[Congressional Record Volume 166, Number 140 (Thursday, August 6, 2020)]
[Senate]
[Pages S5305-S5306]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SA 2613. Mr. ENZI (for himself and Ms. Hassan) submitted an amendment
intended to be proposed to amendment SA 2499 proposed by Mr. McConnell
to the bill S. 178, to condemn gross human rights violations of ethnic
Turkic Muslims in Xinjiang, and calling for an end to arbitrary
detention, torture, and harassment of these communities inside and
outside China; which was ordered to lie on the table; as follows:
At the appropriate place, insert the following:
SEC. __. AUTHORITY TO DESTROY COUNTERFEIT DEVICES.
(a) In General.--Section 801(a) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 381(a)) is amended--
(1) in the fourth sentence, by inserting ``or counterfeit
device'' after ``counterfeit drug''; and
(2) by striking ``The Secretary of the Treasury shall cause
the destruction of'' and all that follows through ``liable
for costs pursuant to subsection (c).'' and inserting the
[[Page S5306]]
following: ``The Secretary of the Treasury shall cause the
destruction of any such article refused admission unless such
article is exported, under regulations prescribed by the
Secretary of the Treasury, within 90 days of the date of
notice of such refusal or within such additional time as may
be permitted pursuant to such regulations, except that the
Secretary of Health and Human Services may destroy, without
the opportunity for export, any drug or device refused
admission under this section, if such drug or device is
valued at an amount that is $2,500 or less (or such higher
amount as the Secretary of the Treasury may set by regulation
pursuant to section 498(a)(1) of the Tariff Act of 1930 (19
U.S.C. 1498(a)(1))) and was not brought into compliance as
described under subsection (b). The Secretary of Health and
Human Services shall issue regulations providing for notice
and an opportunity to appear before the Secretary of Health
and Human Services and introduce testimony, as described in
the first sentence of this subsection, on destruction of a
drug or device under the seventh sentence of this subsection.
The regulations shall provide that prior to destruction,
appropriate due process is available to the owner or
consignee seeking to challenge the decision to destroy the
drug or device. Where the Secretary of Health and Human
Services provides notice and an opportunity to appear and
introduce testimony on the destruction of a drug or device,
the Secretary of Health and Human Services shall store and,
as applicable, dispose of the drug or device after the
issuance of the notice, except that the owner and consignee
shall remain liable for costs pursuant to subsection (c).''.
(b) Definition.--Section 201(h) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321(h)) is amended--
(1) by redesignating subparagraphs (1), (2), and (3) as
clauses (A), (B), and (C), respectively; and
(2) after making such redesignations--
(A) by striking ``(h) The term'' and inserting ``(h)(1) The
term''; and
(B) by adding at the end the following:
``(2) The term `counterfeit device' means a device which,
or the container, packaging, or labeling of which, without
authorization, bears a trademark, trade name, or other
identifying mark, imprint, or symbol, or any likeness
thereof, or is manufactured using a design, of a device
manufacturer, packer, or distributor other than the person or
persons who in fact manufactured, packed, or distributed such
device and which thereby falsely purports or is represented
to be the product of, or to have been packed or distributed
by, such other device manufacturer, packer, or distributor.
``(3) For purposes of subparagraph (2)--
``(A) the term `manufactured' refers to any of the
following activities: manufacture, preparation, propagation,
compounding, assembly, or processing; and
``(B) the term `manufacturer' means a person who is engaged
in any of the activities listed in clause (A).''.
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