[Federal Register Volume 85, Number 83 (Wednesday, April 29, 2020)]
[Notices]
[Pages 23832-23834]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-09045]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-5799]
Modernizing the Food and Drug Administration's Data Strategy;
Public Meeting; Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; extension of comment period.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing a new date, June 30, 2020, for the postponed public meeting
entitled ``Modernizing FDA's Data Strategy'' and extending the comment
period for docket number FDA-2019-N-5799 that appeared in the Federal
Register on January 8, 2020. In the Federal Register notice, FDA
requested comments on the purpose of the meeting, which is related to
possible Agency level approaches to modernizing FDA's data strategy,
including approaches to data quality, data stewardship, data exchange,
and data analytics. The Agency is taking this action in response to the
associated postponed public meeting to allow interested persons
additional time to submit comments.
DATES: The public meeting will be held on June 30, 2020, from 9 a.m. to
5 p.m. Eastern time. The public meeting may be extended or may end
early. FDA is extending the comment period on the Federal Register
notice published January 8, 2020, with docket FDA-2019-N-5799. Submit
either electronic or written comments by July 30, 2020. See the
SUPPLEMENTARY INFORMATION section for registration date and
information.
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ADDRESSES: The public meeting will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Room 1503A), Silver Spring, MD 20993-0002. Entrance for the public
meeting participants (non-FDA employees) is through Building 1, where
routine security check procedures will be performed. For parking and
security information, please refer to https://www.fda.gov/about-fda/white-oak-campus-information/public-meetings-fda-white-oak-campus.
You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before July 30, 2020. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of July 30, 2020. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-2019-N-5799 for ``Modernizing FDA's Data Strategy; Public Meeting;
Request for Comments.'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Jessica Berrellez, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 2308, Silver
Spring, MD 20993, 301-796-0511, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In September 2019, FDA announced its Technology Modernization
Action Plan (TMAP; https://www.fda.gov/about-fda/reports/fdas-technology-modernization-action-plan). The TMAP describes important
near-term actions that FDA is taking to modernize use of technology--
computer hardware, software, data, and analytics--to advance FDA's
public health mission. The TMAP will provide a foundation for
developing a more fluid, agile, and efficient FDA that is responsive to
novel technologies and rapidly increasing workloads.
To achieve these goals, FDA intends to develop a modernized Agency-
wide, strategic approach not only to technology, but to data itself.
Data is at the heart of FDA's work as a science-based Agency, and we
anticipate ongoing, rapid increases in the amount and complexity of the
data that informs FDA's regulatory decision-making process and how we
advance our public health mission. FDA will hold a public meeting on
June 30, 2020, from 9 a.m. to 5 p.m., to provide an opportunity to hear
from FDA staff and outside experts on topics directly related to
modernizing FDA's data strategy, including data quality, data
stewardship, data exchange, and data analytics.
II. Topics for Discussion at the Public Meeting
FDA is gathering scientific and technical information to help
inform its development of an Agency-wide, strategic approach to
modernizing its data strategy, including data quality, data
stewardship, data exchange, and data analytics. The Agency has
determined that a public meeting and an open public docket will
encourage public input and engagement in this important topic.
The Agency welcomes any relevant scientific and technical
information related to FDA's consideration of the following topics:
1. Standards and policy, including:
a. How can FDA best use policy and common data standards to help
ensure the effective and efficient use of data assets?
b. What are the consequences/issues as we move from ``static point-
in-time
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data sets'' to updating digital data streams for analyses?
c. As we move into increased sharing and integrated data sets, how
might FDA manage data in a way that avoids unnecessary duplication?
2. Data security, privacy, and management including:
a. How can FDA modernize its data strategy to continue ensuring
privacy and security of data?
b. What should FDA do to promote the management and organization of
data assets across the Agency, as the amount and complexity of data
(e.g., in regulatory submissions to FDA) is rapidly increasing?
3. Data strategies and data sharing, including:
a. How can FDA's data strategy facilitate broader goals of
integration and interoperability of health care data and scientific
data/virtual patient data generated using scientific models?
b. How can FDA design its data strategy to reflect a global
marketplace and promote clarity to data providers like regulated
industry and other stakeholders?
c. How can FDA design its data strategy and policy development to
facilitate appropriate data access, data sharing within the Agency and
via data sharing agreements, as well as the appropriate reuse and
repurposing of data to advance Agency regulatory science priorities?
d. For stakeholders, including regulated industry that submit data
to FDA, how can FDA enhance the efficiency of the preparation and
submission of data to FDA?
III. Attending and Participating in the Public Meeting
Registration: If you wish to attend this public meeting in person,
please register via https://modernizingdatastrategy.eventbrite.com by 5
p.m. Eastern Time on June 26, 2020. Those without email access can
register to attend in person by contacting Jessica Berrellez at 301-
796-0511 by June 26, 2020 (see FOR FURTHER INFORMATION CONTACT). Please
provide complete contact information for each attendee, including name,
title, affiliation, address, email, and telephone. If you registered
for the March 27, 2020, public meeting, your registration will NOT
carry over and you must register for this as a new meeting. Space will
be limited.
Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
meeting must register by 5 p.m. Eastern Time on June 26, 2020. Early
registration is recommended because seating is limited; therefore, FDA
may limit the number of in-person attendees from each organization.
Given the current uncertainty related to FDA's ability to hold in-
person meetings of more than 10 people on a given future date, it is
possible that this may be converted to a virtual meeting or may be
postponed. Please check the meeting website for the latest information:
https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/modernizing-fdas-data-strategy-03272020-03272020.
If you need special accommodations due to a disability, please
contact [email protected] (see FOR FURTHER INFORMATION
CONTACT) no later than 11:59 p.m. Eastern Time on June 23, 2020.
Participants: FDA is interested in gathering scientific and
technical information from individuals with a broad range of
perspectives on the topics to be discussed at the public meeting.
Participants will include those who submitted nominations through the
Federal Register notice published January 8, 2020, with docket number
FDA-2019-N-5799. They will discuss their scientific and/or technical
knowledge on the questions and presentations in each session.
Participants will be responsible for their own travel arrangements. New
nominations are not being solicited and will not be accepted.
Streaming Webcast of the Public Meeting: This public meeting will
also be webcast. Please register for the streaming webcast of the
workshop via https://modernizingdatastrategy.eventbrite.com by 5 p.m.
Eastern Time on June 26, 2020. Pre-registration for the webcast is
recommended, but not required. This is a new registration. If you
registered for the March 27, 2020, public meeting, your registration
will NOT carry over. The webcast will be available and active during
the public meeting at https://collaboration.fda.gov/data063020/. In the
event that this meeting is converted to a virtual meeting, options for
remote participation may change. Please check the meeting website for
the latest information: https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/modernizing-fdas-data-strategy-03272020-03272020.
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 website addresses in this document, as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.
An agenda for the public meeting and any other background materials
will be made available 5 days before the public meeting at https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/modernizing-fdas-data-strategy-03272020-03272020.
Persons attending FDA's meetings are advised that the Agency is not
responsible for providing access to electrical outlets.
Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/modernizing-fdas-data-strategy-03272020-03272020.
Dated: April 23, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-09045 Filed 4-28-20; 8:45 am]
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