[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1281 Engrossed Amendment Senate (EAS)]

                  In the Senate of the United States,

                                                      December 8, 2014.
    Resolved, That the bill from the House of Representatives (H.R. 
1281) entitled ``An Act to amend the Public Health Service Act to 
reauthorize programs under part A of title XI of such Act.'', do pass 
with the following

                               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.

            Attest:

                                                             Secretary.
113th CONGRESS

  2d Session

                               H.R. 1281

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                               AMENDMENT