Administration of U.S. Fish and Wildlife Service Investigational New Animal Drug (INAD) Program

Forms and Documents

Document	Type	Status	Availability
Form ERYMICIN- (W, 1, 2 Erythromycin 200 Injectable INAD #12–781 - Government	Form and Instruction	New	Repair queued
Form ERYMICIN- (W, 1, 2 Erythromycin 200 Injectable INAD #12–781 - Private Sector	Form and Instruction	New	Repair queued
Form CALC- (W, 1, 2, 3) Calcein (Se–Mark®) INAD #10–987 - Government	Form and Instruction	New	Repair queued
Form CALC- (W, 1, 2, 3) Calcein (Se–Mark®) INAD #10–987 - Private Sector	Form and Instruction	New	Repair queued
Form CCP- (W, 1, 2, 3, Common Carp Pituitary (CCP) INAD #8391 - Government	Form and Instruction	New	Repair queued
Form CCP- (W, 1, 2, 3, Common Carp Pituitary (CCP) INAD #8391 - Private Sector	Form and Instruction	New	Repair queued
Form OVAPLANT-L- (W, 1, Ovaplant®-L Salmon Gonadotropin – Releasing Hormone analoque (sGnRHa) INAD #13–298 - Government	Form and Instruction	New	Repair queued
Form OVAPLANT-L- (W, 1, Ovaplant®-L Salmon Gonadotropin – Releasing Hormone analoque (sGnRHa) INAD #13–298 - Private Sector	Form and Instruction	New	Repair queued
Form SGNRHA/OVAPLANT- ( Ovaplant® Salmon Gonadotropin – Releasing Hormone analoque (sGnRHa) INAD #11–375 - Government	Form and Instruction	New	Repair queued
Form SGNRHA/OVAPLANT- ( Ovaplant® Salmon Gonadotropin – Releasing Hormone analoque (sGnRHa) INAD #11–375 - Private Sector	Form and Instruction	New	Repair queued
Form GnRH IIA- (W, 1, 2 GnRH IIa Chicken Gonadotropin – Releasing Hormone II analog INAD #13–345 - Government	Form and Instruction	New	Repair queued
Form GnRH IIA- (W, 1, 2 GnRH IIa Chicken Gonadotropin – Releasing Hormone II analog INAD #13–345 - Private Sector	Form and Instruction	New	Repair queued
Form LHRHA- (W, 1, 2, 3 Lutenizing Hormone – Releasing Hormone (LHRHa) INAD #8061 - Government	Form and Instruction	New	Repair queued
Form LHRHA- (W, 1, 2, 3 Lutenizing Hormone – Releasing Hormone (LHRHa) INAD #8061 - Private Sector	Form and Instruction	New	Repair queued
Form BZK- (W, 1, 2, 3) BENZOAK VET® INAD #11–740 - Government	Form and Instruction	New	Repair queued
Form BZK- (W, 1, 2, 3) BENZOAK VET® INAD #11–740 - Private Sector	Form and Instruction	New	Repair queued
Form AQSE- (W, 1, 2, 3) AQUI–S®20E INAD #11–741 - Government	Form and Instruction	New	Repair queued
Form AQSE- (W, 1, 2, 3) AQUI–S®20E INAD #11–741 - Private Sector	Form and Instruction	New	Repair queued
Form DQT- (W, 1, 2, 3) Diquat® INAD #10–969 - Government	Form and Instruction	New	Repair queued
Form DQT- (W, 1, 2, 3) Diquat® INAD #10–969 - Private Sector	Form and Instruction	New	Repair queued
Form OTIMM- (W, 1, 2, 3 Oxytetracycline hydrochloride INAD #9033 - Government	Form and Instruction	New	Repair queued
Form OTIMM- (W, 1, 2, 3 Oxytetracycline hydrochloride INAD #9033 - Private Sector	Form and Instruction	New	Repair queued
Form H202- (W, 1, 2, 3) Hydrogen peroxide (35% Perox Aid®) INAD #11–669 - Government	Form and Instruction	New	Repair queued
Form H202- (W, 1, 2, 3) Hydrogen peroxide (35% Perox Aid®) INAD #11–669 - Private Sector	Form and Instruction	New	Repair queued
Form CLT- (W, 1, 2, 3) Chloramine–T INAD #9321 - Government	Form and Instruction	New	Repair queued
Form CLT- (W, 1, 2, 3) Chloramine–T INAD #9321 - Private Sector	Form and Instruction	New	Repair queued
Form 17BE2- (W, 1, 2, 2 17β–Estradiol INAD #12–671 - Government	Form and Instruction	New	Repair queued
Form 17BE2- (W, 1, 2, 2 17β–Estradiol INAD #12–671 - Private Sector	Form and Instruction	New	Repair queued
Form MT- (W, 1 2, 2A, 3 17α–methyltestosterone INAD #8557 - Government	Form and Instruction	New	Repair queued
Form MT- (W, 1 2, 2A, 3 17α–methyltestosterone INAD #8557 - Private Sector	Form and Instruction	New	Repair queued
Form MT- (W, 1 2, 2A, 3 17α–methyltestosterone INAD #11–236 - Government	Form and Instruction	New	Repair queued
Form MT- (W, 1 2, 2A, 3 17α–methyltestosterone INAD #11–236 - Private Sector	Form and Instruction	New	Repair queued
Form OTC- (W, 1, 2A, 2B Oxytetracylcine dihydrate (Terramycin® 200 for Fish) INAD #9332 - Government	Form and Instruction	New	Repair queued
Form OTC- (W, 1, 2A, 2B Oxytetracylcine dihydrate (Terramycin® 200 for Fish) INAD #9332 - Private Sector	Form and Instruction	New	Repair queued
Form SLICE- (W, 1, 2A, Slice® (Emamectin Benzoate) INAD #11–370 - Government	Form and Instruction	New	Missing upstream
Form SLICE- (W, 1, 2A, Slice® (Emamectin Benzoate) INAD #11–370 - Private Sector	Form and Instruction	New	Repair queued
Form FFC- (W, 1, 2a, 2b Florfenicol (Aquaflor®) INAD #10–697 - Government	Form and Instruction	New	Repair queued
Form FFC- (W, 1, 2a, 2b Florfenicol (Aquaflor®) INAD #10–697 - Private Sector	Form and Instruction	New	Repair queued
1018-New SSA INAD AADAP 05182023.docx	Supporting Statement A	Uploaded 2023-05-18	Repair queued
1018-New 30-day FRN INAD 07132023 88FR44820.pdf	Supplementary Document	Uploaded 2023-07-13	Repair queued
1018-New 60-day FRN INAD 07202021 86FR38349.pdf	Supplementary Document	Uploaded 2023-05-01	Repair queued
21 CFR Part 514 as of 02092023.pdf	Supplementary Document	Uploaded 2023-05-01	Repair queued
21 CFR Part 511 as of 02092023.pdf	Supplementary Document	Uploaded 2023-05-01	Repair queued
USCODE-2021-title21-chap9-subchapV-partA-sec360b.pdf	Supplementary Document	Uploaded 2023-05-01	Repair queued

IC Document Collections

IC ID	Collection	Type	Status	Form
259418	Erythromycin 200 Injectable INAD #12–781 - Government	Form and Instruction	New
259417	Erythromycin 200 Injectable INAD #12–781 - Private Sector	Form and Instruction	New
259416	Calcein (Se–Mark®) INAD #10–987 - Government	Form and Instruction	New
259415	Calcein (Se–Mark®) INAD #10–987 - Private Sector	Form and Instruction	New
259414	Common Carp Pituitary (CCP) INAD #8391 - Government	Form and Instruction	New
259413	Common Carp Pituitary (CCP) INAD #8391 - Private Sector	Form and Instruction	New
259410	Ovaplant®-L Salmon Gonadotropin – Releasing Hormone analoque (sGnRHa) INAD #13–298 - Government	Form and Instruction	New
259409	Ovaplant®-L Salmon Gonadotropin – Releasing Hormone analoque (sGnRHa) INAD #13–298 - Private Sector	Form and Instruction	New
259408	Ovaplant® Salmon Gonadotropin – Releasing Hormone analoque (sGnRHa) INAD #11–375 - Government	Form and Instruction	New
259407	Ovaplant® Salmon Gonadotropin – Releasing Hormone analoque (sGnRHa) INAD #11–375 - Private Sector	Form and Instruction	New
259406	GnRH IIa Chicken Gonadotropin – Releasing Hormone II analog INAD #13–345 - Government	Form and Instruction	New
259405	GnRH IIa Chicken Gonadotropin – Releasing Hormone II analog INAD #13–345 - Private Sector	Form and Instruction	New
259403	Lutenizing Hormone – Releasing Hormone (LHRHa) INAD #8061 - Government	Form and Instruction	New
259402	Lutenizing Hormone – Releasing Hormone (LHRHa) INAD #8061 - Private Sector	Form and Instruction	New
259401	BENZOAK VET® INAD #11–740 - Government	Form and Instruction	New
259400	BENZOAK VET® INAD #11–740 - Private Sector	Form and Instruction	New
259399	AQUI–S®20E INAD #11–741 - Government	Form and Instruction	New
259398	AQUI–S®20E INAD #11–741 - Private Sector	Form and Instruction	New
259397	Diquat® INAD #10–969 - Government	Form and Instruction	New
259396	Diquat® INAD #10–969 - Private Sector	Form and Instruction	New
259395	Oxytetracycline hydrochloride INAD #9033 - Government	Form and Instruction	New
259394	Oxytetracycline hydrochloride INAD #9033 - Private Sector	Form and Instruction	New
259393	Hydrogen peroxide (35% Perox Aid®) INAD #11–669 - Government	Form and Instruction	New
259392	Hydrogen peroxide (35% Perox Aid®) INAD #11–669 - Private Sector	Form and Instruction	New
259391	Chloramine–T INAD #9321 - Government	Form and Instruction	New
259390	Chloramine–T INAD #9321 - Private Sector	Form and Instruction	New
259389	17β–Estradiol INAD #12–671 - Government	Form and Instruction	New
259387	17β–Estradiol INAD #12–671 - Private Sector	Form and Instruction	New
259385	17α–methyltestosterone INAD #8557 - Government	Form and Instruction	New
259384	17α–methyltestosterone INAD #8557 - Private Sector	Form and Instruction	New
259370	17α–methyltestosterone INAD #11–236 - Government	Form and Instruction	New
259369	17α–methyltestosterone INAD #11–236 - Private Sector	Form and Instruction	New
259368	Oxytetracylcine dihydrate (Terramycin® 200 for Fish) INAD #9332 - Government	Form and Instruction	New
259367	Oxytetracylcine dihydrate (Terramycin® 200 for Fish) INAD #9332 - Private Sector	Form and Instruction	New
259366	Slice® (Emamectin Benzoate) INAD #11–370 - Government	Form and Instruction	New
259365	Slice® (Emamectin Benzoate) INAD #11–370 - Private Sector	Form and Instruction	New
259364	Florfenicol (Aquaflor®) INAD #10–697 - Government	Form and Instruction	New
259363	Florfenicol (Aquaflor®) INAD #10–697 - Private Sector	Form and Instruction	New
259362	Cooperative Agreement - Government	Other-Agreement	New
259360	Cooperative Agreement - Private Sector	Other-Agreement	New

ICR Details

OMB Control No:	ICR Reference No: 202303-1018-006
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: DOI/FWS	Agency Tracking No:
Title: Administration of U.S. Fish and Wildlife Service Investigational New Animal Drug (INAD) Program
Type of Information Collection: Existing collection in use without an OMB Control Number	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 07/13/2023

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	302	0
Time Burden (Hours)	1,215	0
Cost Burden (Dollars)	289,232	0

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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).

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Authorizing Statute(s): US Code: 21 USC 360b(j) Name of Law: Federal Food, Drug, and Cosmetic Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 38349	07/20/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 44820	07/13/2023
Did the Agency receive public comments on this ICR? No

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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)	STUDY PROTOCOL FOR AN AQUACULTURE INVESTIGATIONAL NEW ANIMAL DRUG (INAD) EXEMPTION FOR THE USE OF 17-ALPHA METHYLTESTOSTERONE IN TILAPIA (INAD #11-236)
17α–methyltestosterone INAD #11–236 - Private Sector	MT- (W, 1 2, 2A, 3, 4A)	STUDY PROTOCOL FOR AN AQUACULTURE INVESTIGATIONAL NEW ANIMAL DRUG (INAD) EXEMPTION FOR THE USE OF 17-ALPHA METHYLTESTOSTERONE IN TILAPIA (INAD #11-236)
17α–methyltestosterone INAD #8557 - Government	MT- (W, 1 2, 2A, 3, 4A)	STUDY PROTOCOL FOR AN AQUACULTURE INVESTIGATIONAL NEW ANIMAL DRUG (INAD) EXEMPTION FOR THE USE OF 17-ALPHA METHYLTESTOSTERONE IN RAINBOW TROUT AND ATLANTIC SALMON (INAD #8557)
17α–methyltestosterone INAD #8557 - Private Sector	MT- (W, 1 2, 2A, 3, 4A)	STUDY PROTOCOL FOR AN AQUACULTURE INVESTIGATIONAL NEW ANIMAL DRUG (INAD) EXEMPTION FOR THE USE OF 17-ALPHA METHYLTESTOSTERONE IN RAINBOW TROUT AND ATLANTIC SALMON (INAD #8557)
17β–Estradiol INAD #12–671 - Government	17BE2- (W, 1, 2, 2A, 3, 4A)	STUDY PROTOCOL FOR AN AQUACULTURE INVESTIGATIONAL NEW ANIMAL DRUG (INAD) EXEMPTION FOR THE USE OF ESTRADIOL (17β-estradiol) IN BROOK TROUT (INAD #12-671)
17β–Estradiol INAD #12–671 - Private Sector	17BE2- (W, 1, 2, 2A, 3, 4A)	STUDY PROTOCOL FOR AN AQUACULTURE INVESTIGATIONAL NEW ANIMAL DRUG (INAD) EXEMPTION FOR THE USE OF ESTRADIOL (17β-estradiol) IN BROOK TROUT (INAD #12-671)
AQUI–S®20E INAD #11–741 - Government	AQSE- (W, 1, 2, 3)	STUDY PROTOCOL FOR A COMPASSIONATE AQUACULTURE INVESTIGATIONAL NEW ANIMAL DRUG (INAD) EXEMPTION FOR AQUI-S®20E (eugenol) (INAD #11-741)
AQUI–S®20E INAD #11–741 - Private Sector	AQSE- (W, 1, 2, 3)	STUDY PROTOCOL FOR A COMPASSIONATE AQUACULTURE INVESTIGATIONAL NEW ANIMAL DRUG (INAD) EXEMPTION FOR AQUI-S®20E (eugenol) (INAD #11-741)
BENZOAK VET® INAD #11–740 - Government	BZK- (W, 1, 2, 3)	STUDY PROTOCOL FOR A COMPASSIONATE AQUACULTURE INVESTIGATIONAL NEW ANIMAL DRUG (INAD) EXEMPTION FOR BENZOAK VET® (benzocaine) (INAD #11-740)
BENZOAK VET® INAD #11–740 - Private Sector	BZK- (W, 1, 2, 3)	STUDY PROTOCOL FOR A COMPASSIONATE AQUACULTURE INVESTIGATIONAL NEW ANIMAL DRUG (INAD) EXEMPTION FOR BENZOAK VET® (benzocaine) (INAD #11-740)
Calcein (Se–Mark®) INAD #10–987 - Government	CALC- (W, 1, 2, 3)	STUDY PROTOCOL FOR A COMPASSIONATE AQUACULTURE INVESTIGATIONAL NEW ANIMAL DRUG (INAD) EXEMPTION FOR CALCEIN (SE-MARK®) (INAD #10-987)
Calcein (Se–Mark®) INAD #10–987 - Private Sector	CALC- (W, 1, 2, 3)	STUDY PROTOCOL FOR A COMPASSIONATE AQUACULTURE INVESTIGATIONAL NEW ANIMAL DRUG (INAD) EXEMPTION FOR CALCEIN (SE-MARK®) (INAD #10-987)
Chloramine–T INAD #9321 - Government	CLT- (W, 1, 2, 3)	STUDY PROTOCOL FOR AN AQUACULTURE INVESTIGATIONAL NEW ANIMAL DRUG (INAD) EXEMPTION FOR CHLORAMINE-T (INAD #9321)
Chloramine–T INAD #9321 - Private Sector	CLT- (W, 1, 2, 3)	STUDY PROTOCOL FOR AN AQUACULTURE INVESTIGATIONAL NEW ANIMAL DRUG (INAD) EXEMPTION FOR CHLORAMINE-T (INAD #9321)
Common Carp Pituitary (CCP) INAD #8391 - Government	CCP- (W, 1, 2, 3, 4N)	STUDY PROTOCOL FOR A COMPASSIONATE AQUACULTURE INVESTIGATIONAL NEW ANIMAL DRUG (INAD) EXEMPTION FOR COMMON CARP PITUITARY (CCP) INAD 8391
Common Carp Pituitary (CCP) INAD #8391 - Private Sector	CCP- (W, 1, 2, 3, 4N)	STUDY PROTOCOL FOR A COMPASSIONATE AQUACULTURE INVESTIGATIONAL NEW ANIMAL DRUG (INAD) EXEMPTION FOR COMMON CARP PITUITARY (CCP) INAD 8391
Cooperative Agreement - Government
Cooperative Agreement - Private Sector
Diquat® INAD #10–969 - Government	DQT- (W, 1, 2, 3)	STUDY PROTOCOL FOR A COMPASSIONATE AQUACULTURE INVESTIGATIONAL NEW ANIMAL DRUG (INAD) EXEMPTION FOR REWARD® (DIQUAT DIBROMIDE) under INAD #10-969
Diquat® INAD #10–969 - Private Sector	DQT- (W, 1, 2, 3)	STUDY PROTOCOL FOR A COMPASSIONATE AQUACULTURE INVESTIGATIONAL NEW ANIMAL DRUG (INAD) EXEMPTION FOR REWARD® (DIQUAT DIBROMIDE) under INAD #10-969
Erythromycin 200 Injectable INAD #12–781 - Government	ERYMICIN- (W, 1, 2, 3)	STUDY PROTOCOL FOR A COMPASSIONATE AQUACULTURE INVESTIGATIONAL NEW ANIMAL DRUG (INAD) EXEMPTION FOR ERYTHROMYCIN (Erymicin 200 Injection) (INAD 12-781)
Erythromycin 200 Injectable INAD #12–781 - Private Sector	ERYMICIN- (W, 1, 2, 3)	STUDY PROTOCOL FOR A COMPASSIONATE AQUACULTURE INVESTIGATIONAL NEW ANIMAL DRUG (INAD) EXEMPTION FOR ERYTHROMYCIN (Erymicin 200 Injection) (INAD 12-781)
Florfenicol (Aquaflor®) INAD #10–697 - Government	FFC- (W, 1, 2a, 2b, 3)	STUDY PROTOCOL FOR AN AQUACULTURE INVESTIGATIONAL NEW ANIMAL DRUG (INAD) EXEMPTION FOR AQUAFLOR® (florfenicol) USE AS A FEED ADDITIVE (INAD #10-697)
Florfenicol (Aquaflor®) INAD #10–697 - Private Sector	FFC- (W, 1, 2a, 2b, 3)	STUDY PROTOCOL FOR AN AQUACULTURE INVESTIGATIONAL NEW ANIMAL DRUG (INAD) EXEMPTION FOR AQUAFLOR® (florfenicol) USE AS A FEED ADDITIVE (INAD #10-697)
GnRH IIa Chicken Gonadotropin – Releasing Hormone II analog INAD #13–345 - Government	GnRH IIA- (W, 1, 2, 3, 4N)	STUDY PROTOCOL FOR A COMPASSIONATE AQUACULTURE INVESTIGATIONAL NEW ANIMAL DRUG (INAD) EXEMPTION FOR CHICKEN GONADOTROPIN-RELEASING HORMONE II ANALOG (GnRH IIa) (INAD 13-345)
GnRH IIa Chicken Gonadotropin – Releasing Hormone II analog INAD #13–345 - Private Sector	GnRH IIA- (W, 1, 2, 3, 4N)	STUDY PROTOCOL FOR A COMPASSIONATE AQUACULTURE INVESTIGATIONAL NEW ANIMAL DRUG (INAD) EXEMPTION FOR CHICKEN GONADOTROPIN-RELEASING HORMONE II ANALOG (GnRH IIa) (INAD 13-345)
Hydrogen peroxide (35% Perox Aid®) INAD #11–669 - Government	H202- (W, 1, 2, 3)	STUDY PROTOCOL FOR A COMPASSIONATE AQUACULTURE INVESTIGATIONAL NEW ANIMAL DRUG (INAD) EXEMPTION FOR 35% PEROX AID® (HYDROGEN PEROXIDE) FOR THE CONTROL OF ECTOPARASITES (INAD #11-669)
Hydrogen peroxide (35% Perox Aid®) INAD #11–669 - Private Sector	H202- (W, 1, 2, 3)	STUDY PROTOCOL FOR A COMPASSIONATE AQUACULTURE INVESTIGATIONAL NEW ANIMAL DRUG (INAD) EXEMPTION FOR 35% PEROX AID® (HYDROGEN PEROXIDE) FOR THE CONTROL OF ECTOPARASITES (INAD #11-669)
Lutenizing Hormone – Releasing Hormone (LHRHa) INAD #8061 - Government	LHRHA- (W, 1, 2, 3)	STUDY PROTOCOL FOR A COMPASSIONATE AQUACULTURE INVESTIGATIONAL NEW ANIMAL DRUG (INAD) EXEMPTION FOR LUTEINIZING HORMONE-RELEASING HORMONE ANALOG des-Gly10,[D-Ala6]LH-RH Ethylamide (LHRHa Liquid/LHR
Lutenizing Hormone – Releasing Hormone (LHRHa) INAD #8061 - Private Sector	LHRHA- (W, 1, 2, 3)	STUDY PROTOCOL FOR A COMPASSIONATE AQUACULTURE INVESTIGATIONAL NEW ANIMAL DRUG (INAD) EXEMPTION FOR LUTEINIZING HORMONE-RELEASING HORMONE ANALOG des-Gly10,[D-Ala6]LH-RH Ethylamide (LHRHa Liquid/LHR
Ovaplant® Salmon Gonadotropin – Releasing Hormone analoque (sGnRHa) INAD #11–375 - Government	SGNRHA/OVAPLANT- (W, 1, 2, 3, 4N)	STUDY PROTOCOL FOR A COMPASSIONATE AQUACULTURE INVESTIGATIONAL NEW ANIMAL DRUG (INAD) EXEMPTION FOR SALMON GONADOTROPIN-RELEASING HORMONE ANALOGUE (sGnRHa - Ovaplant®) (INAD #11-375)
Ovaplant® Salmon Gonadotropin – Releasing Hormone analoque (sGnRHa) INAD #11–375 - Private Sector	SGNRHA/OVAPLANT- (W, 1, 2, 3, 4N)	STUDY PROTOCOL FOR A COMPASSIONATE AQUACULTURE INVESTIGATIONAL NEW ANIMAL DRUG (INAD) EXEMPTION FOR SALMON GONADOTROPIN-RELEASING HORMONE ANALOGUE (sGnRHa - Ovaplant®) (INAD #11-375)
Ovaplant®-L Salmon Gonadotropin – Releasing Hormone analoque (sGnRHa) INAD #13–298 - Government	OVAPLANT-L- (W, 1, 2, 3, 4N)	STUDY PROTOCOL FOR A COMPASSIONATE AQUACULTURE INVESTIGATIONAL NEW ANIMAL DRUG (INAD) EXEMPTION FOR SALMON GONADOTROPIN-RELEASING HORMONE ANALOGUE (sGnRHa – OVAPLANT-L) (INAD 13-298)
Ovaplant®-L Salmon Gonadotropin – Releasing Hormone analoque (sGnRHa) INAD #13–298 - Private Sector	OVAPLANT-L- (W, 1, 2, 3, 4N)	STUDY PROTOCOL FOR A COMPASSIONATE AQUACULTURE INVESTIGATIONAL NEW ANIMAL DRUG (INAD) EXEMPTION FOR SALMON GONADOTROPIN-RELEASING HORMONE ANALOGUE (sGnRHa – OVAPLANT-L) (INAD 13-298)
Oxytetracycline hydrochloride INAD #9033 - Government	OTIMM- (W, 1, 2, 3)	STUDY PROTOCOL FOR AN AQUACULTURE INVESTIGATIONAL NEW ANIMAL DRUG (INAD) EXEMPTION FOR OXYTETRACYCLINE (PENNOX 343®) FOR IMMERSION THERAPY (INAD #9033)
Oxytetracycline hydrochloride INAD #9033 - Private Sector	OTIMM- (W, 1, 2, 3)	STUDY PROTOCOL FOR AN AQUACULTURE INVESTIGATIONAL NEW ANIMAL DRUG (INAD) EXEMPTION FOR OXYTETRACYCLINE (PENNOX 343®) FOR IMMERSION THERAPY (INAD #9033)
Oxytetracylcine dihydrate (Terramycin® 200 for Fish) INAD #9332 - Government	OTC- (W, 1, 2A, 2B, 3A, 3B)	STUDY PROTOCOL FOR AN AQUACULTURE INVESTIGATIONAL NEW ANIMAL DRUG (INAD) EXEMPTION FOR OXYTETRACYCLINE (TERRAMYCIN® 200 for Fish) MEDICATED FEED (INAD #9332)
Oxytetracylcine dihydrate (Terramycin® 200 for Fish) INAD #9332 - Private Sector	OTC- (W, 1, 2A, 2B, 3A, 3B)	STUDY PROTOCOL FOR AN AQUACULTURE INVESTIGATIONAL NEW ANIMAL DRUG (INAD) EXEMPTION FOR OXYTETRACYCLINE (TERRAMYCIN® 200 for Fish) MEDICATED FEED (INAD #9332)
Slice® (Emamectin Benzoate) INAD #11–370 - Government	SLICE- (W, 1, 2A, 2B, 3, 3S)	STUDY PROTOCOL FOR A COMPASSIONATE AQUACULTURE INVESTIGATIONAL NEW ANIMAL DRUG (INAD) EXEMPTION FOR SLICE® (EMAMECTIN BENZOATE) (INAD #11-370)
Slice® (Emamectin Benzoate) INAD #11–370 - Private Sector	SLICE- (W, 1, 2A, 2B, 3, 3S)	STUDY PROTOCOL FOR A COMPASSIONATE AQUACULTURE INVESTIGATIONAL NEW ANIMAL DRUG (INAD) EXEMPTION FOR SLICE® (EMAMECTIN BENZOATE) (INAD #11-370)

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	302	0	0	302	0	0
Annual Time Burden (Hours)	1,215	0	0	1,215	0	0
Annual Cost Burden (Dollars)	289,232	0	0	289,232	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a request for OMB approval of a new information collection in use without a control number.

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Annual Cost to Federal Government: $339,812

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 07/13/2023

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