Modernizing Laboratory Test Standards for Patients Act of 2011
The source supplies the latest action, but no lifecycle stage.
Latest action (14 Oct 2011): Referred to the Subcommittee on Health.
What this bill does
The Modernizing Laboratory Test Standards for Patients Act of 2011 would establish a single, publicly accessible registry for certain laboratory tests. This registry would contain information about the test's purpose, its claimed uses, and its analytical validity. Laboratories and entities offering direct-to-consumer DNA tests would be required to notify the Secretary of Health and Human Services before marketing a test, after significant modifications, or if evidence of clinical validity becomes inadequate for its claimed uses.
Under this bill, the Secretary of Health and Human Services would have 90 days to determine if the submitted information demonstrates clinical validity. If the Secretary does not respond within this timeframe, the marketing of the test would be considered authorized. The Secretary would also be empowered to order a laboratory or entity to stop offering or marketing a test if the submitted information does not demonstrate clinical validity and the test poses a risk of immediate harm to public health. The bill also outlines requirements for registering entities, advertising content, and reporting serious adverse events, with sanctions for violations.
This bill was introduced in the House of Representatives in October 2011. As of its introduction, its latest action was simply being introduced. It was referred to the Committee on Energy and Commerce.
Plain-English summary generated by Bill100 AI from the official record. Always verify against the source below.
Official summary
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).
Timeline
14 Oct 2011
Referred to the Subcommittee on Health.
Common questions
- What does H.R. 3207 do?
- The Modernizing Laboratory Test Standards for Patients Act of 2011 would establish a single, publicly accessible registry for certain laboratory tests. This registry would contain information about the test's purpose, its claimed uses, and its analytical validity. Laboratories and entities offering direct-to-consumer DNA tests would be required to notify the Secretary of Health and Human Services before marketing a test, after significant modifications, or if evidence of clinical validity becomes inadequate for its claimed uses. Under this bill, the Secretary of Health and Human Services would have 90 days to determine if the submitted information demonstrates clinical validity. If the Secretary does not respond within this timeframe, the marketing of the test would be considered authorized. The Secretary would also be empowered to order a laboratory or entity to stop offering or marketing a test if the submitted information does not demonstrate clinical validity and the test poses a risk of immediate harm to public health. The bill also outlines requirements for registering entities, advertising content, and reporting serious adverse events, with sanctions for violations. This bill was introduced in the House of Representatives in October 2011. As of its introduction, its latest action was simply being introduced. It was referred to the Committee on Energy and Commerce.
- Has H.R. 3207 become law?
- The source does not supply a confirmed lifecycle stage for H.R. 3207. Check the latest action and official source below.
- Who sponsored H.R. 3207?
- H.R. 3207 was sponsored by Rep. Burgess, Michael C. [R-TX-26] (R-TX), with 18 cosponsors.
- What's the latest action on H.R. 3207?
- Referred to the Subcommittee on Health. (14 Oct 2011).
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