Senate Bill 3449
117th Congress(2021-2022)
Registration of Certain Foreign Establishments Act
Introduced
Introduced in Senate on Jan 10, 2022
Origin Chamber
Senate
Type
Bill
Bill
The primary form of legislative measure used to propose law. Depending on the chamber of origin, bills begin with a designation of either H.R. or S. Joint resolution is another form of legislative measure used to propose law.
Bill Number
3449
Congress
117
Policy Area
Health
Health
Primary focus of measure is science or practice of the diagnosis, treatment, and prevention of disease; health services administration and funding, including such programs as Medicare and Medicaid; health personnel and medical education; drug use and safety; health care coverage and insurance; health facilities. Measures concerning controlled substances and drug trafficking may fall under Crime and Law Enforcement policy area.
No Senate votes have been held for this bill.
Summary
Registration of Certain Foreign Establishments Act
This bill expands statutory provisions that require foreign manufacturers of drugs or medical devices for the U.S. market to register with the Food and Drug Administration.
Specifically, if an establishment outside of the United States manufactures (or otherwise processes or prepares) a drug or medical device to be imported (or offered for import) into the United States, the establishment must comply with the registration requirements even if the drug or medical device in question undergoes further manufacturing at another non-U.S. establishment prior to importation into the United States.
January 10, 2022
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01/10/2022
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
01/10/2022
Introduced in Senate
Public Record
Record Updated
Dec 30, 2022 3:48:58 AM