSES: Location: The public workshop will be held at the Barbara Jordan Conference Center at the Kaiser Family Foundation, 1330 G St. NW., Washington, DC 20005. For additional travel and hotel information, please refer to https://healthpolicy.duke.edu/events/ninth-annual-sentinel-initiative-public-workshop. FDA has verified the meeting 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). 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-2016-N-3631 for ``Ninth 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 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 FURTHER 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: [email protected]. [[Page 78608]] SUPPLEMENTARY INFORMATION: Registration: To attend the public workshop, you must register before February 2, 2017, by visiting https://healthpolicy.duke.edu/events/ninth-annual-sentinel-initiative-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. Those without Internet access should contact Carlos Bell to register (See FOR FURTHER 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. Upon registering, attendees will receive an confirmatory email, containing event materials. A 1-hour lunch break is scheduled, but food will not be provided. There are multiple restaurants within walking distance of the Barbara Jordan Conference Center at the Kaiser Family Foundation. If you need special accommodations due to a disability, please contact Joanna Higgison at the Duke-Margolis Center for Health Policy (phone: 908-432-4872, email: [email protected]) 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 at https://healthpolicy.duke.edu/events/ninth-annual-sentinel-initiative-public-workshop). Persons interested in viewing the live Webcast must register online by February 1, 2017, at 5 p.m. EST. Early registration is recommended because Webcast connections are limited. Organizations are requested to register all participants, and view the workshop using one connection per location whenever possible. Webcast participants will be sent technical system requirements upon registering. 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 sent to registered attendees via email before the workshop. The event materials will also be available to view on the Duke-Margolis Web site at https://healthpolicy.duke.edu/events/ninth-annual-sentinel-initiative-public-workshop. Transcripts: Please be advised that transcripts will not be available. Dated: November 3, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-26934 Filed 11-7-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 216 / Tuesday, November 8, 2016 / Notices 78607
tablet, 180 mg, in the ‘‘Discontinued ADDRESSES: Location: The public Instructions: All submissions received
Drug Product List’’ section of the Orange workshop will be held at the Barbara must include the Docket No. FDA–
Book. The ‘‘Discontinued Drug Product Jordan Conference Center at the Kaiser 2016–N–3631 for ‘‘Ninth Annual
List’’ delineates, among other items, Family Foundation, 1330 G St. NW., Sentinel Initiative; Public Workshop.’’
drug products that have been Washington, DC 20005. For additional Received comments will be placed in
discontinued from marketing for reasons travel and hotel information, please the docket and, except for those
other than safety or effectiveness. refer to https://healthpolicy.duke.edu/ submitted as ‘‘Confidential
ANDAs that refer to CALAN SR events/ninth-annual-sentinel-initiative- Submissions,’’ publicly viewable at
(verapamil hydrochloride) extended- public-workshop. FDA has verified the http://www.regulations.gov or at the
release oral tablet, 180 mg, may be meeting Web site addresses throughout Division of Dockets Management
approved by the Agency as long as they this notice, but FDA is not responsible between 9 a.m. and 4 p.m., Monday
meet all other legal and regulatory for subsequent changes to the Web sites through Friday.
requirements for the approval of after this document publishes in the • Confidential Submissions—To
ANDAs. If FDA determines that labeling Federal Register. There will also be a submit a comment with confidential
for this drug product should be revised live Webcast for those unable to attend information that you do not wish to be
to meet current standards, the Agency the meeting in person (see Streaming made publicly available, submit your
will advise ANDA applicants to submit Webcast of the Public Workshop). comments only as a written/paper
such labeling. You may submit comments as submission. You should submit two
Dated: November 3, 2016. follows: copies total. One copy will include the
Leslie Kux,
information you claim to be confidential
Electronic Submissions with a heading or cover note that states
Associate Commissioner for Policy.
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
[FR Doc. 2016–26932 Filed 11–7–16; 8:45 am]
following way: CONFIDENTIAL INFORMATION.’’ The
BILLING CODE 4164–01–P
• Federal eRulemaking Portal: http:// Agency will review this copy, including
www.regulations.gov. Follow the the claimed confidential information, in
instructions for submitting comments. its consideration of comments. The
DEPARTMENT OF HEALTH AND
Comments submitted electronically, second copy, which will have the
HUMAN SERVICES
including attachments, to http:// claimed confidential information
Food and Drug Administration www.regulations.gov will be posted to redacted/blacked out, will be available
the docket unchanged. Because your for public viewing and posted on http://
[Docket No. FDA–2016–N–3631] comment will be made public, you are www.regulations.gov. Submit both
solely responsible for ensuring that your copies to the Division of Dockets
Ninth Annual Sentinel Initiative; Public Management. If you do not wish your
comment does not include any
Workshop name and contact information to be
confidential information that you or a
AGENCY: Food and Drug Administration, third party may not wish to be posted, made publicly available, you can
HHS. such as medical information, your or provide this information on the cover
ACTION: Notice of public workshop; anyone else’s Social Security number, or sheet and not in the body of your
request for comments. confidential business information, such comments and you must identify this
as a manufacturing process. Please note information as ‘‘confidential.’’ Any
SUMMARY: The Food and Drug that if you include your name, contact information marked as ‘‘confidential’’
Administration (FDA) is announcing a information, or other information that will not be disclosed except in
public workshop entitled ‘‘Ninth identifies you in the body of your accordance with 21 CFR 10.20 and other
Annual Sentinel Initiative Public comments, that information will be applicable disclosure law. For more
Workshop.’’ Convened by the Duke- posted on http://www.regulations.gov. information about FDA’s posting of
Margolis Center for Health Policy at • If you want to submit a comment comments to public dockets, see 80 FR
Duke University and supported by a with confidential information that you 56469, September 18, 2015, or access
cooperative agreement with FDA, this 1- do not wish to be made available to the the information at: http://www.fda.gov/
day workshop will bring the stakeholder public, submit the comment as a regulatoryinformation/dockets/
community together to discuss a variety written/paper submission and in the default.htm.
of topics on active medical product manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
surveillance. Topics will include an Submissions’’ and ‘‘Instructions’’). read background documents or the
update on the state of FDA’s Sentinel electronic and written/paper comments
Initiative, including an overview of the Written/Paper Submissions received, go to http://
current state of Sentinel System safety Submit written/paper submissions as www.regulations.gov and insert the
surveillance activities, and uses of the follows: docket number, found in brackets in the
Sentinel System accomplished in 2016. • Mail/Hand delivery/Courier (for heading of this document, into the
In addition, panelists will discuss the written/paper submissions): Division of ‘‘Search’’ box and follow the prompts
future of the Sentinel System and Dockets Management (HFA–305), Food and/or go to the Division of Dockets
opportunities to expand its medical and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm.
product surveillance capabilities. This Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852.
workshop will also engage stakeholders • For written/paper comments FOR FURTHER INFORMATION CONTACT:
mstockstill on DSK3G9T082PROD with NOTICES
to discuss current and emerging submitted to the Division of Dockets Carlos Bell, Center for Drug Evaluation
Sentinel Initiative projects. Management, FDA will post your and Research, Food and Drug
DATES: The public workshop will be comment, as well as any attachments, Administration, 10903 New Hampshire
held on February 2, 2017, from 9 a.m. except for information submitted, Ave., Bldg. 22, Rm. 4343, Silver Spring,
to 4:30 p.m., Eastern Standard Time marked and identified, as confidential, MD 20993–0002, 301–796–3714, FAX:
(EST). Submit either electronic or if submitted as detailed in 301–796–9832, email:
written comments by March 2, 2017. ‘‘Instructions.’’ SentinelInitiative@fda.hhs.gov.
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![78608 Federal Register / Vol. 81, No. 216 / Tuesday, November 8, 2016 / Notices
SUPPLEMENTARY INFORMATION: Dated: November 3, 2016. former AENT Program will be
Registration: To attend the public Leslie Kux, simplified and used for the ANEW
workshop, you must register before Associate Commissioner for Policy. program.
February 2, 2017, by visiting https:// [FR Doc. 2016–26934 Filed 11–7–16; 8:45 am] HRSA provides advanced education
healthpolicy.duke.edu/events/ninth- BILLING CODE 4164–01–P
nursing grants to educational
annual-sentinel-initiative-public- institutions to increase the numbers of
workshop. You may also register for the advanced education nurses through the
live Webcast by visiting this Web page. DEPARTMENT OF HEALTH AND ANEW Program. The ANEW Program is
There will be no onsite registration. HUMAN SERVICES authorized by Title VIII, Section
When registering, please provide the 811(a)(2) of the Public Health Service
following information: Your name, title, Health Resources and Services Act, (42 U.S.C. 296j(a)(2)), as amended
company or organization (if applicable), Administration by Section 5308 of the Patient
postal address, telephone number, and Protection and Affordable Care Act of
Agency Information Collection 2010, Public Law 111–148. This renewal
email address. Those without Internet
Activities: Proposed Collection: Public with revision request includes the
access should contact Carlos Bell to
Comment Request; The Advanced Project Abstract, Program Narrative,
register (See FOR FURTHER INFORMATION
Education Nursing Traineeship (AENT) Attachments, and Tables. The proposed
CONTACT). There is no registration fee for
Program Specific Data Collection ANEW tables are very similar to the
the public workshop. However, Forms previous AENT tables and include
registration will be on a first-come, first-
information on program participants
served basis because seating is limited. AGENCY: Health Resources and Services
such as the projected number of
Therefore, early registration is Administration (HRSA), Department of
enrollees/trainees receiving traineeship
recommended. Upon registering, Health and Human Services (HHS).
support, projected number of graduates
attendees will receive an confirmatory ACTION: Notice. receiving traineeship support for the
email, containing event materials. A 1- previous fiscal year, the types of
hour lunch break is scheduled, but food SUMMARY: In compliance with the
requirement for opportunity for public programs they are enrolling into and/or
will not be provided. There are multiple from which enrollees/trainees are
restaurants within walking distance of comment on proposed data collection
projects of the Paperwork Reduction Act graduating, and the distribution of
the Barbara Jordan Conference Center at primary care nurse practitioners,
the Kaiser Family Foundation. of 1995), HRSA announces plans to
submit an Information Collection primary care clinical nurse specialists,
If you need special accommodations and nurse-midwives who plan to
Request (ICR), described below, to the
due to a disability, please contact practice in rural and underserved
Office of Management and Budget
Joanna Higgison at the Duke-Margolis settings. To reduce the reporting burden
(OMB). Prior to submitting the ICR to
Center for Health Policy (phone: 908– for applicants, HRSA simplified the
OMB, HRSA seeks comments from the
432–4872, email: joanna.higgison@ tables to focus on the types of providers
public regarding the burden estimate
duke.edu) at least 7 days in advance. and practice settings that are included
below, or any other aspect of the ICR.
Streaming Webcast of the Public in the statute to determine whether
DATES: Comments on this ICR should be
Workshop: This public workshop will applicants qualify for the preference or
received no later than January 9, 2017. special consideration in making awards
also be Webcast (archived video footage
ADDRESSES: Submit your comments to for this program.
will be available following the
paperwork@hrsa.gov or mail the HRSA Need and Proposed Use of the
workshop at https://
Information Collection Clearance Information: The Project Abstract is
healthpolicy.duke.edu/events/ninth-
Officer, Room 14N39, 5600 Fishers often distributed to provide information
annual-sentinel-initiative-public-
Lane, Rockville, MD 20857. to the public and Congress. HRSA will
workshop). Persons interested in
FOR FURTHER INFORMATION CONTACT: To use this information in determining the
viewing the live Webcast must register
online by February 1, 2017, at 5 p.m. request more information on the eligibility for the statutory funding
EST. Early registration is recommended proposed project or to obtain a copy of preference and special consideration
because Webcast connections are the data collection plans and draft and to succinctly capture data for the
limited. Organizations are requested to instruments, email paperwork@hrsa.gov number of projected students for
register all participants, and view the or call the HRSA Information Collection subsequent years in the project period.
workshop using one connection per Clearance Officer at (301) 443–1984. Likely Respondents: Likely
location whenever possible. Webcast SUPPLEMENTARY INFORMATION: When respondents are potential applicants for
participants will be sent technical submitting comments or requesting the ANEW program. Eligible applicants
information, please include the for the ANEW program include entities
system requirements upon registering.
information request collection title for that provide registered nurses with
Prior to joining the streaming Webcast
reference. primary care nurse practitioner (NP),
of the public workshop, it is
Information Collection Request Title: primary care clinical nurse specialist
recommended that you review these
The Advanced Education Nursing (CNS), and nurse-midwife education.
technical system requirements.
Traineeship (AENT) Program Specific Such programs may include accredited
Meeting Materials: All event materials Data Collection Forms. schools of nursing, nursing centers,
will be sent to registered attendees via academic health centers, state or local
email before the workshop. The event OMB No. 0915–0375, Revision governments, and other public or
mstockstill on DSK3G9T082PROD with NOTICES
materials will also be available to view Abstract: The Advanced Nursing private nonprofit entities authorized by
on the Duke-Margolis Web site at Education Workforce (ANEW) Program the Secretary of HHS to confer degrees
https://healthpolicy.duke.edu/events/ is a new program that incorporates to RNs for primary care NP, primary
ninth-annual-sentinel-initiative-public- elements of the AENT and the care CNS, or nurse-midwife education.
workshop. Advanced Nursing Education Programs. Federally recognized Indian Tribal
Transcripts: Please be advised that The current OMB approved Program Government and Native American
transcripts will not be available. Specific Data Collection Forms for the Organizations as well as faith-based or
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Document Created: 2018-02-14 08:23:58
Document Modified: 2018-02-14 08:23:58
| 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 2, 2017, from 9 a.m. to 4:30 p.m., Eastern Standard Time (EST). Submit either electronic or written comments by March 2, 2017. | |
| 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: [email protected] | |
| FR Citation | 81 FR 78607 |
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