Get the free Citizens' Petition Pursuant to 21 CFR 10.30

This document is a formal petition submitted to the FDA requesting changes in the regulation and approval process for nicotine replacement therapies (NRT), outlining barriers to effective use and

How to fill out citizens petition pursuant to

How to fill out Citizens' Petition Pursuant to 21 CFR 10.30

1. Begin by obtaining the correct form for the Citizens' Petition, which can usually be found on the FDA's website.
2. Clearly write the title of the petition at the top, indicating that it is a Citizens' Petition pursuant to 21 CFR 10.30.
3. Provide a detailed description of the issue or request, including any relevant background information.
4. Include a thorough discussion of the scientific evidence or rationale supporting your petition.
5. Specify the action you are requesting from the FDA, along with any specific recommendations.
6. Include a list of all individuals or organizations that support or oppose your petition, if applicable.
7. Sign and date the petition, ensuring that your contact information is clear for follow-up.
8. Submit the petition electronically via the FDA's online system or by mail, as per the instructions provided by the FDA.

Who needs Citizens' Petition Pursuant to 21 CFR 10.30?

1. Individuals or organizations seeking to request a certain action from the FDA, such as changes in regulations, new safety information, or modifications to existing approvals.
2. Pharmaceutical companies desiring to provide new evidence for product approvals or changes.
3. Public interest groups advocating for consumer safety or health-related issues.

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.

For pdfFiller’s FAQs

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, asking for specific actions regarding food and drug regulations, including requests for the agency to take or refrain from taking certain regulatory actions.

Who is required to file Citizens' Petition Pursuant to 21 CFR 10.30?

Any individual or organization with a vested interest can file a Citizens' Petition pursuant to 21 CFR 10.30, including but not limited to consumers, healthcare professionals, industry stakeholders, and advocacy groups.

How to fill out Citizens' Petition Pursuant to 21 CFR 10.30?

To fill out a Citizens' Petition, the filer must provide detailed information including the petitioner's name and address, the nature of the request, the reasons for the request, and any relevant data or documentation that supports the petition.

What is the purpose of Citizens' Petition Pursuant to 21 CFR 10.30?

The purpose of the Citizens' Petition is to formally communicate requests to the FDA regarding regulatory matters, enabling a transparent process for individuals and organizations to seek change or clarification on FDA regulations.

What information must be reported on Citizens' Petition Pursuant to 21 CFR 10.30?

The information required includes the petitioner's contact information, a clear statement of the action requested, a statement of grounds for the request, supporting data, and any additional relevant information that could assist the FDA in addressing the petition.