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This document provides the FDA's determination of the regulatory review period for SOLIRIS, a human biological product, including details on the submission of patent extension applications and the

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3. Government agencies responsible for enforcing the regulations outlined in the interim final rule.
4. Legal professionals or advisors who may need to assist their clients in complying with the requirements set forth in the interim final rule.

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What is interim final rule?

An interim final rule is a temporary rule that is put into effect immediately, without going through the usual notice and comment period. It is used when there is an urgent need to address a specific issue or to implement a new law or regulation.

Who is required to file interim final rule?

It depends on the specific rule and the agency issuing it. In general, agencies have the authority to issue interim final rules, but they are required to provide a rationale for bypassing the normal rulemaking process. It is important to consult the specific rule and agency to determine who is required to file.

How to fill out interim final rule?

To fill out an interim final rule, you will need to carefully review the specific rule and any accompanying guidance provided by the issuing agency. This will outline the information and documentation that needs to be included in the filing. It is recommended to consult with legal counsel or compliance experts to ensure all requirements are met.

What is the purpose of interim final rule?

The purpose of an interim final rule is to address an urgent need or implement a new law or regulation in a timely manner. It allows agencies to take immediate action without going through the lengthy notice and comment period. Interim final rules are often used when there is an imminent threat to public health, safety, or welfare.

What information must be reported on interim final rule?

The specific information that must be reported on an interim final rule will vary depending on the nature of the rule and the agency issuing it. In general, the rule should include a clear statement of the purpose and need for the rule, an explanation of how the rule will address that need, and any supporting data or evidence. It is important to consult the specific rule and agency for detailed reporting requirements.