Instructions

Instructions for giving comments on FDA Guidance Documents

Using the Comment Portal Instructions

If you cannot access the forms inform a BAC Chair, please.
Here are some instructions when filling Google Forms:

• Read the FDA Tattoo Ink Guidance Document carefully. Make sure you understand what the Guidance Document says and identify if you disagree or support the language in the document. We are asking for your feedback, please fill out the form on the "Feedback Submission." 

• Identify if you disagree or support the language in the document, please quote the exact phrase you disagree with and provide supporting scientific evidence to justify the change.

• Please link the scientific evidence or the justification of changing the language.

• Answer all of the questions on the forms, if you cannot justify or provide scientific evidence to support the change your comment will not be included.

• Be honest and accurate in your answers. The information you provide will be used to make decisions, so it's important that your answers are accurate. 

• Proofread your answers before submitting the form. This will help to ensure that your answers are free of errors.

Here are some comment instructions I would tell someone looking at a FDA guidance document for the first time to give constructive comments:

• Read the guidance document carefully and thoroughly. Make sure you understand the purpose of the guidance and the specific issues it addresses.

• Identify any areas where you agree or disagree with the guidance. 

• If you agree with the guidance, you can simply state your agreement. 

• If you disagree with the guidance, you should explain why you disagree and provide any supporting evidence.

• Be specific and provide examples. Don't just say that you disagree with the guidance. Explain why you disagree and provide specific examples to support your point of view.

• Be constructive. Your goal is to help the FDA improve the guidance document, not to criticize it. Focus on providing constructive feedback that will help the FDA make the guidance document more accurate, clear, and helpful.

• Be respectful. Remember that the FDA staff, AFDO Committee members and Volunteers are collecting your comments.

Here are some additional tips for giving constructive comments:

• Start by stating your name and affiliation. This will help the FDA staff to identify you and your expertise.

• Use clear and concise language. Avoid jargon and technical terms that the FDA staff may not understand.

• Proofread your comments before submitting them on this portal. This will help to ensure that your comments are free of errors.

Using the Comment Portal Instructions

If you cannot access the forms inform a BAC Chair, please.
Here are some instructions when filling Google Forms:

• Read the FDA Tattoo Ink Guidance Document carefully. Make sure you understand what the Guidance Document says and identify if you disagree or support the language in the document. We are asking for your feedback, please fill out the form on the "Feedback Submission." 

• Identify if you disagree or support the language in the document, please quote the exact phrase you disagree with and provide supporting scientific evidence to justify the change.

• Please link the scientific evidence or the justification of changing the language.

• Answer all of the questions on the forms, if you cannot justify or provide scientific evidence to support the change your comment will not be included.

• Be honest and accurate in your answers. The information you provide will be used to make decisions, so it's important that your answers are accurate. 

• Proofread your answers before submitting the form. This will help to ensure that your answers are free of errors.