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Johns Hopkins Center of Excellence in Regulatory Science and Innovation

Award Number: U01FD005942
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Johns Hopkins Center of Excellence in Regulatory Science and Innovation - PROJECT SUMMARY/ABSTRACT As the world’s leading regulatory authority, and the country’s largest research university, the U.S. Food and Drug Administration and Johns Hopkins University are ideally suited to broaden and deepen their highly productive partnership through the Johns Hopkins Center of Excellence in Regulatory Science and Innovation (JH-CERSI). This program, launched in 2014, has produced fundamental and applied new knowledge impacting a breadth of regulated products, ranging from COVID-19 therapeutics (Center for Drug Evaluation and Research) to eCigarettes (Center for Tobacco Products) to upper extremity prostheses (Center for Devices and Radiologic Health). The program has also undertaken vitally important inquiries relevant to many understudied groups, including pregnant women, racial and ethnic minorities, children and individuals with opioid use disorder. This knowledge has been used by the FDA to support rule-making, guidance-development, and the alignment of strategic priorities, helping to ensure that the FDA remains a global leader in advancing the technical and scientific foundations of product regulation. Since its inception, JH-CERSI has also leveraged the historically close relationship between the FDA and Johns Hopkins, and our renewal builds upon the substantial infrastructure developed together over the past eight years. JH-CERSI’s successes reflect many strengths including remarkable commitment from the FDA’s Office of the Chief Scientist and Office of Regulatory Science and Innovation, the University’s internationally renowned scholarship in regulatory science, an immense training platform, close geographic proximity to the FDA, and a nimble and organic operational approach. In this renewal, we propose to capitalize on these strengths and on the numerous structural improvements we have made since inception. We also propose three new programmatic elements to amplify impact. First, we will appoint an Associate Director of Artificial Intelligence and an Associate Director of Data Science and Informatics to expand the depth and breadth of our activities across faculty, programs, centers and schools, including the world- renowned Whiting School of Engineering and the Johns Hopkins Applied Physics Lab. Second, we will develop new training, including in Preparedness and Public Health Communications, to address the major threat that misinformation poses to the FDA’s regulatory success. We also propose new interchange with leading overseas regulators, thereby enhancing global regulatory science. Finally, we will institute an External Partnerships Initiative to serve as a force-multiplier by leveraging the remarkable scientific networks of Johns Hopkins faculty in service of the FDA’s mission. Together, through these efforts, Johns Hopkins and the FDA will continue to achieve remarkable gains that allow the FDA to maximize its effectiveness and impact through state-of-the-art regulation in the 21st Century.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = -$1,150,806 )
2025	2024	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	004	9	4/24/2025	SUPPLEMENT FOR EXPANSION	$0
2025	2023	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	003	8	1/13/2025	COMPETING CONTINUATION	$0
2025	2023	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	002	7	1/8/2025	SUPPLEMENT FOR EXPANSION	-$331,000
2025	2022	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	001	6	1/8/2025	SUPPLEMENT FOR EXPANSION	-$331,000
2025	2022	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	000	7	1/8/2025	NON-COMPETING CONTINUATION	-$488,806
														Subtotal = -$1,150,806

Issue Date FY: 2024 ( Subtotal = $2,685,374 )
2024	2024	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	014	9	9/19/2024	SUPPLEMENT FOR EXPANSION	$259,411
2024	2024	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	020	9	9/25/2024	SUPPLEMENT FOR EXPANSION	-$303,001
2024	2024	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	023	9	9/28/2024	SUPPLEMENT FOR EXPANSION	$100,000
2024	2024	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	008	8	6/10/2024	SUPPLEMENT FOR EXPANSION	$499,999
2024	2024	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	018	9	9/22/2024	SUPPLEMENT FOR EXPANSION	$786,317
2024	2024	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	010	8	6/18/2024	SUPPLEMENT FOR EXPANSION	$94,985
2024	2024	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	009	8	6/17/2024	SUPPLEMENT FOR EXPANSION	-$499,999
2024	2024	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	017	9	9/21/2024	SUPPLEMENT FOR EXPANSION	$432,530
2024	2024	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	016	9	9/20/2024	SUPPLEMENT FOR EXPANSION	$260,375
2024	2024	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	015	9	9/19/2024	SUPPLEMENT FOR EXPANSION	$303,001
2024	2024	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	013	9	9/18/2024	SUPPLEMENT FOR EXPANSION	$171,941
2024	2024	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	019	9	9/24/2024	SUPPLEMENT FOR EXPANSION	$0
2024	2024	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	022	9	9/27/2024	SUPPLEMENT FOR EXPANSION	-$100,000
2024	2024	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	012	9	8/30/2024	NON-COMPETING CONTINUATION	$250,000
2024	2024	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	003	8	2/26/2024	SUPPLEMENT FOR EXPANSION	$300,000
2024	2024	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	021	9	9/26/2024	SUPPLEMENT FOR EXPANSION	$303,001
2024	2023	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	006	8	4/12/2024	COMPETING CONTINUATION	$1,150,807
2024	2023	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	000	8	10/22/2023	COMPETING CONTINUATION	$0
2024	2023	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	005	7	4/12/2024	SUPPLEMENT FOR EXPANSION	-$331,000
2024	2023	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	007	8	5/21/2024	COMPETING CONTINUATION	-$15,085
2024	2023	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	002	8	1/17/2024	COMPETING CONTINUATION	$0
2024	2023	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	011	8	7/19/2024	COMPETING CONTINUATION	$0
2024	2022	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	004	7	4/12/2024	NON-COMPETING CONTINUATION	-$819,807
2024	2020	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	001	4	12/13/2023	SUPPLEMENT FOR EXPANSION	-$158,101
														Subtotal = $2,685,374

Issue Date FY: 2023 ( Subtotal = $860,848 )
2023	2023	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	004	8	9/8/2023	COMPETING CONTINUATION	$229,848
2023	2023	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	003	8	5/24/2023	COMPETING CONTINUATION	$300,000
2023	2023	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	001	7	3/8/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2023	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	000	7	11/28/2022	SUPPLEMENT FOR EXPANSION	$331,000
2023	2022	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	002	7	5/10/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $860,848

Issue Date FY: 2022 ( Subtotal = $2,384,918 )
2022	2022	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	001	6	12/29/2021	SUPPLEMENT FOR EXPANSION	$207,628
2022	2022	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	004	7	8/19/2022	NON-COMPETING CONTINUATION	$1,758,155
2022	2022	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	000	6	12/22/2021	SUPPLEMENT FOR EXPANSION	$331,000
2022	2022	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	005	7	8/24/2022	NON-COMPETING CONTINUATION	$88,135
2022	2021	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	003	6	4/19/2022	NON-COMPETING CONTINUATION	$0
2022	2021	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	002	6	2/25/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $2,384,918

Issue Date FY: 2021 ( Subtotal = $1,959,574 ) (Continued on the next page)
2021	2021	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	006	6	8/31/2021	NON-COMPETING CONTINUATION	$200,000
2021	2021	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	005	6	8/10/2021	NON-COMPETING CONTINUATION	$67,130
2021	2021	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	003	5	6/21/2021	SUPPLEMENT FOR EXPANSION	$207,628
2021	2021	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	008	6	9/16/2021	NON-COMPETING CONTINUATION	$173,938
2021	2021	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	007	6	9/2/2021	NON-COMPETING CONTINUATION	$599,681
Grand Total All Awards = $15,074,377

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Johns Hopkins Center of Excellence in Regulatory Science and Innovation

Award Number: U01FD005942

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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