Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition is a 6-page legal document that was released by the U.S. Department of Health and Human Services - U.S. Food and Drug Administration on March 10, 2003 and used nation-wide.

FAQ

Q: What is the purpose of this document?A: The purpose of this document is to request comments on the use of aluminum in large and small volume parenterals used in total parenteral nutrition.

Q: What are parenterals?A: Parenterals are medications or nutrients that are given through injections or infusions.

Q: What is total parenteral nutrition?A: Total parenteral nutrition is a method of providing nutrition to individuals who are unable to eat or absorb nutrients through the gastrointestinal tract.

Q: Why is aluminum a concern in parenterals?A: Aluminum can be toxic to the body in high amounts and there is a concern about the potential exposure to aluminum from parenteral products.

Q: What is the purpose of the comment request?A: The purpose of the comment request is to gather feedback and information from the public and stakeholders on the use of aluminum in parenterals, specifically in total parenteral nutrition.

Q: Who is responsible for reviewing this document?A: The Office of Management and Budget (OMB) is responsible for reviewing this document.

Q: What is OMB?A: The Office of Management and Budget (OMB) is a part of the executive branch of the U.S. federal government and is responsible for assisting the President in preparing the budget, overseeing the implementation of federal policies, and evaluating the effectiveness of federal programs.