Notice of Claimed

Figure 7.1 Information supplied to the CVM in support of a Notice of Claimed Investigational Exemption (NCIE) for an Investigational New Animal Drug (INAD).

Once a drug is judged ready to be studied in humans, a Notice of Claimed Investigational Exemption for a New... 

In the United States, the federal FD C Act and its amendments require that a manufacturer demonstrate the safety and efficacy of a new drug prior to introducing it into interstate commerce. The requirements are clearly spelled out in the Notice of Claimed Investigational Exemption for a New Drug (IND) and the NDA. 

Final Order Failure to comply with final agency order. Automatic reinstatement of any penalty previously reduced or held in abeyance and restoration of the full amount assessed in the Notice of Claim less any payments previously made. 

Notice of Claim, penalty, and settlement agreements are the FMCSA s processes for fining a carrier and can be initiated after any of the investigative interventions. 

Once the fine, or claim, has been calculated, the carrier will receive a Notice of Claim (NOC). The NOC will detail the charges and related fines against the carrier. The NOC usually does not include all violations discovered during the audit and recorded on the audit report. It will only include the violations that the FMCSA is looking at fining the carrier over. 

Drivers that do not comply with the regulations or are involved in a disproportionate number of accidents (when compared to their peers) may find themselves subjected to attention from the FMCSA. This attention can come in the form of a Notice of Violation (a very serious warning letter) or a Notice of Claim (a fine). 

The purpose of the Notice of Claim is to deter severe or persistent unsafe behavior. It is issued as a formal document and served on the violator to compel compliance. The Notice of Claim would be triggered by evidence of a severe regulatory violation or history of violations, sufficient to justify assessment of penalties. This document initiates the issuance of a fine to a carrier. The following is a sample Notice of Claim letter. 

As a result of this review, violations were discovered. This letter constitutes a Notice of Claim by die United States Department of Transportation. Federal Motor Carrier Safety Administration (FMCSA) against Carrier A for the amount of 2,360. 

A Notice of Claim is the official charging document used by the Federal Motor Carrier Safety Admmistration to ini violations of Federal Laws ... 

Violations of either safety or hazardous materials regulations discovered during the course of the Safety compliance review, but not proposed for penalty in this Notice of Claim, may have increased the civil penalty claimed for the violations charged in this Notice of Claim. The violations found in Table 1, as attached to this Notice of Claim, detail the violations discovered during our review/inspection. 

Under 49 CFR Part 386, "Rules of Practice for Motor Carrier, Broker, Freight Forwarder, and Hazardous Materials Proceedings," you have specific rights with respect to this Notice of Claim. 

You are advised to carefully read Part 386 and follow the course of action appropriate for you in this case. A copy of Part 386 is attached to this Notice of Claim for your information. You may wish to seek legal counsel for answers to any questions in reference to this Notice of Oaim or procedures under Part 386. DO NOT call the FMCSA Service Center or the Chief Counsel s office for advice or assistance in your defense. You may pursue the following courses of action ... 

PAYMENT OF PENALTY Within 30 days of service of this Notice of Claim (a) Pay the assessed penalty in full, or (b) Establish a monthly payment plan by contacting an Enforcement Specialist (NOTE A payment plan may be available for respondents who demonstrate financial difficulty), or (c) Contact an Enforcement Specialist outlining in writing compelling reasons why the assessed penalty should he reduced and discuss potential settlement. You may he required to submit a current, certified balance sheet or other evidence of assets and liabilities. An Enforcement Specialist can he reached at (708) 283-3577. If you pay the full penalty within thirty (30) days of service of this Notice of Claim, you do not need to file a written Reply to the Notice of Claim... 

Y ou must serve your reply on all persons listed in the Certificate of Service attached to this Notice of Claim and in accordance with the requirements of 49 CFR 386.6. 

THE SPECIFIC RIGHTS PROVIDED FOR IN 49 CFR 386.14 MAY BE WAIVED IF YOU FAIL TO SUBMIT A WRITIEN REPLY WITHIN THIRTY (30) DAYS AFTER THE SERVICE OF THIS NOTICE OF CLAIM. 

FAILURE TO REPLY TO THE NOTICE OF CLAIM IN THE EXACT MANNER SPECIFIED IN 49 CFR 386.14 MAY BE TREATED AS IF NO REPLY HAS BEEN HLED. UNDER 49 CFR ... 

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