Title: Strengthening Antibiotic Oversight Act
Policy area: Health

Summary:
Strengthening Antibiotic Oversight Act
This bill requires the Food and Drug Administration to review the duration of use of medically-important antibiotics in animals. This applies to antibiotics approved for use in animals for a duration that exceeds 21 days.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 3099 Introduced in Senate (IS)]

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115th CONGRESS
  2d Session
                                S. 3099

 To require the review of durations of use of approved indications of 
      medically-important antibiotics labeled for use in animals.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             June 20, 2018

   Ms. Warren (for herself, Mrs. Gillibrand, Mrs. Feinstein, and Mr. 
  Blumenthal) introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
 To require the review of durations of use of approved indications of 
      medically-important antibiotics labeled for use in animals.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Strengthening Antibiotic Oversight 
Act''.

SEC. 2. REVIEW OF ANTIBIOTIC DURATION OF USE.

    (a) In General.--Not later than 6 months after the date of 
enactment of this Act, the Secretary of Health and Human Services 
(referred to in this section as the ``Secretary'') shall review the 
durations of use of approved indications of medically-important 
antibiotics labeled for use in animals. After such review, the 
Secretary shall require the sponsor of any such medically-important 
antibiotic drug with an approved indication with a duration of use in 
animals that exceeds 21 days to submit data, within one year of such 
review, to support such duration over 21 days. If, after review of the 
data submitted, the Secretary determines that the duration is not 
scientifically justified or the disease can be prevented or treated 
through other reasonable means after 21 days of treatment with such 
antibiotic drug, the Secretary shall withdraw the approval of the 
indication with a duration of use over 21 days, and issue an approval 
of a new indication with a scientifically-justified duration of use 
that is 21 days or shorter.
    (b) Process for the Review of Animal Drug Applications.--Section 
739(8) (21 U.S.C. 379j-11(8)) is amended by adding at the end the 
following:
                    ``(I) Review of approved durations of use of 
                medically-important antibiotics in accordance with 
                section 2(a) of the Strengthening Antibiotic Oversight 
                Act.''.

SEC. 3. USE OF ANIMAL DRUG USER FEES.

    Section 739(8) (21 U.S.C. 379j-11(8)), as amended by section 2, is 
further amended by adding at the end the following:
                    ``(J) Inspection of veterinary feed directives and 
                feed distribution reports maintained under section 
                558.6(c) of title 21, Code of Federal Regulations (or 
                any successor regulations) to identify amounts of 
                antibiotics used in such feed, the purposes for the use 
                of such antibiotics, and the species and production 
                classes receiving such feed, which may be done in 
                collaboration with the Department of Agriculture, and 
                reporting of such information to Congress.''.
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