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Abstract: The Aquatic Animal Drug Approval Partnership (AADAP) Program is part of the Fish and Aquatic Conservation fish health network, operating under the authority of the Federal Food, Drug, and Cosmetic Act (FDCA; 21 U.S.C. 360b(j)) which permits the use of an investigational new animal drug to generate data to support a NADA approval, is part of the Fish and Aquatic Conservation fish health network. It is the only program in the United States singularly dedicated to obtaining U. S. Food and Drug Administration (FDA) approval of new medications needed for use in fish culture and fisheries management. Ultimately, the AADAP program allows fisheries professionals to more effectively and efficiently rear and manage a variety of fish species to meet production goals, stock healthy fish, and maintain a healthy environment. In order for participants (U.S. aquaculture facilities or researchers) to be able to use an unapproved drug under AADAP’s National Investigational New Animal Drug (INAD) Program, they need to follow the FDA-approved study protocol(s) and submit the required data forms, including the INAD treatment data, to AADAP’s INAD Program. Data collection is required by the FDA under the following regulations: • 21 CFR part 511 (New Animal Drugs for Investigational Use) and • 21 CFR part 514, Subpart A (514.1 - 514.15, New Animal Drug Applications, General Provisions).

Number of Information Collection (IC) in this ICR: 40

IC Title	Form No.	Form Name
17α–methyltestosterone INAD #11–236 - Government	MT- (W, 1 2, 2A, 3, 4A)
17α–methyltestosterone INAD #11–236 - Private Sector	MT- (W, 1 2, 2A, 3, 4A)
17α–methyltestosterone INAD #8557 - Government	MT- (W, 1 2, 2A, 3, 4A)
17α–methyltestosterone INAD #8557 - Private Sector	MT- (W, 1 2, 2A, 3, 4A)
17β–Estradiol INAD #12–671 - Government	17BE2- (W, 1, 2, 2A, 3, 4A)
17β–Estradiol INAD #12–671 - Private Sector	17BE2- (W, 1, 2, 2A, 3, 4A)
AQUI–S®20E INAD #11–741 - Government	AQSE- (W, 1, 2, 3)
AQUI–S®20E INAD #11–741 - Private Sector	AQSE- (W, 1, 2, 3)
BENZOAK VET® INAD #11–740 - Government	BZK- (W, 1, 2, 3)
BENZOAK VET® INAD #11–740 - Private Sector	BZK- (W, 1, 2, 3)
Calcein (Se–Mark®) INAD #10–987 - Government	CALC- (W, 1, 2, 3)
Calcein (Se–Mark®) INAD #10–987 - Private Sector	CALC- (W, 1, 2, 3)
Chloramine–T INAD #9321 - Government	CLT- (W, 1, 2, 3)
Chloramine–T INAD #9321 - Private Sector	CLT- (W, 1, 2, 3)
Common Carp Pituitary (CCP) INAD #8391 - Government	CCP- (W, 1, 2, 3, 4N)
Common Carp Pituitary (CCP) INAD #8391 - Private Sector	CCP- (W, 1, 2, 3, 4N)
Cooperative Agreement - Government
Cooperative Agreement - Private Sector
Diquat® INAD #10–969 - Government	DQT- (W, 1, 2, 3)
Diquat® INAD #10–969 - Private Sector	DQT- (W, 1, 2, 3)
Erythromycin 200 Injectable INAD #12–781 - Government	ERYMICIN- (W, 1, 2, 3)
Erythromycin 200 Injectable INAD #12–781 - Private Sector	ERYMICIN- (W, 1, 2, 3)
Florfenicol (Aquaflor®) INAD #10–697 - Government	FFC- (W, 1, 2a, 2b, 3)
Florfenicol (Aquaflor®) INAD #10–697 - Private Sector	FFC- (W, 1, 2a, 2b, 3)
GnRH IIa Chicken Gonadotropin – Releasing Hormone II analog INAD #13–345 - Government	GnRH IIA- (W, 1, 2, 3, 4N)
GnRH IIa Chicken Gonadotropin – Releasing Hormone II analog INAD #13–345 - Private Sector	GnRH IIA- (W, 1, 2, 3, 4N)
Hydrogen peroxide (35% Perox Aid®) INAD #11–669 - Government	H202- (W, 1, 2, 3)
Hydrogen peroxide (35% Perox Aid®) INAD #11–669 - Private Sector	H202- (W, 1, 2, 3)
Lutenizing Hormone – Releasing Hormone (LHRHa) INAD #8061 - Government	LHRHA- (W, 1, 2, 3)
Lutenizing Hormone – Releasing Hormone (LHRHa) INAD #8061 - Private Sector	LHRHA- (W, 1, 2, 3)
Ovaplant® Salmon Gonadotropin – Releasing Hormone analoque (sGnRHa) INAD #11–375 - Government	SGNRHA/OVAPLANT- (W, 1, 2, 3, 4N)
Ovaplant® Salmon Gonadotropin – Releasing Hormone analoque (sGnRHa) INAD #11–375 - Private Sector	SGNRHA/OVAPLANT- (W, 1, 2, 3, 4N)
Ovaplant®-L Salmon Gonadotropin – Releasing Hormone analoque (sGnRHa) INAD #13–298 - Government	OVAPLANT-L- (W, 1, 2, 3, 4N)
Ovaplant®-L Salmon Gonadotropin – Releasing Hormone analoque (sGnRHa) INAD #13–298 - Private Sector	OVAPLANT-L- (W, 1, 2, 3, 4N)
Oxytetracycline hydrochloride INAD #9033 - Government	OTIMM- (W, 1, 2, 3)
Oxytetracycline hydrochloride INAD #9033 - Private Sector	OTIMM- (W, 1, 2, 3)
Oxytetracylcine dihydrate (Terramycin® 200 for Fish) INAD #9332 - Government	OTC- (W, 1, 2A, 2B, 3A, 3B)
Oxytetracylcine dihydrate (Terramycin® 200 for Fish) INAD #9332 - Private Sector	OTC- (W, 1, 2A, 2B, 3A, 3B)
Slice® (Emamectin Benzoate) INAD #11–370 - Government	SLICE- (W, 1, 2A, 2B, 3, 3S)
Slice® (Emamectin Benzoate) INAD #11–370 - Private Sector	SLICE- (W, 1, 2A, 2B, 3, 3S)

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