S.Amdt. 3333

SA 3333. Mr. BLUMENTHAL submitted an amendment intended to be
proposed by him to the bill S. 524, to authorize the Attorney General
to award grants to address the national epidemics of prescription
opioid abuse and heroin use; which was ordered to lie on the table; as
follows:
At the end, add the following:

SEC. 705. REMS FOR IMMEDIATE RELEASE OPIOID ANALGESICS.

Not later than 120 days after the date of enactment of this
Act, the Secretary of Health and Human Services shall require
a risk evaluation and mitigation strategy under section 505-1
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1)
to be submitted for drugs that are immediate release opioid
analgesics, including for such drugs for which there is an
approved covered application (as defined in such section) and
for such drugs for which a covered application has been
submitted but not yet approved.
______