H.R. 3207 · 112th Congress
Modernizing Laboratory Test Standards for Patients Act of 2011
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Never voted on. It didn't reach a floor vote before the 112th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
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BurgessSponsor18 cosponsors · 2 D, 16 R
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Blackburn
RL
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Latta
EP
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Paulsen
HC
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Coble
LL
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Lance
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McMorris Rodgers
BG
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Guthrie
DM
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McKinley
HG
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Griffith
KY
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Yoder
PT
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Tiberi
TM
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Murphy
PS
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Sessions
CS
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Stearns
BF
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Filner
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Meehan
JC
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Culberson
BM
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Miller3 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
Modernizing Laboratory Test Standards for Patients Act of 2011 - Amends the Public Health Service Act to require the Secretary of Health and Human Services (HHS) to establish a single publicly accessible test registry data bank of laboratory-developed tests and direct-to-consumer DNA tests, which shall include information on the purpose of each test, the…
What it does: CRS summary · Introduced in House · Oct 14, 2011
Modernizing Laboratory Test Standards for Patients Act of 2011 - Amends the Public Health Service Act to require the Secretary of Health and Human Services (HHS) to establish a single publicly accessible test registry data bank of laboratory-developed tests and direct-to-consumer DNA tests, which shall include information on the purpose of each test, the claimed use or uses of each test, and information regarding the analytical validity of each test.
Requires notification to the Secretary: (1) before marketing such a test, (2) after any significant modification of such a test, or (3) if the evidence of clinical validity is inadequate to support one or more of the claimed uses.
Requires the Secretary, within 90 days of receiving such notification, to determine whether the notification demonstrates clinical validity. Deems the Secretary to have authorized marketing of the test if no response is received within 90 days.
Gives the Secretary authority to order a laboratory or test-offering entity to cease offering or marketing a test if the information submitted in notifications does not demonstrate the clinical validity of the claimed uses and the test poses a risk of immediate harm to the public health.
Sets forth requirements for: (1) registration of a test-offering entity, (2) information that must be included in disseminated materials and advertising, (3) notice to the Secretary if a test may have caused or contributed to a death or serious bodily injury, and (4) sanctions for violations of this Act.
Requires the Secretary to administer this section solely through the Centers for Medicare and Medicaid Services (CMS).
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Modernizing Laboratory Test Standards for Patients Act of 2011
Latest action (Oct 14, 2011): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: Oct 14, 2011
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.