FDA Science Forum 2023; Public Workshop, 26569 [2023-09175]

Download as PDF Federal Register / Vol. 88, No. 83 / Monday, May 1, 2023 / Notices comment. FDA is not seeking comment on the content of Chapter 1. Chapter 2 in this document is the first new Chapter, which provides draft designs of data elements and terminologies, in some cases new and in other cases updated from Chapter 1, associated with PQ/CMC subject areas and concepts and scoped to some of what is currently submitted in Module 3 of the eCTD submission. Since the data elements and terminologies in Chapter 2 are new and/ or updated, review of Chapter 1, solely as a reference, is highly recommended. After publication of this notice with Chapter 2 of the PQ/CMC Data Elements and Terminologies document, subsequent Chapters will be posted on FDA’s PQ/CMC web page (https:// www.fda.gov/industry/fda-datastandards-advisory-board/ pharmaceutical-qualitychemistrymanufacturing-controls-pqcmc). Public comments, specifying to which Chapter the comments are submitted, can be made to the open docket. Comments may be submitted to this docket at any time, but comments should be submitted on new Chapters within 60 days of being posted on FDA’s PQ/CMC web page to ensure that the Agency considers your comment before it begins work on the final version of the Chapter. FDA will aim to provide a new Chapter of the PQ/CMC Data Elements and Terminologies periodically. FDA is targeting posting updates to this content to FDA’s PQ/CMC web page by the end of the calendar months of March, June, September, and December of each year. This update may consist of a note that there is no new content for review in this period or, alternatively, that there is new content to be reviewed for comment, along with a link to the relevant documentation, background, and instructions on submitting comments. III. Electronic Access lotter on DSK11XQN23PROD with NOTICES1 Persons with access to the internet may obtain the draft data elements and terminologies at either https:// www.fda.gov/industry/fda-datastandards-advisory-board/ pharmaceutical-qualitychemistrymanufacturing-controls-pqcmc or https://www.regulations.gov. Dated: April 26, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–09173 Filed 4–28–23; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 17:10 Apr 28, 2023 Jkt 259001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–N–1358] FDA Science Forum 2023; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ‘‘FDA Science Forum 2023.’’ The purpose of the public workshop is to inform the public about the breadth of research underway at the Agency, and to show how cutting-edge science informs FDA’s regulatory decision-making to protect and promote public health. DATES: The public workshop will be held on June 13, 2023 (Day 1), from 9 a.m. to 3:30 p.m. Eastern Time, and June 14, 2023 (Day 2), from 9 a.m. to 2 p.m. Eastern Time. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The public workshop will be held via webcast. FOR FURTHER INFORMATION CONTACT: Rokhsareh Shahidzadeh, Office of Scientific Professional Development, Office of the Chief Scientist, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 2383, Silver Spring, MD 20993, 301–796–8740, FDASciProDev@fda.hhs.gov. SUPPLEMENTARY INFORMATION: SUMMARY: I. Background The FDA Science Forum is held biennially to inform the public about the groundbreaking science conducted at the Agency, and to show how scientific research is used in FDA’s regulatory decisions to protect and promote public health. Open to the public, industry, academia, patient advocates, government agencies, and current and potential collaborators, the 2-day event offers an opportunity to hear FDA scientific experts and nationally renowned scientists speak on a range of topics associated with regulatory science. II. Topics for Discussion at the Public Workshop The theme for the 2023 FDA Science Forum, ‘‘Advancing Regulatory Science Through Innovation,’’ will highlight areas of FDA research, including: (1) improving clinical and postmarket PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 26569 evaluation, (2) tools to effectively use big data, (3) product development tools and manufacturing, and (4) medical countermeasures (MCMs), infectious disease and pathogen reduction technologies. III. Participating in the Public Workshop Registration: To register for the public workshop, please visit the following website: https://www.fda.gov/ scienceforum. Registration is free. Persons interested in attending this public workshop must register by June 12, 2023, at 5 p.m. Eastern Time. Registrants will receive confirmation when they have been accepted. If you need special accommodations due to a disability, please contact Rokhsareh Shahidzadeh (see FOR FURTHER INFORMATION CONTACT) no later than June 5, 2023, by 5 p.m. Eastern Time. Streaming Webcast of the public workshop: This public workshop will be webcast. To register, please visit the following website: https://www.fda.gov/ scienceforum. Participants interested in viewing via webcast must register by June 12, 2023, at 5 p.m. Eastern Time. Dated: April 26, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–09175 Filed 4–28–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service Tribal Self-Governance Negotiation Cooperative Agreement Program Announcement Type: New. Funding Announcement Number: HHS–2023–IHS–TSGN–0001. Assistance Listing (Catalog of Federal Domestic Assistance or CFDA) Number: 93.444. Key Dates Application Deadline Date: May 1, 2023. Earliest Anticipated Start Date: July 31, 2023. I. Funding Opportunity Description Statutory Authority The Indian Health Service (IHS) is accepting applications for cooperative agreements for the Tribal SelfGovernance Negotiation Cooperative Agreement Program. This program is authorized under the Snyder Act, 25 U.S.C. 13; the Transfer Act, 42 U.S.C. E:\FR\FM\01MYN1.SGM 01MYN1

Agencies

[Federal Register Volume 88, Number 83 (Monday, May 1, 2023)]
[Notices]
[Page 26569]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-09175]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-1358]


FDA Science Forum 2023; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the following public workshop entitled ``FDA Science Forum 
2023.'' The purpose of the public workshop is to inform the public 
about the breadth of research underway at the Agency, and to show how 
cutting-edge science informs FDA's regulatory decision-making to 
protect and promote public health.

DATES: The public workshop will be held on June 13, 2023 (Day 1), from 
9 a.m. to 3:30 p.m. Eastern Time, and June 14, 2023 (Day 2), from 9 
a.m. to 2 p.m. Eastern Time. See the SUPPLEMENTARY INFORMATION section 
for registration date and information.

ADDRESSES: The public workshop will be held via webcast.

FOR FURTHER INFORMATION CONTACT: Rokhsareh Shahidzadeh, Office of 
Scientific Professional Development, Office of the Chief Scientist, 
Office of the Commissioner, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 32, Rm. 2383, Silver Spring, MD 20993, 301-796-
8740, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    The FDA Science Forum is held biennially to inform the public about 
the groundbreaking science conducted at the Agency, and to show how 
scientific research is used in FDA's regulatory decisions to protect 
and promote public health. Open to the public, industry, academia, 
patient advocates, government agencies, and current and potential 
collaborators, the 2-day event offers an opportunity to hear FDA 
scientific experts and nationally renowned scientists speak on a range 
of topics associated with regulatory science.

II. Topics for Discussion at the Public Workshop

    The theme for the 2023 FDA Science Forum, ``Advancing Regulatory 
Science Through Innovation,'' will highlight areas of FDA research, 
including: (1) improving clinical and postmarket evaluation, (2) tools 
to effectively use big data, (3) product development tools and 
manufacturing, and (4) medical countermeasures (MCMs), infectious 
disease and pathogen reduction technologies.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit the 
following website: https://www.fda.gov/scienceforum.
    Registration is free. Persons interested in attending this public 
workshop must register by June 12, 2023, at 5 p.m. Eastern Time. 
Registrants will receive confirmation when they have been accepted.
    If you need special accommodations due to a disability, please 
contact Rokhsareh Shahidzadeh (see FOR FURTHER INFORMATION CONTACT) no 
later than June 5, 2023, by 5 p.m. Eastern Time.
    Streaming Webcast of the public workshop: This public workshop will 
be webcast. To register, please visit the following website: https://www.fda.gov/scienceforum. Participants interested in viewing via 
webcast must register by June 12, 2023, at 5 p.m. Eastern Time.

    Dated: April 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-09175 Filed 4-28-23; 8:45 am]
BILLING CODE 4164-01-P
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