[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.

[[Page 23833]]


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, 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 
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

[[Page 23834]]

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 Jessica.Berrellez@fda.hhs.gov (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]
BILLING CODE 4164-01-P


