[Congressional Record (Bound Edition), Volume 160 (2014), Part 12]
[Senate]
[Page 17234]
[From the U.S. Government Publishing Office, www.gpo.gov]




       NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2014

  Mr. REID. I ask unanimous consent that the Senate proceed to the 
consideration of H.R. 1281.
  The PRESIDING OFFICER. The clerk will report the bill by title.
  The bill clerk read as follows:

       A bill (H.R. 1281) to amend the Public Health Service Act 
     to reauthorize programs under part A of title XI of such Act.

  There being no objection, the Senate proceeded to consider the bill.
  Mr. REID. I ask unanimous consent that the Paul amendment, which is 
at the desk, be agreed to; the bill, as amended, be read a third time 
and passed; and the motion to reconsider be considered made and laid 
upon the table with no intervening action or debate.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The amendment (No. 3976) was agreed to, as follows:

 (Purpose: To clarify rules relating to newborn screening research and 
                           informed consent)

       At the end, add the following:

     SEC. __. INFORMED CONSENT FOR NEWBORN SCREENING RESEARCH.

       (a) In General.--Research on newborn dried blood spots 
     shall be considered research carried out on human subjects 
     meeting the definition of section 46.102(f)(2) of title 45, 
     Code of Federal Regulations, for purposes of Federally funded 
     research conducted pursuant to the Public Health Service Act 
     until such time as updates to the Federal Policy for the 
     Protection of Human Subjects (the Common Rule) are 
     promulgated pursuant to subsection (c). For purposes of this 
     subsection, sections 46.116(c) and 46.116(d) of title 45, 
     Code of Federal Regulations, shall not apply.
       (b) Effective Date.--Subsection (a) shall apply only to 
     newborn dried blood spots used for purposes of Federally 
     funded research that were collected not earlier than 90 days 
     after the date of enactment of this Act.
       (c) Regulations.--Not later than 6 months after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services shall promulgate proposed regulations related to the 
     updating of the Federal Policy for the Protection of Human 
     Subjects (the Common Rule), particularly with respect to 
     informed consent. Not later than 2 years after such date of 
     enactment, the Secretary shall promulgate final regulations 
     based on such proposed regulations.

  The amendment was ordered to be engrossed, and the bill to be read a 
third time.
  The bill was read the third time.
  The bill (H.R. 1281), as amended, was passed.

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