Form Otm 1 PDF Details

The journey of ensuring safety and efficacy of investigational new drugs for poikilothermic food animals, such as fish, is paved with rigorous documentation and oversight—a process in which the OTM-1 form plays a crucial role. Upon the receipt of a shipment containing oxytetracycline, a drug used for marking fish for fisheries management, investigators are required to promptly fill out the OTM-1 form. This form is a critical first step in a series of regulatory requirements aimed at monitoring the use of investigational new animal drugs. It mandates that the investigator keep the original document on file, and then, a copy must be sent to the Study Monitor for review. Within a short 10-day window, the Study Monitor is also tasked with forwarding a copy to the Bozeman National Inspection Office (NIO). Importantly, both the investigator and the Study Monitor must sign and date the form, affirming the accuracy of the information provided including details about the drug received such as the amount, lot number, and the intended use within the study. The form encompasses not just the logistical aspects of receiving the drug, but also outlines the proposed use, detailing the species of animals involved, the study protocol, and ensuring compliance with Federal regulations under the Federal Food, Drug, and Cosmetics Act. This detailed approach reflects the commitment to transparency, accountability, and the overarching goal of protecting the health and welfare of animal populations under investigation.

QuestionAnswer
Form NameForm Otm 1
Form Length1 pages
Fillable?No
Fillable fields0
Avg. time to fill out15 sec
Other namesOTM FORM 1 fillable receipt email in otm form

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FORM OTM-1. Report on Receipt of Drug - Guide for Reporting Investigational New Animal Drug Shipments for Poikilothermic Food Animals

INSTRUCTIONS

1.Investigator must fill out Form OTM-1 immediately upon receipt of oxytetracycline.

2.Investigator should keep the original on file, and send one copy to the Study Monitor for review.

3.Within 10 days of receipt, the Study Monitor should send a copy to the Bozeman NIO.

4.Note: Both Investigator and Study Monitor should sign and date Form OTM-1.

The sponsor, U.S. Fish and Wildlife Service, submits a notice of claimed investigational exemption for the shipment or delivery of a new animal drug under the provisions of Section 512 of the Federal Food, Drug, and Cosmetics Act. The following information is submitted in triplicate:

Name of Drug

Pennox 343

INAD Number

 

9033

 

Proposed Use of Drug

To apply a mark in a variety of fish species for use as a fishery

 

 

 

 

 

management tool.

 

 

Date of CVM Authorization Letter

 

 

April 23, 2010

 

 

Date of Drug Receipt

 

 

Amount of Drug Received

 

 

 

 

 

 

 

 

 

 

 

 

Drug Lot Number

 

 

Study Worksheet Number

 

 

 

 

 

 

 

 

 

 

 

 

Name of Investigator

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Address of Investigator

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Location of Trial

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Pivotal Study (yes/no)

 

 

Non-pivotal Study (yes/no)

 

 

 

Approximate Number of Treated

 

 

Approximate Number of

 

 

 

Animals

 

 

Control Animals

 

 

 

Number of Animals Used Previously1

 

 

 

 

 

 

 

Study Protocol Number

 

 

9033

 

 

 

Approximate dates of trial (start/end)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Species, Size, and Type of Animals

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Maximum daily dose and duration

 

 

200-700 mg/L for 2-6 hours

 

 

Methods(s) of Administration

 

Immersion (single static bath treatment)

 

 

Withdrawal Period

 

 

 

zero days

 

 

1 To be filled out by the NIO

 

 

 

 

 

 

 

Date Prepared:

 

Investigator:

 

 

 

 

 

 

 

 

 

Date Reviewed:

 

Study Monitor:

 

 

 

 

 

 

 

 

 

 

 

Date Reviewed:

 

Sponsor:

 

 

 

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Step number 1 for submitting Form Otm 1

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Step number 2 in filling out Form Otm 1

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