Sec. 5. Secure Medicines Supply Fund
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/bill/116/hr/6885/ih/section-5·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
There is established in the Treasury of the United States a fund, to be known as the Secure Medicines Supply Fund (in this section referred to as the Fund ), consisting of such amounts as may be deposited to the Fund pursuant to subsection
(b)to be used, in accordance with subsection (c), for the purpose of supporting and incentivizing pharmaceutical or device companies to invest in new pharmaceutical or device manufacturing capacity in the 50 States, the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands. To be eligible for investment under subsection (a), new pharmaceutical or device manufacturing capacity shall meet each of the following: The products supported by the new pharmaceutical or device manufacturing capacity do not use active pharmaceutical ingredients or parts manufactured in China or India. At least 50 percent of the active pharmaceutical ingredients or parts for the total product line of the respective company is manufactured in any of the 50 States, the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, or the Commonwealth of the Northern Mariana Islands. Amounts collected from duties imposed pursuant to section 4 shall be deposited in the Fund, to remain available until expended. Amounts collected from civil monetary penalties imposed pursuant to paragraph
(10)of section 303(f) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 333(f) ), as added by section 3(d), shall be deposited in the Fund, to remain available until expended. The Secretary of Health and Human Services shall establish a grant program to support and incentivize pharmaceutical or device companies to manufacture prescription drugs, active pharmaceutical ingredients, or devices in any of the 50 States, the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands. As a condition on receipt of a grant under this section, the recipient of the grant shall agree to use— not more than 10 percent of the grant for new or expanded manufacturing capacity; not more than 50 percent of the grant for training manufacturing workers; and not more than 25 percent of the grant for developing one or more new prescription drugs, new active pharmaceutical ingredients, or new antibiotics. All amounts used to carry out this section shall be derived from the Fund. Not later than one year after the date of enactment of this Act, and annually thereafter, the Secretary of Health and Human Services shall submit to the Congress a report on the Fund. Each such report shall address the following: The amounts deposited into the Fund in the most recent three fiscal years. The distribution of such amounts pursuant to grants under this section during the last three fiscal years, including the allocation of such amounts for— new or expanded manufacturing capacity; training workers; and developing new prescription drugs, new active pharmaceutical ingredients, or new antibiotics. In this section, the term device has the meaning given to such term in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 ). This section (other than subsection (e)) shall cease to have effect beginning on the date that is 10 years after the date of the enactment of this Act. If any amounts remain in the Fund after the date described in subsection (f), the Secretary of the Treasury shall transfer such amounts to the general fund of the Treasury.
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