S.Amdt. 2895

SA 2895. Mr. BROWN (for himself, Mr. Schumer, and Mr. Sanders)
submitted an amendment intended to be proposed to amendment SA 2786
proposed by Mr. Reid (for himself, Mr. Baucus, Mr. Dodd, and Mr.
Harkin) to the bill H.R. 3590, to amend the Internal Revenue Code of
1986 to modify the first-time homebuyers credit in the case of members
of the Armed Forces and certain other Federal employees, and for other
purposes; which was ordered to lie on the table; as follows:

On page 1906, between lines 5 and 6, insert the following:
(i) Biological Product Exclusivity Period.--
(1) Amendment to the public health service act.--Section
351 of the Public Health Service Act (as amended by
subsections (a) and (g)), is further amended--
(A) in subsection (k)(7), by striking subparagraph (A) and
inserting the following:
``(A) Effective date of biosimilar application approval.--
``(i) In general.--Approval of an application under this
subsection may not be made effective by the Secretary until
the earlier of--

``(I) the date that is 12 years after the date on which the
reference product was first licensed under subsection (a); or
``(II) the date on which the Secretary determines that the
gross sales in the United States of the reference product
equals or exceeds $3,500,000,000.

``(ii) Annual reporting.--As a condition for receiving the
period of exclusivity described in clause (i), a person who
receives a license for a biological product under subsection
(a) shall, not later than January 31 of each year, report to
the Secretary the amount of the annual gross sales in the
United States in the preceding calendar year for such
biological product.''; and
(B) in subsection (m)(2)(A), by striking ``12 years and 6
months rather than 12 years'' and inserting ``the date that
is 6 months after the date described in subsection
(k)(7)(A)(i) rather than the date described in such
subsection.''.
(2) Conforming amendment.--Section 7002(h)(2) of this Act
is amended by striking ``the 12-year period described in
subsection (k)(7) of such section 351'' and inserting ``the
period of exclusivity described in subsection (k)(7)(A)(i) of
such section 351''.
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