Advancing the Development and Implementation of Analysis Data Standards: Key Challenges and Opportunities; Public Workshop, 16023-16025 [2019-07700]
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16023
Federal Register / Vol. 84, No. 74 / Wednesday, April 17, 2019 / Notices
requesting the proposed treatment,
including an explanation of why the
patient lacks other therapeutic options.
• Treatment information, including
the investigational drug’s name and the
name of the entity supplying the drug
(generally the manufacturer), the
applicable FDA review division (if
known), and the treatment plan. This
should include the planned dose, route
and schedule of administration, planned
duration of treatment, monitoring
procedures, and planned modifications
to the treatment plan in the event of
toxicity.
• LOA, generally obtained from the
entity that is the sponsor of the IND
(e.g., commercial sponsor/drug
manufacturer) being referenced, if
applicable.
• Physician’s qualification statement.
An appropriate statement includes
medical school attended, year of
graduation, medical specialty, State
medical license number, current
employment, and job title.
Alternatively, the relevant portion of the
physician’s curriculum vitae may be
attached.
• Physician’s contact information,
including name, physical address, email
address, telephone number, facsimile
number, and physician’s IND number, if
previously issued by FDA.
• Contents of submission (for
followup/additional submissions),
including the type of submission being
made. FDA accepts Form FDA 3926 for
certain followup/additional
submissions, which include the
following: Initial written IND safety
report (§ 312.32(c)); followup to a
written IND safety report (§ 312.32(d));
annual report (§ 312.33); summary of
expanded access use (treatment
completed) (§ 312.310(c)(2)); change in
treatment plan (§ 312.30); general
correspondence or response to FDA
request for information (§ 312.41); and
response to clinical hold (§ 312.42(e)).
• Request for authorization to use
Form FDA 3926 for individual patient
expanded access application.
• Signature of the physician
certifying that treatment will not begin
until 30 days after FDA receives the
completed application and all required
material unless the submitting
physician receives earlier notification
from FDA that the treatment may
proceed. The physician agrees not to
begin or continue clinical investigations
covered by the IND if those studies are
placed on clinical hold. The physician
also certifies that informed consent will
be obtained in compliance with Federal
requirements (including FDA’s
regulations in 21 CFR part 50) and that
an institutional review board (IRB) that
complies with all Federal requirements
(including FDA’s regulations in 21 CFR
part 56) will be responsible for initial
and continuing review and approval of
the expanded access use. The physician
also acknowledges that in the case of an
emergency request, treatment may begin
without prior IRB approval, provided
the IRB is notified of the emergency
treatment within 5 working days of
treatment. The physician agrees to
conduct the investigation in accordance
with all other applicable regulatory
requirements.
In the Federal Register of November
7, 2018 (83 FR 55723), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Guidance on individual patient expanded access
applications: Form FDA 3926
Number of
respondents
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Expanded access submission elements included in Form
FDA 3926 .........................................................................
790
3.03
2,394
0.75 (45
mins.)
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1 There
Total hours
1,795
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection, we are retaining the
currently approved burden estimate.
The estimates for ‘‘number of
respondents,’’ ‘‘number of responses per
respondent,’’ and ‘‘total annual
responses’’ were obtained from reports
and data management systems from the
Center for Drug Evaluation and Research
(CDER) and from other sources familiar
with the number of submissions
received for individual patient
expanded access use under part 312.
The estimates for ‘‘average burden per
response’’ were based on information
CDER provided and personnel of the
U.S. Department of Health and Human
Services familiar with preparing and
reviewing expanded access submissions
by practicing physicians.
Based on data from the Document
Archiving, Reporting, and Regulatory
Tracking System for the number of
submissions to FDA using FDA Form
3926 during fiscal years 2015, 2016, and
2017, we estimate that approximately
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Jkt 247001
790 licensed physicians would use FDA
Form 3926 to submit 1.46 requests per
physician (respondent) for individual
patient expanded access, for a total of
1,153 responses annually. Based on
these estimates, FDA calculates the total
annual responses to be 2,394 (1,153
requests for individual patient
expanded access and 1,241 followup
submissions) by 790 physicians for an
average of 3.03 responses per
respondent. FDA estimates the average
burden per response to be 45 minutes
(0.75 hour). Based on this estimate, FDA
calculates the total burden to be 1,795
hours.
Dated: April 11, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–07711 Filed 4–16–19; 8:45 am]
BILLING CODE 4164–01–P
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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.
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 DukeRobert J. Margolis Center for Health
Policy at Duke University in partnership
with the Critical Path Institute and
supported by a cooperative agreement
SUMMARY:
E:\FR\FM\17APN1.SGM
17APN1
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Federal Register / Vol. 84, No. 74 / Wednesday, April 17, 2019 / Notices
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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, MaryJo.Salerno@fda.hhs.gov.
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
VerDate Sep<11>2014
18:23 Apr 16, 2019
Jkt 247001
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
PO 00000
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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,
sarah.supsiri@duke.edu, 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 DukeMargolis website at https://healthpolicy.
duke.edu/events/analysis-datastandards-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
E:\FR\FM\17APN1.SGM
17APN1
Federal Register / Vol. 84, No. 74 / Wednesday, April 17, 2019 / Notices
and will also be publicly available on
the Duke-Margolis website at https://
healthpolicy.duke.edu/events/analysisdata-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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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National Committee on Vital and Health
Statistics: Meeting
Pursuant to the Federal Advisory
Committee Act, the Department of
Health and Human Services (HHS)
announces the following advisory
committee hearing.
Name: National Committee on Vital
and Health Statistics (NCVHS), Full
Committee Meeting.
Date and Times: Wednesday, June 5,
2019: 9:00 a.m.–5:00 p.m. (EST),
Thursday, June 6, 2019: 8:30 a.m.–3:00
p.m. (EST)
Place: U.S. Department of Health and
Human Services, Hubert H. Humphrey
Building, 200 Independence Avenue
SW, Rm. 505A, Washington, DC 20201.
Status: Open.
Purpose: At the June 5–6, 2019
meeting, the Committee will deliberate
draft recommendations for the HHS
Secretary, move forward on activities
outlined in the NCVHS 2019 workplan,
and hold discussions on several health
data policy topics. Anticipated action
items during this meeting include a
letter that outlines recommendations to
the Secretary and an accompanying
report focused on a framework for
health information privacy and security.
Specifically, the Privacy,
Confidentiality and Security
Subcommittee will provide an update to
the full Committee regarding its working
meeting held in March 2019 focused on
health information privacy and security
beyond the scope of HIPAA. This will
include discussion of a draft report that
will lay out a framework for extending
basic protections for health information
privacy and security, a result of two
years of NCVHS hearings and
deliberations, to understand the
environment and consider what might
be a workable framework that supports
innovative use of health information to
advance health and wellness and
reduces administrative burden, while
protecting the rights of information
subjects. Together with this draft report,
the Subcommittee plans to present a
draft set of recommendations to the
HHS Secretary based on the framework
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put forth in the report for full
Committee deliberation.
The Subcommittee on Standards will
review the timeline of its ICD–11
evaluation project and discuss any
refinements that result from exploration
of existing research on the impact of the
transition to ICD–10, ICD–10–CM, and
ICD–10–PCS. The Subcommittee will
update the full Committee regarding
progress on plans for an August expert
roundtable meeting, which will focus on
identifying research questions HHS
could address to evaluate benefit and
cost of the upcoming transition from
ICD–10 to ICD–11 for mortality and
morbidity. The Subcommittee will
report on continued progress on the
elements of a Predictability Roadmap in
follow up to its December 2018
hearing—the current focus will be on
evaluating the function and purpose of
the Designated Standards Maintenance
Organizations (DSMOs) in light of
changes in the health care standards
environment and the need for
harmonization of administrative and
clinical standards. Finally, the
Subcommittee anticipates continuing
discussion and possible activities in
collaboration with the Office of the
National Coordinator for Health
Information and Technology (ONC)
regarding the opportunity for burden
reduction through convergence of
administrative and clinical data
standards using the prior authorization
transaction as a use-case.
The Subcommittee on Population
Health will provide an update on its
work to address community data needs,
including use-cases, for the full
Committee to consider providing as
input to the Federal Data Strategy. The
Committee will further refine the
remainder of its 2019 workplan and
discuss potential options moving into
fiscal year 2020.
The times and topics are subject to
change. Please refer to the posted
agenda for any updates.
Contact Persons For More
Information: Substantive program
information may be obtained from
Rebecca Hines, MHS, Executive
Secretary, NCVHS, National Center for
Health Statistics, Centers for Disease
Control and Prevention, 3311 Toledo
Road, Hyattsville, Maryland 20782,
telephone (301) 458–4715. Summaries
of meetings and a roster of Committee
members are available on the home page
of the NCVHS website:
www.ncvhs.hhs.gov, where further
information including an agenda and
instructions to access the broadcast of
the meeting will also be posted.
Should you require reasonable
accommodation, please contact the CDC
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16025
Office of Equal Employment
Opportunity on (770) 488–3210 as soon
as possible.
Dated: April 11, 2019.
Sharon Arnold,
Associate Deputy Assistant Secretary for
Planning and Evaluation, Science and Data
Policy, Office of the Assistant Secretary for
Planning and Evaluation.
[FR Doc. 2019–07709 Filed 4–16–19; 8:45 am]
BILLING CODE 4151–05–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel NIAID Clinical Trial
Planning and Implementation Grant (R34 and
U01).
Date: May 23, 2019.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 5601
Fishers Lane, Rockville, MD 20892
(Telephone Conference Call).
Contact Person: Reed Solomon Shabman,
Ph.D., Scientific Review Officer, Scientific
Review Program DEA/NIAID/NIH/DHHS,
5601 Fishers Lane, MSC–9823 Rockville, MD
20852, 240–292–0189, reed.shabman@
nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel NIAID Clinical Trial
Planning and Implementation Grant (R34 and
U01).
Date: June 6, 2019.
Time: 12:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 5601
Fishers Lane, Rockville, MD 20892
(Telephone Conference Call).
Contact Person: Reed Solomon Shabman,
Ph.D., Scientific Review Officer Scientific
Review Program DEA/NIAID/NIH/DHHS,
E:\FR\FM\17APN1.SGM
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]]>Agencies
[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
