2020-09045. 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.

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.

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, [e-mail].

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 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 [e-mail] (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.