Comment on FR Doc # 2012-02493

Regarding the proposed Medical Device Excise tax, I have a difficult time regarding how it applies to a device firm such as my firm who performs contract manufacturing for another company and distributes it on behalf of that other company to the end user (hospital, doctor, etc.). In our case, we maintain records of distribution and are registered with the FDA as distributor, but are not involved in the sale to the end user and have no records of sales price. In this case, we invoice the other company for our manufacturing price upon completion of a manufactured lot that is significantly lower than the price to the end user. We also charge the other company a fee for the warehousing and distribution services. In the case of one of the devices we distribute, the FDA requires 4 separate entities to register as the distributor since each plays a role in the distribution and include my firm (ships product to end user), the other company (specification developer, markets, takes orders for device), importer (imports finished component of kit) and a separate company (manages complaints, returns and training). Based on my interpretation, the company that is responsible for the excise tax on this medical device would be the company making the final sale to the end user.