HHS FDA Form 3852 2022-2026 free printable template
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Center for Tobacco ProductsForm Approved: OMB No. 09100749
Expiration Date: 8/31/2025
(See PRA Statement on page 2)Report of Tobacco
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How to fill out HHS FDA Form 3852
01
Visit the HHS FDA website and download Form 3852.
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Who needs HHS FDA Form 3852?
01
Individuals or businesses seeking to use certain products regulated by the FDA.
02
Manufacturers applying for pre-market approval for new products.
03
Entities in need of clarification regarding FDA regulations.
04
Anyone filing a request for information or interpretation regarding specific FDA policies.
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What is HHS FDA Form 3852?
HHS FDA Form 3852 is a form used to report certain information about the sale of food and drug products, including compliance with the Federal Food, Drug, and Cosmetic Act.
Who is required to file HHS FDA Form 3852?
Manufacturers, packers, or distributors of certain food and drug products who are subject to registration and listing requirements are required to file HHS FDA Form 3852.
How to fill out HHS FDA Form 3852?
To fill out HHS FDA Form 3852, individuals must provide accurate product information, details regarding the manufacturer, and comply with all specific instructions provided on the form itself.
What is the purpose of HHS FDA Form 3852?
The purpose of HHS FDA Form 3852 is to collect necessary information to ensure compliance with federal regulations for food and drug products, facilitating the FDA's monitoring and enforcement activities.
What information must be reported on HHS FDA Form 3852?
Information that must be reported on HHS FDA Form 3852 includes the product name, manufacturer details, packaging information, and any relevant compliance data as required by the FDA.
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