81 FR 35031 - OpenFDA Public Workshop
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 105 (June 1, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 105 (June 1, 2016)
| Page Range | 35031-35031 | |
| FR Document | 2016-12826 |
[Federal Register Volume 81, Number 105 (Wednesday, June 1, 2016)] [Notices] [Page 35031] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-12826] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] OpenFDA 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: OpenFDA Public Workshop. The purpose of the public workshop is to provide a forum for the openFDA system user community to engage in a robust interactive discussion and provide feedback to FDA regarding openFDA's platform, application programming interfaces (APIs), downloadable harmonized datasets, and possible enhancements to the openFDA platform, as well as to view the demonstration of various applications (apps) specifically developed for utilization of openFDA data. DATES: The public workshop will be held on June 20, 2016, from 9 a.m. to 12 p.m. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The public workshop will be held at FDA's White Oak campus, 10903 New Hampshire Ave., Building 31 (The Great Room 1503A), Silver Spring, MD 20993. For information regarding ground transportation, airports, lodging, driving, and parking, please refer to: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. 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 http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. FOR FURTHER INFORMATION CONTACT: Lonnie Smith, Office of Health Informatics, Office of Chief Scientist, Office of Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-8503, email: [email protected]. SUPPLEMENTARY INFORMATION: OpenFDA, an FDA Office of Health Informatics initiative launched in June 2014, is making it easier for researchers, scientists, web developers, and other FDA regulatory stakeholders to access and use datasets in an open standard format. The project aims to create easy access to public data and a new level of openness and accountability, ensure the privacy and security of public FDA data, educate the public, and save lives. Members of the scientific community can use openFDA to have their applications automatically query the data through APIs. OpenFDA increases the efficiency and speed of accessing datasets by using cutting-edge, open-source code modules in a cloud-based environment. Requests for openFDA app demonstrations: This public workshop includes demonstrations of mobile apps specifically developed for utilization of openFDA data. During registration you may indicate if you wish to provide a demonstration of an app which you have created that utilizes openFDA data. FDA will do its best to accommodate requests to demonstrate openFDA-based apps. The openFDA app demonstrations should not include any presentation slides and, due to FDA internet firewall restrictions, will be limited to only information and displays accessible via apps which can be accessed via internet browsers Internet Explorer version 11 and Firefox versions 6 or higher. All requests to make app demonstrations must be received by 5 p.m., June 6, 2016. FDA will determine the amount of time allotted to each presenter and the approximate time each app demonstration is to begin, and will select and notify participants by 5 p.m., June 10, 2016. If selected for an app demonstration, any demonstration materials must be emailed to Lonnie Smith (see FOR FURTHER INFORMATION CONTACT) no later than 5 p.m., June 16, 2016. No commercial or promotional material will be permitted to be presented or distributed at the public workshop. Registration: There is no registration fee to attend the public workshop. Early registration is recommended because seating is limited, and registration will be on a first-come, first-served basis. There will be no onsite registration. Persons interested in attending this workshop must register by sending the attendee's full name and email address via email message to [email protected] before June 10, 2016. For those without Internet access, please contact Lonnie Smith (see FOR FURTHER INFORMATION CONTACT) to register. Streaming Webcast of the Public Workshop: This public workshop will also be Webcast. Persons interested in viewing the Webcast must register by 4 p.m., June 10, 2016. Early registration is recommended because Webcast connections are limited. Organizations are requested to register all participants, but to view using one connection per location. Webcast participants will be sent technical system requirements after registration and will be sent connection access information after June 10, 2016. If you need special accommodations due to a disability, please contact Lonnie Smith (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance. Dated: May 26, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-12826 Filed 5-31-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 105 / Wednesday, June 1, 2016 / Notices 35031
this applicant seeks 1,186 days of patent INFORMATION section for registration date browsers Internet Explorer version 11
term extension. and information. and Firefox versions 6 or higher. All
III. Petitions ADDRESSES: The public workshop will requests to make app demonstrations
be held at FDA’s White Oak campus, must be received by 5 p.m., June 6,
Anyone with knowledge that any of 10903 New Hampshire Ave., Building 2016. FDA will determine the amount of
the dates as published are incorrect may 31 (The Great Room 1503A), Silver time allotted to each presenter and the
submit either electronic or written Spring, MD 20993. For information approximate time each app
comments and ask for a redetermination regarding ground transportation, demonstration is to begin, and will
(see DATES). Furthermore, any interested airports, lodging, driving, and parking, select and notify participants by 5 p.m.,
person may petition FDA for a please refer to: http://www.fda.gov/ June 10, 2016. If selected for an app
determination regarding whether the AboutFDA/WorkingatFDA/ demonstration, any demonstration
applicant for extension acted with due BuildingsandFacilities/ materials must be emailed to Lonnie
diligence during the regulatory review WhiteOakCampusInformation/
period. To meet its burden, the petition Smith (see FOR FURTHER INFORMATION
ucm241740.htm. Entrance for the public
CONTACT) no later than 5 p.m., June 16,
must be timely (see DATES) and contain workshop participants (non-FDA
sufficient facts to merit an FDA employees) is through Building 1 where 2016. No commercial or promotional
investigation. (See H. Rept. 857, part 1, routine security check procedures will material will be permitted to be
98th Cong., 2d sess., pp. 41–42, 1984.) be performed. For parking and security presented or distributed at the public
Petitions should be in the format information, please refer to http:// workshop.
specified in 21 CFR 10.30. www.fda.gov/AboutFDA/ Registration: There is no registration
Submit petitions electronically to WorkingatFDA/BuildingsandFacilities/ fee to attend the public workshop. Early
http://www.regulations.gov at Docket WhiteOakCampusInformation/ registration is recommended because
No. FDA–2013–S–0610. Submit written ucm241740.htm. seating is limited, and registration will
petitions (two copies are required) to the FOR FURTHER INFORMATION CONTACT: be on a first-come, first-served basis.
Division of Dockets Management (HFA– Lonnie Smith, Office of Health There will be no onsite registration.
305), Food and Drug Administration, Informatics, Office of Chief Scientist, Persons interested in attending this
5630 Fishers Lane, Rm. 1061, Rockville, Office of Commissioner, Food and Drug workshop must register by sending the
MD 20852. Administration, 10903 New Hampshire attendee’s full name and email address
Dated: May 25, 2016. Ave., Silver Spring, MD 20993–0002, via email message to openFDA@
Leslie Kux, 301–796–8503, email: lonnie.smith@ fda.hhs.gov before June 10, 2016. For
Associate Commissioner for Policy. fda.hhs.gov. those without Internet access, please
[FR Doc. 2016–12829 Filed 5–31–16; 8:45 am] SUPPLEMENTARY INFORMATION: OpenFDA, contact Lonnie Smith (see FOR FURTHER
BILLING CODE 4161–01–P an FDA Office of Health Informatics INFORMATION CONTACT) to register.
initiative launched in June 2014, is Streaming Webcast of the Public
making it easier for researchers, Workshop: This public workshop will
DEPARTMENT OF HEALTH AND scientists, web developers, and other
also be Webcast. Persons interested in
HUMAN SERVICES FDA regulatory stakeholders to access
viewing the Webcast must register by 4
and use datasets in an open standard
Food and Drug Administration format. p.m., June 10, 2016. Early registration is
The project aims to create easy access recommended because Webcast
[Docket No. FDA–2016–N–0001] to public data and a new level of connections are limited. Organizations
openness and accountability, ensure the are requested to register all participants,
OpenFDA Public Workshop privacy and security of public FDA data, but to view using one connection per
educate the public, and save lives. location. Webcast participants will be
AGENCY: Food and Drug Administration, Members of the scientific community sent technical system requirements after
HHS. can use openFDA to have their registration and will be sent connection
ACTION: Notice of public workshop. applications automatically query the access information after June 10, 2016.
data through APIs. OpenFDA increases If you need special accommodations
SUMMARY: The Food and Drug
the efficiency and speed of accessing due to a disability, please contact
Administration (FDA) is announcing a
datasets by using cutting-edge, open- Lonnie Smith (see FOR FURTHER
public workshop entitled: OpenFDA
source code modules in a cloud-based
Public Workshop. The purpose of the INFORMATION CONTACT) at least 7 days in
environment.
public workshop is to provide a forum Requests for openFDA app advance.
for the openFDA system user demonstrations: This public workshop Dated: May 26, 2016.
community to engage in a robust includes demonstrations of mobile apps Leslie Kux,
interactive discussion and provide specifically developed for utilization of
feedback to FDA regarding openFDA’s Associate Commissioner for Policy.
openFDA data. During registration you [FR Doc. 2016–12826 Filed 5–31–16; 8:45 am]
platform, application programming may indicate if you wish to provide a
interfaces (APIs), downloadable demonstration of an app which you BILLING CODE 4164–01–P
harmonized datasets, and possible have created that utilizes openFDA data.
enhancements to the openFDA platform, FDA will do its best to accommodate
sradovich on DSK3TPTVN1PROD with NOTICES
as well as to view the demonstration of requests to demonstrate openFDA-based
various applications (apps) specifically apps. The openFDA app demonstrations
developed for utilization of openFDA should not include any presentation
data. slides and, due to FDA internet firewall
DATES: The public workshop will be restrictions, will be limited to only
held on June 20, 2016, from 9 a.m. to 12 information and displays accessible via
p.m. See the SUPPLEMENTARY apps which can be accessed via internet
VerDate Sep<11>2014 21:59 May 31, 2016 Jkt 238001 PO 00000 Frm 00063 Fmt 4703 Sfmt 9990 E:\FR\FM\01JNN1.SGM 01JNN1](https://thefederalregister.org/doc/81_FR_35136/page/1.svg)
Document Created: 2018-02-08 07:27:36
Document Modified: 2018-02-08 07:27:36
| 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 June 20, 2016, from 9 a.m. to 12 p.m. See the SUPPLEMENTARY INFORMATION section for registration date and information. | |
| Contact | Lonnie Smith, Office of Health Informatics, Office of Chief Scientist, Office of Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-8503, email: [email protected] | |
| FR Citation | 81 FR 35031 |
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