[Congressional Record (Bound Edition), Volume 160 (2014), Part 12]
[House]
[Page 17457]
[From the U.S. Government Publishing Office, www.gpo.gov]




       NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2014

  Mrs. ELLMERS. Mr. Speaker, I ask unanimous consent to take from the 
Speaker's table the bill (H.R. 1281) to amend the Public Health Service 
Act to reauthorize programs under part A of title XI of such Act, with 
the Senate amendment thereto, and concur in the Senate amendment.
  The Clerk read the title of the bill.
  The SPEAKER pro tempore. The Clerk will report the Senate amendment.
  The Clerk read as follows:
  Senate amendment:

       At the end, add the following:

     SEC. 12. 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.

  Mrs. ELLMERS (during the reading). Mr. Speaker, I ask unanimous 
consent that the reading of the Senate amendment be dispensed with.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentlewoman from North Carolina?
  There was no objection.
  The SPEAKER pro tempore. Is there objection to the original request 
of the gentlewoman from North Carolina?
  There was no objection.
  A motion to reconsider was laid on the table.

                          ____________________