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Convener and organizer of activities and engagements focused on the development of medical products and related processes, surveillance, and policies relevant to ongoing public health activities

Award Number: U01FD006807
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:

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PROJECT SUMMARY The Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration’s (FDA) is seeking proposals for collaborative research and convening activities advance regulatory science, policy, and procedures to address a range of critical public health topics, including drug development, drug approval, bioresearch monitoring, human subject protection, and post market surveillance. Building on over ten years of collaborative experience working with the FDA on such topics, the Duke-Robert J. Margolis, MD, Center for Health Policy (Duke-Margolis) proposes to continue collaborating with CDER to tackle a range of priority public health issues. Through this new cooperative agreement Duke-Margolis proposes to expand on our existing collaboration with FDA by partnering with CDER and experts within the Duke ecosystem to advance the following aims: Specific Aim 1: Implement a multidisciplinary and collaborative research and convening capacity to support FDA and its stakeholders to explore and address a range of critical public health topics related to FDA’s oversight of medical products, policy, and surveillance methods and systems. Our approach will incorporate a wide array of stakeholder perspectives, facilitate the identification of practical and actionable solutions, and support the public health mission of FDA. Specific Aim 2: Synthesize and distill the core research, stakeholder input, and workshop or meeting discussions pursued in Aim 1 to establish concrete, actionable next steps and recommendations for all stakeholder groups, not just FDA, to pursue. Specific Aim 3: Disseminate the findings and recommendations developed under Aim 2 to the public in a transparent and timely method, with an eye toward continually engaging stakeholders to further refine and implement key concepts and recommendations where feasible and appropriate.


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 = $618,066 )
2023	2023	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Food and Drug Administration Research	000	5	8/23/2023	NON-COMPETING CONTINUATION	$400,000
2023	2023	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Food and Drug Administration Research	001	5	9/20/2023	SUPPLEMENT FOR EXPANSION	$218,066
														Subtotal = $618,066

Issue Date FY: 2022 ( Subtotal = $726,217 )
2022	2022	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Food and Drug Administration Research	002	4	8/10/2022	NON-COMPETING CONTINUATION	$477,000
2022	2022	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Food and Drug Administration Research	000	3	6/13/2022	SUPPLEMENT FOR EXPANSION	$249,217
2022	2022	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Food and Drug Administration Research	001	3	7/15/2022	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $726,217

Issue Date FY: 2021 ( Subtotal = $698,806 )
2021	2021	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Food and Drug Administration Research	001	2	6/9/2021	SUPPLEMENT FOR EXPANSION	$248,806
2021	2021	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Food and Drug Administration Research	003	3	8/12/2021	NON-COMPETING CONTINUATION	$450,000
2021	2020	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Food and Drug Administration Research	000	2	4/13/2021	NON-COMPETING CONTINUATION	$0
2021	2020	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Food and Drug Administration Research	002	2	7/16/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $698,806

Issue Date FY: 2020 ( Subtotal = $700,000 )
2020	2020	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Food and Drug Administration Research	002	1	2/19/2020	SUPPLEMENT FOR EXPANSION	$250,000
2020	2020	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Food and Drug Administration Research	003	2	8/18/2020	NON-COMPETING CONTINUATION	$450,000
2020	2019	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Food and Drug Administration Research	001	1	1/14/2020	NEW	$0
2020	2019	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Food and Drug Administration Research	000	1	11/29/2019	NEW	$0
														Subtotal = $700,000

Issue Date FY: 2019 ( Subtotal = $450,000 )
2019	2019	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Food and Drug Administration Research	001	1	9/10/2019	NEW	-$237,875
2019	2019	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Food and Drug Administration Research	002	1	9/26/2019	NEW	$0
2019	2019	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Food and Drug Administration Research	000	1	8/20/2019	NEW	$687,875
														Subtotal = $450,000

Grand Total All Awards = $3,193,089

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Convener and organizer of activities and engagements focused on the development of medical products and related processes, surveillance, and policies relevant to ongoing public health activities

Award Number: U01FD006807

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

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

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