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Full Text of this Amendment
SA 891. Mr. BURR (for himself, Ms. Klobuchar, and Mr. Bennet) submitted an amendment intended to be proposed by him to the bill H.R. 2112, making appropriations for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies programs for the fiscal year ending September 30, 2012, and for other purposes; which was ordered to lie on the table; as follows:
At the appropriate place in title VII of division A, insert the following:
SEC. __. MANAGEMENT AND INNOVATION REVIEW.
(a) In General.--Not later than 60 days after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the "Secretary"), acting through the Commissioner of Food and Drugs, shall enter into a contract with an eligible entity to carry out the activities described in subsection (c).
(b) Eligible Entity.--To be eligible to enter into a contract with the Secretary under subsection (a), an entity shall--
(1) be an entity with experience in evaluating the management and operating structure of large organizations; and
(2) submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require.
(c) Activities.--The entity with which the Secretary enters into the contract under subsection (a) shall, pursuant to such contract, conduct an extensive review of the management and regulatory processes at the Center for Devices and Radiological Health of the Food and Drug Administration to ensure any actions carried out by such Center take into consideration the potential impacts on innovation with respect to medical devices and other products regulated by such Center.
(d) Report.--Not later than 1 year after the date that the Secretary enters into the contract with the eligible entity under subsection (a), such entity shall submit to Congress and the Secretary a report that describes the findings and recommendations of such entity based on the review conducted under subsection (c).
(e) Funding.--To carry out this section, the Secretary shall use funds otherwise made available under this division for the operations of the Office of the Commissioner of Food and Drugs.
(As printed in the Congressional Record for the Senate on Oct 19, 2011.)
At the appropriate place in title VII of division A, insert the following:
SEC. __. MANAGEMENT AND INNOVATION REVIEW.
(a) In General.--Not later than 60 days after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the "Secretary"), acting through the Commissioner of Food and Drugs, shall enter into a contract with an eligible entity to carry out the activities described in subsection (c).
(b) Eligible Entity.--To be eligible to enter into a contract with the Secretary under subsection (a), an entity shall--
(1) be an entity with experience in evaluating the management and operating structure of large organizations; and
(2) submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require.
(c) Activities.--The entity with which the Secretary enters into the contract under subsection (a) shall, pursuant to such contract, conduct an extensive review of the management and regulatory processes at the Center for Devices and Radiological Health of the Food and Drug Administration to ensure any actions carried out by such Center take into consideration the potential impacts on innovation with respect to medical devices and other products regulated by such Center.
(d) Report.--Not later than 1 year after the date that the Secretary enters into the contract with the eligible entity under subsection (a), such entity shall submit to Congress and the Secretary a report that describes the findings and recommendations of such entity based on the review conducted under subsection (c).
(e) Funding.--To carry out this section, the Secretary shall use funds otherwise made available under this division for the operations of the Office of the Commissioner of Food and Drugs.
(As printed in the Congressional Record for the Senate on Oct 19, 2011.)
