S.Amdt. 2961

SA 2961. Mrs. SHAHEEN 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 1925, between lines 14 and 15, insert the
following:

Subtitle C--Provisions Relating to Generic Drugs

SEC. 7201. LABELING CHANGES.

Section 505(j) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(j)) is amended by adding at the end the
following:
``(10)(A) If the proposed labeling of a drug that is the
subject of an application under this subsection differs from
the listed drug due to a labeling revision described under
clause (i), the drug that is the subject of such application
shall, notwithstanding any other provision of this Act, be
eligible for approval and shall not be considered misbranded
under section 502 if--
``(i) the application is otherwise eligible for approval
under this subsection but for expiration of patent, an
exclusivity period, or of a delay in approval described in
paragraph (5)(B)(iii), and a revision to the labeling of the
listed drug has been approved by the Secretary within 60 days
of such expiration;
``(ii) the labeling revision described under clause (i)
does not include a change to the `Warnings' section of the
labeling;
``(iii) the sponsor of the application under this
subsection agrees to submit revised labeling of the drug that
is the subject of such application not later than 60 days
after the notification of any changes to such labeling
required by the Secretary; and
``(iv) such application otherwise meets the applicable
requirements for approval under this subsection.
``(B) If, after a labeling revision described in
subparagraph (A)(i), the Secretary determines that the
continued presence in interstate commerce of the labeling of
the listed drug (as in effect before the revision described
in subparagraph (A)(i)) adversely impacts the safe use of the
drug, no application under this subsection shall be eligible
for approval with such labeling.''.
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