Document ID: FDA-2019-N-5799-0001
Agency: fda
Document Type: Notice
Title: Modernizing the Food and Drug Administration’s Data Strategy; Public Meeting; Request for Comments
Posted Date: 2020-01-08T05:00Z

[Federal Register Volume 85, Number 5 (Wednesday, January 8, 2020)]
[Notices]
[Pages 924-926]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00071]

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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; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the following public meeting entitled ``Modernizing FDA's 
Data Strategy.'' The purpose of the public meeting and the request for 
comments is to discuss possible Agency level approaches to modernizing 
FDA's data strategy, including approaches to data quality, data 
stewardship, data exchange, and data analytics.

DATES: The public meeting will be held on March 27, 2020, from 9 a.m. 
to 5 p.m. Eastern time. The public meeting may be extended or may end 
early. Submit electronic or written comments on this public meeting by 
April 30, 2020. See the SUPPLEMENTARY INFORMATION section for 
registration date and information.

ADDRESSES: The public meeting will be held at the FDA White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room 
(Rooms 1503B/C), 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 April 30, 2020. The https://www.regulations.gov 
electronic filing system will accept comments until 11:59 p.m. Eastern 
Time at the end of April 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

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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, Jessica.Berrellez@fda.hhs.gov.

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 
March 27, 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 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. Participating in the Public Meeting

    Registration: If you wish to attend this public meeting in person, 
please register via https://fdapublicmeetingmodernizingdatastrategy.eventbrite.com by 11:59 p.m. 
Eastern Time on March 24, 2020. Those without email access can register 
to attend in person by contacting Jessica Berrellez at 301-796-0511 by 
March 24, 2020 (see FOR

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FURTHER INFORMATION CONTACT). 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 
meeting must register by 11:59 p.m. Eastern Time on March 24, 2020. 
Early registration is recommended because seating is limited; 
therefore, FDA may limit the number of participants from each 
organization.
    If you need special accommodations due to a disability, please 
contact Jessica.Berrellez@fda.hhs.gov (see FOR FURTHER INFORMATION 
CONTACT) no later than 11:59 p.m. Eastern Time on March 20, 2020.
    Presenters and Panelists: 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. 
Presenters and panelists will discuss their scientific and/or technical 
knowledge on the questions and presentations in each session. 
Presenters and panelists will be responsible for their own travel 
arrangements.
    To be considered to serve as a presenter and/or panelist, please 
provide the following:
     Presenters: A brief abstract for each presentation. The 
abstract should identify the specific topic(s) to be addressed and the 
amount of time requested.
     Presenters and panelists: A one-page biosketch that 
describes and supports your scientific or technical expertise on the 
specific topic(s) being presented, nature of your experience and 
research in the scientific field, positions held, and any program 
development activities.
    If you are interested in serving as a presenter or a panelist, you 
must submit the above information, along with the topic(s) on which you 
would like to speak, to Jessica.Berrellez@fda.hhs.gov by January 28, 
2020.
    We will do our best to accommodate requests to make presentations 
and serve on the panel. Individuals and organizations with common 
interests are urged to consolidate or coordinate their presentations, 
and request time for a joint presentation. Following the close of 
registration, we will determine the amount of time allotted to each 
presenter and the approximate time each oral presentation is to begin, 
and will select and notify presenters and panelists by March 6, 2020. 
If selected for presentation, any presentation materials must be 
emailed to Jessica.Berrellez@fda.hhs.gov no later than 11:59 p.m. 
Eastern Time on March 20, 2020. No commercial or promotional material 
will be permitted to be presented or distributed at the public meeting.
    Streaming Webcast of the Public Meeting: This public meeting will 
also be webcast. Please register for the streaming webcast of the 
workshop via https://fdapublicmeetingmodernizingdatastrategy.eventbrite.com by 11:59 p.m. 
Eastern Time on March 24, 2020. Pre-registration for the webcast is 
recommended, but not required. The webcast will be available and active 
during the public meeting at https://collaboration.fda.gov/fdadmpm/.
    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: January 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00071 Filed 1-7-20; 8:45 am]
 BILLING CODE 4164-01-P