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This document is a federal notice regarding the revocation of an outdated advisory opinion related to sunscreen products issued by the FDA, indicating changes in regulatory stance on the classification

How to fill out revocation of advisory opinion

How to fill out Revocation of Advisory Opinion Entitled ‘FD&C Act Trade Correspondence 61’

1. Obtain the Revocation of Advisory Opinion form from the appropriate regulatory agency.
2. Carefully read the instructions provided with the form to ensure compliance.
3. Fill in the necessary personal and business information as required on the form.
4. Clearly indicate your request for the revocation of the Advisory Opinion entitled ‘FD&C Act Trade Correspondence 61’.
5. Provide any additional details or justifications required to support your request.
6. Review the filled form for accuracy and completeness.
7. Sign and date the form as instructed.
8. Submit the completed form to the appropriate agency through the recommended submission method (e.g., mail, fax, or online portal).
9. Keep a copy of the submitted form and any correspondence for your records.

Who needs Revocation of Advisory Opinion Entitled ‘FD&C Act Trade Correspondence 61’?

1. Individuals or organizations that rely on the Advisory Opinion for guidance but wish to contest or discontinue its application.
2. Entities that have changes in their business practices that no longer align with the recommendations in the Advisory Opinion.
3. Parties involved in legal or regulatory disputes that necessitate a reevaluation of the current advisory opinion.

For pdfFiller’s FAQs

What is Revocation of Advisory Opinion Entitled ‘FD&C Act Trade Correspondence 61’?

The Revocation of Advisory Opinion Entitled 'FD&C Act Trade Correspondence 61' refers to the official action taken to cancel or invalidate a previously issued advisory opinion that provided guidance under the Federal Food, Drug, and Cosmetic Act regarding trade correspondence.

Who is required to file Revocation of Advisory Opinion Entitled ‘FD&C Act Trade Correspondence 61’?

Organizations or individuals who rely on the previously issued advisory opinion and seek to clarify their compliance with FDA regulations may be required to file the revocation.

How to fill out Revocation of Advisory Opinion Entitled ‘FD&C Act Trade Correspondence 61’?

To fill out the Revocation of Advisory Opinion, one must provide specific details such as the title of the advisory opinion being revoked, the reasons for revocation, and any relevant contact information, ensuring that the form is completed in accordance with FDA guidelines.

What is the purpose of Revocation of Advisory Opinion Entitled ‘FD&C Act Trade Correspondence 61’?

The purpose is to formally notify stakeholders that the guidance provided in the original advisory opinion is no longer valid, thus ensuring that organizations conform to the most current regulations and guidelines from the FDA.

What information must be reported on Revocation of Advisory Opinion Entitled ‘FD&C Act Trade Correspondence 61’?

The information that must be reported includes the name and address of the entity filing the revocation, the title and date of the advisory opinion being revoked, the rationale for the revocation, and any other pertinent details that justify the action.