82 FR 40005 - Advancing the Development of Pediatric Therapeutics: Application of “Big Data” to Pediatric Safety Studies; Public Workshop
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 162 (August 23, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 162 (August 23, 2017)
| Page Range | 40005-40005 | |
| FR Document | 2017-17783 |
[Federal Register Volume 82, Number 162 (Wednesday, August 23, 2017)] [Notices] [Page 40005] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-17783] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-2464] Advancing the Development of Pediatric Therapeutics: Application of ``Big Data'' to Pediatric Safety Studies; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. ----------------------------------------------------------------------- SUMMARY: The Office of Pediatric Therapeutics, Food and Drug Administration (FDA), is announcing a public workshop entitled ``Advancing the Development of Pediatric Therapeutics (ADEPT): Application of ``Big Data'' to Pediatric Safety Studies.'' The purpose of this 2-day workshop is to understand how to access and analyze ``Big Data'' associated with safety information in the health care setting, and the utility and challenges associated with the use of ``Big Data'' to study the safety of therapeutics in children. DATES: The public workshop will be held on September 18 and 19, 2017, 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 DoubleTree by Hilton Hotel, 8727 Colesville Rd. (Route 29), Silver Spring, MD 20910. FOR FURTHER INFORMATION CONTACT: Renan A. Bonnel, Office of Pediatric Therapeutics, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-8654, Fax: 301-847-8640, [email protected]. SUPPLEMENTARY INFORMATION: I. Background Large volumes of data in the context of the health care industry have the potential to provide additional information related to medication use, which may affect the benefit-risk assessment of medicines in general and pediatric medicines in particular. Since pediatric pharmacoepidemiologic studies tend to enroll fewer patients than adult studies, additional information may be needed to better understand the safety and efficacy of use of these drugs in children. ``Big Data'', including forms of real world evidence that may involve large and complex data sets, may be particularly useful as a supplement to traditional studies. Supplementary information may include additional clinical trial data, registry data, and electronic health record information. II. Topics for Discussion at the Public Workshop In this workshop, FDA will gather information on the latest developments in ``Big Data'' from the perspective of a number of stakeholders and expand the conversation to include the utility and challenges associated with the use of ``Big Data'' in the pediatric setting. Day 1 will focus on national and international uses of ``Big Data'' in health care. Day 2 will focus on ``Big Data'' utility in the pediatric setting, including specific challenges associated with pediatric data. III. Participation in the Public Workshop Registration: Persons interested in attending this workshop must register online at: https://www.eventbrite.com/e/public-workshop-advancing-the-development-of-pediatric-therapeutics-adept-application-of-big-data-tickets-32470264435 by August 22, 2017. For those without internet access, please contact Renan A. Bonnel (see FOR FURTHER INFORMATION CONTACT) to register. Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register by August 22, 2017. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants. Registration information, the agenda, and additional background materials can be found at https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm545847.htm. If you need special accommodations due to a disability, please contact Renan A. Bonnel (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance. Persons attending the meeting are advised that FDA is not responsible for providing access to electrical outlets. Streaming Webcast of the Public Workshop: This public workshop will also be webcast. September 18: Login URL: https://event.webcasts.com/starthere.jsp?ei=1144352 (morning session). After the morning session, users will be automatically redirected to the afternoon link. Should you lose connection over lunch, please use the following link for the afternoon session (Note: the link for the afternoon session is different from the morning session): Login URL: https://event.webcasts.com/starthere.jsp?ei=1144354 (afternoon session). September 19: Login URL: https://event.webcasts.com/starthere.jsp?ei=1144356 (morning session). After the morning session, users will be automatically redirected to the afternoon link. Should you lose connection over lunch, please use the following link for the afternoon session (Note: the link for the afternoon session is different from the morning session): Login URL: https://event.webcasts.com/starthere.jsp?ei=1144357 (afternoon session). 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 as soon as a transcript of the public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff office (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. A link to the transcript will be available on the internet at https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm545847.htm. Dated: August 17, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-17783 Filed 8-22-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 162 / Wednesday, August 23, 2017 / Notices 40005
Hee V. Choi at least 7 days in advance I. Background A. Bonnel (see FOR FURTHER INFORMATION
of the meeting. Large volumes of data in the context CONTACT) at least 7 days in advance.
FDA is committed to the orderly Persons attending the meeting are
of the health care industry have the
conduct of its advisory committee advised that FDA is not responsible for
potential to provide additional
meetings. Please visit our Web site at providing access to electrical outlets.
information related to medication use,
https://www.fda.gov/ Streaming Webcast of the Public
which may affect the benefit-risk
AdvisoryCommittees/ Workshop: This public workshop will
assessment of medicines in general and
AboutAdvisoryCommittees/ also be webcast.
pediatric medicines in particular. Since
ucm111462.htm for procedures on September 18: Login URL: https://
pediatric pharmacoepidemiologic
public conduct during advisory event.webcasts.com/
studies tend to enroll fewer patients
committee meetings. starthere.jsp?ei=1144352 (morning
Notice of this meeting is given under than adult studies, additional
information may be needed to better session).
the Federal Advisory Committee Act (5 After the morning session, users will
U.S.C. app. 2). understand the safety and efficacy of
use of these drugs in children. ‘‘Big be automatically redirected to the
Dated: August 18, 2017. Data’’, including forms of real world afternoon link. Should you lose
Leslie Kux, evidence that may involve large and connection over lunch, please use the
Associate Commissioner for Policy. complex data sets, may be particularly following link for the afternoon session
[FR Doc. 2017–17856 Filed 8–22–17; 8:45 am] useful as a supplement to traditional (Note: the link for the afternoon session
BILLING CODE 4164–01–P studies. Supplementary information is different from the morning session):
may include additional clinical trial Login URL: https://event.webcasts.com/
data, registry data, and electronic health starthere.jsp?ei=1144354 (afternoon
DEPARTMENT OF HEALTH AND record information. session).
HUMAN SERVICES September 19: Login URL: https://
II. Topics for Discussion at the Public event.webcasts.com/
Food and Drug Administration Workshop starthere.jsp?ei=1144356 (morning
[Docket No. FDA–2017–N–2464] In this workshop, FDA will gather session).
information on the latest developments After the morning session, users will
Advancing the Development of in ‘‘Big Data’’ from the perspective of a be automatically redirected to the
Pediatric Therapeutics: Application of number of stakeholders and expand the afternoon link. Should you lose
‘‘Big Data’’ to Pediatric Safety Studies; conversation to include the utility and connection over lunch, please use the
Public Workshop challenges associated with the use of following link for the afternoon session
‘‘Big Data’’ in the pediatric setting. Day (Note: the link for the afternoon session
AGENCY: Food and Drug Administration,
1 will focus on national and is different from the morning session):
HHS.
international uses of ‘‘Big Data’’ in Login URL: https://event.webcasts.com/
ACTION: Notice of public workshop. health care. Day 2 will focus on ‘‘Big starthere.jsp?ei=1144357 (afternoon
SUMMARY: The Office of Pediatric Data’’ utility in the pediatric setting, session).
Therapeutics, Food and Drug including specific challenges associated If you have never attended a Connect
Administration (FDA), is announcing a with pediatric data. Pro event before, test your connection at
public workshop entitled ‘‘Advancing III. Participation in the Public https://collaboration.fda.gov/common/
the Development of Pediatric Workshop help/en/support/meeting_test.htm. To
Therapeutics (ADEPT): Application of get a quick overview of the Connect Pro
‘‘Big Data’’ to Pediatric Safety Studies.’’ Registration: Persons interested in program, visit https://www.adobe.com/
The purpose of this 2-day workshop is attending this workshop must register go/connectpro_overview. FDA has
to understand how to access and online at: https://www.eventbrite.com/e/ verified the Web site addresses in this
analyze ‘‘Big Data’’ associated with public-workshop-advancing-the- document, as of the date this document
safety information in the health care development-of-pediatric-therapeutics- publishes in the Federal Register, but
setting, and the utility and challenges adept-application-of-big-data-tickets- Web sites are subject to change over
associated with the use of ‘‘Big Data’’ to 32470264435 by August 22, 2017. For time.
study the safety of therapeutics in those without internet access, please Transcripts: Please be advised that as
children. contact Renan A. Bonnel (see FOR soon as a transcript of the public
FURTHER INFORMATION CONTACT) to workshop is available, it will be
DATES: The public workshop will be register.
held on September 18 and 19, 2017, accessible at https://
Registration is free and based on www.regulations.gov. It may be viewed
from 8:30 a.m. to 5 p.m. See the space availability, with priority given to
SUPPLEMENTARY INFORMATION section for at the Dockets Management Staff office
early registrants. Persons interested in (HFA–305), Food and Drug
registration date and information. attending this public workshop must Administration, 5630 Fishers Lane, Rm.
ADDRESSES: The public workshop will register by August 22, 2017. Early 1061, Rockville, MD 20852. A link to
be held at the DoubleTree by Hilton registration is recommended because the transcript will be available on the
Hotel, 8727 Colesville Rd. (Route 29), seating is limited; therefore, FDA may internet at https://www.fda.gov/
Silver Spring, MD 20910.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
limit the number of participants. NewsEvents/
FOR FURTHER INFORMATION CONTACT: Registration information, the agenda, MeetingsConferencesWorkshops/
Renan A. Bonnel, Office of Pediatric and additional background materials ucm545847.htm.
Therapeutics, Food and Drug can be found at https://www.fda.gov/
Administration, 10903 New Hampshire NewsEvents/ Dated: August 17, 2017.
Ave., Silver Spring, MD 20993–0002, MeetingsConferencesWorkshops/ Leslie Kux,
301–796–8654, Fax: 301–847–8640, ucm545847.htm. Associate Commissioner for Policy.
renan.bonnel@fda.hhs.gov. If you need special accommodations [FR Doc. 2017–17783 Filed 8–22–17; 8:45 am]
SUPPLEMENTARY INFORMATION: due to a disability, please contact Renan BILLING CODE 4164–01–P
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Document Created: 2017-08-22 23:51:28
Document Modified: 2017-08-22 23:51:28
| 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. | |
| Dates | The public workshop will be held on September 18 and 19, 2017, from 8:30 a.m. to 5 p.m. See the SUPPLEMENTARY INFORMATION section for registration date and information. | |
| Contact | Renan A. Bonnel, Office of Pediatric Therapeutics, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-8654, Fax: 301-847-8640, [email protected] | |
| FR Citation | 82 FR 40005 |
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