Certificate of waiver

A laboratory performing only waived tests must register with Health Care Finance Administration (HCFA) and obtain a certificate of waiver. However, laboratories operating under a certificate of waiver are only required to permit inspections and follow manufacturers instructions... 

Proof of medical qualifications (non-CDL holders). A current, valid medical examiner s certificate, and waiver if applicable. 

IN GENERAL—The Secretary may grant a waiver of the certification requirement of subsection (c) with respect to a noncertified poison control center or a newly established center that applies for a grant under this section if such center can reasonably demonstrate that the center will obtain such a certification within a reasonable period of time as determined appropriate by the Secretary. 

For the US, Module 1 should contain the index for the entire submission, Form FDA 356h, annotated package insert and other labeling, patent information, patent certification, debarment certification, field copy certification, user fee cover sheet, and financial disclosure information. Information on United States patents related to the drug or drug product is to be included in Module 1 of the NDA. If there were waivers for bioquivalency studies or the environmental assessment, these would go in Module 1, since they would refer to specific US regulations. An environmental assessment would be part of... 

Implement an effective process for monitoring and docrunenting all drivers job fiinctions, training, qualifications, renewal dates, disclosed medical conditions, and operational restrictions, including those of drivers on a waiver program or with impairments that may be satisfied by a Skill Performance Evaluation certificate, to ensure that assignments are covered by qualified drivers. 

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