Joseph Henry Shepherd - Comment

I am writing to you in lieu of Docket No. FDA-2010-N-0534. After review of this docket, I have concluded that this reform is needed in order to mitigate confusion with current regulations and to update information to be more accurate with the FDA mission in regards to new animal drugs for both minor use and minor species. This would clarify the incentives needed to make more drugs legally available to both veterinarians and owners of animals and give them the freedom to address treatments for minor animal species and uncommon diseases found in major species. By passing this proposal, it would allow for profitability gains for pharmaceutical companies and relieve tension on the grey areas of the already implemented regulations to ensure there is less confusion when reviewing drug names and which categories they are under. The proposal would again, open up more room for veterinarians and animal owners to gain access to more resources to deal with these animal illness situations. In terms of legal authority, it is stated that the FDA has the rule making authority to issue any regulation that aids in the enforcement of the current FD&C Act. This proposal also poses no vast impact on the human environment and therefore alleviates the need for an environmental assessment plan. This proposal also does not create additional costs for animal drug sponsors and would not pose a deep economic impact to these small entities. In relation to federalism, this proposal would pose no threat or conflict with states in the balance of power. This would alleviate any need for a federalism summary report. The proposal provides clarification needed to allow for the proper enforcement of the FD&C Act, and does not propose more problems than solutions. For these reasons, this proposal should be allowed for.