113 HR 1281 EAS: U.S. House of Representatives 2014-12-08 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. 113th CONGRESS2d SessionH.R. 1281In the Senate of the United States,December 8, 2014.Amendment:

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

At the end, add the following:

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.

Secretary