Monday, October 2, 2023 10/2/2023

Johns Hopkins Center of Excellence in Regulatory Science and Innovation (JH-CERSI)

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

Group Awards By Issue Date FY or Funding FY:

View Award Abstract

ABSTRACT The U.S. Food and Drug Administration's Centers of Excellence in Regulatory Science and Innovation provide institutions with a valued opportunity to work directly with regulators while simultaneously providing the FDA opportunities for access and exposure to advanced scientific exchange and training focused on the FDA's priority areas. As one of the world's leading institutions in higher education, Johns Hopkins University is pleased to collaborate with the FDA in the development of fundamental new knowledge and tools to advance regulatory science. Our proposal builds upon a historic alliance between these two vital organizations, including decades of exchange and partnership in the pursuit of scientific advancement and state-of-the-art regulation. During the past year alone, our CERSI has engaged in nearly a dozen original scientific investigations, focusing upon vital areas of regulation ranging from the role of flavorants in noncombustible tobacco products (Center for Tobacco Products) to the use of patient preference methods to design upper limb prostheses (Center for Devices and Radiologic Health). The JH-CERSI's investigations, conducted in close partnership with FDA scientists with stewardship from the Office of Regulatory Science and Innovation, have advanced the Agency's mission by strengthening the science underpinning its regulatory activities. Furthermore, these scholarly activities have been conducted while leveraging a variety of additional governmental and non-profit funding sources, providing the FDA with opportunities to considerably accelerate and amplify the investments made in the CERSI. Our CERSI also continues to support the training and professional development of the next generation of leaders in regulation through courses, workshops, seminars, competitions and certificate, master and doctoral degree programs. In the currently proposed award, we present more than two dozen scientific investigations focused on: (1) high priority topic areas, including tobacco, reducing health care associated infections, and addressing opioid use, misuse and dependence; (2) developing and evaluating new methods to improve the quality and safety of FDA-regulated products; and (3) creating methods and tools to improve quality and efficiency of clinical and post-approval evaluation of regulated products. Together, Johns Hopkins University and the U.S. Food and Drug Administration can continue to ensure that regulatory science flourishes, and in so doing, that the FDA continues to fulfill its primary charge - to safeguard the health and well-being of the public through the application of scientifically sound regulatory activities.


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: 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	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	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	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


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	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	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	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
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


Issue Date FY: 2021 ( Subtotal = $1,959,574 )
2021	2021	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	002	5	5/5/2021	SUPPLEMENT FOR EXPANSION	$21,425
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	004	6	7/23/2021	NON-COMPETING CONTINUATION	$689,772
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	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	007	6	9/2/2021	NON-COMPETING CONTINUATION	$599,681
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	2020	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	000	5	2/22/2021	NON-COMPETING CONTINUATION	$0
2021	2017	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	001	2	3/25/2021	NON-COMPETING CONTINUATION	$0


Issue Date FY: 2020 ( Subtotal = $2,984,391 )
2020	2020	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	006	5	9/29/2020	NON-COMPETING CONTINUATION	$45,952
2020	2020	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	005	5	9/11/2020	NON-COMPETING CONTINUATION	$97,114
2020	2020	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	007	5	9/30/2020	NON-COMPETING CONTINUATION	$145,994
2020	2020	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	002	4	5/7/2020	SUPPLEMENT FOR EXPANSION	$1,620,232
2020	2020	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	004	5	9/9/2020	NON-COMPETING CONTINUATION	$25,099
2020	2020	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	003	5	7/24/2020	NON-COMPETING CONTINUATION	$1,050,000
2020	2019	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	000	4	2/24/2020	NON-COMPETING CONTINUATION	$0
2020	2019	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	001	4	3/11/2020	NON-COMPETING CONTINUATION	$0


Issue Date FY: 2019 ( Subtotal = $1,534,217 )
2019	2019	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	006	4	9/10/2019	NON-COMPETING CONTINUATION	$30,000
2019	2019	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	004	4	7/11/2019	NON-COMPETING CONTINUATION	$150,000
2019	2019	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	005	4	8/27/2019	NON-COMPETING CONTINUATION	$520,511
2019	2019	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	003	3	6/17/2019	SUPPLEMENT FOR EXPANSION	$442,369
2019	2019	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	007	4	9/26/2019	NON-COMPETING CONTINUATION	$391,337
2019	2018	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	002	3	3/27/2019	COMPETING CONTINUATION	$0
2019	2018	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	001	3	11/23/2018	COMPETING CONTINUATION	$0
2019	2018	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	000	3	10/22/2018	COMPETING CONTINUATION	$0


Issue Date FY: 2018 ( Subtotal = $2,375,885 ) (Continued on the next page)
2018	2018	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	004	2	6/13/2018	SUPPLEMENT FOR EXPANSION	$154,522
2018	2018	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	007	3	8/15/2018	COMPETING CONTINUATION	$588,901
2018	2018	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	008	3	8/31/2018	COMPETING CONTINUATION	$100,000
2018	2018	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	006	3	8/9/2018	COMPETING CONTINUATION	$350,000
2018	2018	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	002	2	6/1/2018	SUPPLEMENT FOR EXPANSION	$75,178
2018	2018	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	003	2	6/5/2018	SUPPLEMENT FOR EXPANSION	$23,587
2018	2018	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	009	3	9/10/2018	COMPETING CONTINUATION	$1,083,697
2018	2017	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Food and Drug Administration Research	005	2	7/20/2018	NON-COMPETING CONTINUATION	$0
Grand Total All Awards = $13,539,809

Sum of Action Amount is $13,539,809;

Grand Total = $13,539,809

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Johns Hopkins Center of Excellence in Regulatory Science and Innovation (JH-CERSI)

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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