GUIDE: DRAFTING COMMENTS TO REGULATORY AGENCIES
BEFORE WRITING, READING OR SUBMITTING COMMENTS:
1. Read and understand the implications of the regulatory action. 2. Know and adhere to the deadline for commenting on the action. 3. Familiarize yourself with the comment submission process.
IN YOUR WRITTEN OR ORAL COMMENTS BE SURE TO INCLUDE:
1. Your name and your connection to the cause or issue. 2. Any credentials or experiences you might have (personally or professionally) that would separate your comments from others. 3. Your position for or against the regulatory action. Be specific about how the action would either negatively or positively affect patient lives. 4. Background information (facts, statistics, etc.) with supporting documentation. 5. A clear statement or request for the action you would like to see taken.
CONSTRUCTIVE COMMENTS CAN MAKE A DIFFERENCE. TAKE THE TIME TO PROVIDE COMMENTS ON ISSUES IMPORTANT TO YOU AND OTHER PATIENTS.
ADDITIONAL CONSIDERATIONS FOR A COMMENT SUBMISSION • If presenting comments in person, know the length of time you have to read your comments. Often, the time permitted is 5 minutes, so be sure to prepare your oral comments with that in mind. • Always keep a copy of your written comments. • Track what happens to the regulatory action.
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