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This document is a citizens' petition addressed to the FDA requesting classification of dental amalgam and warnings regarding the toxicity of dental mercury to be issued to dentists and patients.
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How to fill out citizens petition pursuant to
How to fill out Citizens' Petition Pursuant to 21 CFR 10.30
01
Identify the issue or concern that requires a petition.
02
Gather relevant scientific data, literature, and other supportive information.
03
Draft the petition, including the specific request and rationale.
04
Include personal and contact information.
05
Ensure compliance with the format and requirements stated in 21 CFR 10.30.
06
Submit the petition to the appropriate FDA office via mail or electronic submission.
Who needs Citizens' Petition Pursuant to 21 CFR 10.30?
01
Individuals or organizations seeking to request a change in FDA regulations or policies.
02
Manufacturers looking for specific regulatory guidance or exceptions.
03
Consumer advocacy groups aiming to address public health concerns.
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People Also Ask about
What is a suitability petition in the FDA?
A suitability petition is a request by a drug sponsor (called the “petitioner”) to submit an abbreviated new animal drug application (ANADA) for a proposed generic new animal drug that differs from the reference listed new animal drug (RLNAD).
How do I submit a petition to the FDA?
FDA encourages that copies of petitions and notifications be submitted in electronic form. Electronic submissions should be submitted in a standard format such as a Word file, or PDF if also accompanied by a Word file. Lengthy electronic submissions should be divided into easily retrievable files.
What is a citizen's petition to the FDA?
A citizen petition is a way for individuals, regulated industry representatives, or consumer groups to petition FDA to issue, amend, revoke a regulation, or to take other administrative action. The requirements for a citizen petition are set out in 21 CFR 10.30.
What is the 21 CFR Part 10?
(a) Part 10 governs practices and procedures for petitions, hearings, and other administrative proceedings and activities conducted by the Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and other laws which the Commissioner of Food and Drugs administers.
What are some examples of the FDA?
FDA, an agency within the U.S. Department of Health and Human Services, protects public health by regulating human and veterinary drugs, vaccines and other biological products, medical devices, our nation's food supply, cosmetics, dietary supplements, electronic radiation emitting products, and tobacco products.
What is a citizen petition for the FDA?
A citizen petition is a way for individuals, regulated industry representatives, or consumer groups to petition FDA to issue, amend, revoke a regulation, or to take other administrative action.
What is the FDA 505 Q guidance?
Under section 505(q)(1)(E), FDA may deny a petition at any point if the Agency determines that 122 a petition or a supplement to the petition was submitted with the primary purpose of delaying the 123 approval of an application and the petition does not on its face raise valid scientific or regulatory 124 issues.
What is the FDA 505 Q guidance?
Under section 505(q)(1)(E), FDA may deny a petition at any point if the Agency determines that 122 a petition or a supplement to the petition was submitted with the primary purpose of delaying the 123 approval of an application and the petition does not on its face raise valid scientific or regulatory 124 issues.
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What is Citizens' Petition Pursuant to 21 CFR 10.30?
A Citizens' Petition pursuant to 21 CFR 10.30 is a formal request submitted to the FDA requesting the agency to take or refrain from taking a regulatory action.
Who is required to file Citizens' Petition Pursuant to 21 CFR 10.30?
Any individual or entity can file a Citizens' Petition; there is no specific requirement for who must file it, but it is often used by industry stakeholders, consumers, or advocacy groups.
How to fill out Citizens' Petition Pursuant to 21 CFR 10.30?
To fill out a Citizens' Petition, you must provide your name, address, and a clear statement of the request, along with any supporting information and arguments to justify the action sought.
What is the purpose of Citizens' Petition Pursuant to 21 CFR 10.30?
The purpose of the Citizens' Petition is to formally ask the FDA to address regulatory issues or concerns, enabling stakeholders to seek clarification or changes in policy or regulation.
What information must be reported on Citizens' Petition Pursuant to 21 CFR 10.30?
The petition must include the petitioner's name and address, a statement of the action requested, the grounds for the request, and any relevant information or data supporting the request.
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