[Federal Register Volume 84, Number 74 (Wednesday, April 17, 2019)]
[Notices]
[Pages 16023-16025]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07700]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0001]


Advancing the Development and Implementation of Analysis Data 
Standards: Key Challenges and Opportunities; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following public workshop entitled ``Advancing the Development and 
Implementation of Analysis Data Standards: Key Challenges and 
Opportunities.'' Convened by the Duke-Robert J. Margolis Center for 
Health Policy at Duke University in partnership with the Critical Path 
Institute and supported by a cooperative agreement

[[Page 16024]]

with FDA, the purpose of the public workshop is to bring the 
stakeholder community together to discuss challenges and opportunities 
to advance the development and application of analysis data standards 
in drug development and regulatory review. This public workshop is 
being organized to fulfill FDA's commitment in section (I)(J)(5)(c) of 
the Prescription Drug User Fee Reauthorization Performance Goals and 
Procedures Fiscal Years 2018 through 2022 (PDUFA VI goals letter; 
available at https://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm511438.pdf) to convene a public workshop to 
advance the development and application of analysis data standards. FDA 
will use the information from this public workshop to inform ongoing 
and future analysis data standards initiatives and strategic planning 
to improve the efficiency of regulatory review of electronic 
submissions.

DATES: The public workshop will be held on June 12, 2019, from 9 a.m. 
to 4:30 p.m. See the SUPPLEMENTARY INFORMATION section for registration 
date and information.

ADDRESSES: The public workshop will be held at the Tommy Douglas 
Conference Center, 10000 New Hampshire Ave., Silver Spring, MD 20903. 
For more information, please check the following website: https://www.tommydouglascenter.com/. There will also be a live webcast for 
those unable to attend the meeting in person (see Streaming Webcast of 
the Public Workshop).

FOR FURTHER INFORMATION CONTACT: Mary Jo Salerno, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 21, Rm. 3541, Silver Spring, MD 20993-0002, 240-
402-0420, [email protected]. If contacting in writing, please 
use the subject line ``Analysis Data Standards Public Workshop.''

SUPPLEMENTARY INFORMATION: 

I. Background

    Study data standards describe a standard way to exchange clinical 
and nonclinical research data between computer systems. These standards 
provide a consistent general framework for organizing study data, 
including templates for datasets, standard names for variables, and 
standard ways of doing calculations with common variables. Establishing 
common study data standards provides new opportunities to transform the 
vast, diverse, and continually increasing amount of clinical study data 
into useful information to speed the delivery of new therapies to 
patients. Having standard, uniform study data enables FDA scientists to 
combine data from multiple studies to explore many new research 
questions and gain new insights. Data standards also help FDA receive, 
process, review, and archive submissions more efficiently and 
effectively by preventing submission reviewers from having to navigate 
a high volume of less-structured data, which allows reviewers more time 
to focus on the scientific review.
    The Center for Drug Evaluation and Research (CDER) established the 
Data Standards Program in 2010. The program has led CDER's efforts to 
standardize data and has helped FDA meet its commitments in the 
Prescription Drug User Fee Act Reauthorization Performance Goals and 
Procedures Fiscal Years 2013 through 2017 (PDUFA V). Accomplishments to 
date include the following: (1) Publication of a final guidance 
entitled ``Providing Regulatory Submissions in Electronic Format--eCTD 
Specifications''; developing a repeatable test process to ensure data 
standards meet FDA needs; (2) working with FDA's Center for Biologics 
Evaluation and Research to compile a prioritized list of disease and 
therapeutic areas for which additional data standardization is needed; 
and (3) working with partners to develop a series of use cases for 
clinical study data related to Human Immunodeficiency Virus therapies, 
vaccines, and comparative clinical endpoint bioequivalence studies.
    Standards models that span the data lifecycle from data collection 
(e.g., Clinical Data Acquisition Standards Harmonization (CDASH)) to 
tabulated representation (e.g., Standard for the Exchange of 
Nonclinical Data (SEND) and Study Data Tabulation Model (SDTM)) are 
foundational for analysis data standards (e.g., Analysis Data Model 
(ADaM)). FDA is conducting this public workshop to support the PDUFA VI 
goals to advance the development and application of analysis data 
standards.

II. Topics for Discussion at the Public Workshop

    During the public workshop, speakers and participants will address 
a range of issues related to the development and implementation of 
analysis data standards. Items for discussion will include stakeholder 
experience implementing analysis data standards in electronic 
submissions. Input will be sought on the key challenges and 
opportunities to: (1) Improve the efficiency, predictability, and 
quality of data submissions; (2) support data traceability; and (3) 
support optimal implementation of analysis data standards. Input will 
also be sought on approaches to reduce the variability of formats used 
to submit study data, improve the integration of data across studies, 
and enable the use of data from sources other than traditional clinical 
trials.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, visit the 
following website: https://healthpolicy.duke.edu/events/analysis-data-standards-workshop. Please provide complete contact information for 
each attendee, including name, title, affiliation, address, email, and 
telephone.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
workshop must register online by June 10, 2019, midnight Eastern Time. 
There will be no onsite registration. Early registration is recommended 
because seating is limited; therefore, FDA may limit the number of 
participants from each organization. Duke-Margolis will post on its 
website if registration closes before the day of the public workshop.
    If you need special accommodations due to a disability, please 
contact Sarah Supsiri at the Duke-Margolis Center for Health Policy, 
202-791-9561, [email protected], no later than June 5, 2019.
    Streaming Webcast of the Public Workshop: This public workshop will 
also be webcast. Webcast participants will be able to submit questions 
and comments via the webcast portal. Following the workshop, archived 
video footage will be available on the Duke-Margolis website at https://healthpolicy.duke.edu/events/analysis-data-standards-workshop. 
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. Before joining the streaming webcast of the public workshop, 
we recommend that you review these technical system requirements. FDA 
has verified the website addresses in this document, as of the date 
this document publishes in the Federal Register, but websites are 
subject to change over time.
    Transcripts: Please be advised that transcripts will not be 
available.
    Workshop Materials: All event materials will be provided to 
registered attendees via email before the workshop

[[Page 16025]]

and will also be publicly available on the Duke-Margolis website at 
https://healthpolicy.duke.edu/events/analysis-data-standards-workshop.

    Dated: April 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-07700 Filed 4-16-19; 8:45 am]
 BILLING CODE 4164-01-P