Sec. 8. Report on additional exclusion
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Not later than 1 year after the date of enactment of this Act, the Federal Trade Commission shall submit to the Committee on the Judiciary of the Senate and the Committee on the Judiciary of the House of Representatives a recommendation, and the Commission’s basis for such recommendation, regarding a potential amendment to include in section 27(b) of the Federal Trade Commission Act (as added by section 3) an additional exclusion for consideration granted by an NDA holder to a ANDA filer or by a biological product license holder to a biosimilar biological product application filer as part of the resolution or settlement, a release, waiver, or limitation of a claim for damages or other monetary relief.
In this section, the terms ANDA filer , biological product license holder , biosimilar biological product application filer , and NDA holder have the meanings given such terms in section 27(d) of the Federal Trade Commission Act (as added by section 3).