[Congressional Record Volume 163, Number 131 (Wednesday, August 2, 2017)]
[Senate]
[Page S4778]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  SA 751. Mr. REED submitted an amendment intended to be proposed by 
him to the bill H.R. 2430, to amend the Federal Food, Drug, and 
Cosmetic Act to revise and extend the user-fee programs for 
prescription drugs, medical devices, generic drugs, and biosimilar 
biological products, and for other purposes; which was ordered to lie 
on the table; as follows:

       On page 97, strike line 20 and all that follows through 
     line 9 on page 98 and insert the following:
       ``(k) Relation to Orphan Drugs.--
       ``(1) In general; exemption for orphan indications.--Unless 
     the Secretary requires otherwise by regulation, this section 
     does not apply to any drug for an indication for which orphan 
     designation has been granted under section 526, except as 
     provided in paragraph (2).
       ``(2) Applicability despite orphan designation of certain 
     indications.--This section shall apply with respect to a drug 
     or biological product for which an indication has been 
     granted orphan designation under section 526--
       ``(A) if the pediatric cancer investigation described in 
     subsection (a)(3) applies to the drug or biological product 
     as described in subsection (a)(1)(B); or
       ``(B) if such orphan indication is limited to a pediatric 
     subpopulation and such indication in the adult population 
     does not qualify for orphan designation.
       ``(3) Effect of application.--Application of this section 
     to drugs and biological products described in paragraph 
     (2)(B) does not limit the applicability of section 526 to 
     such drugs and biological products.''.

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