3.0.0 3207 2023-01-11T13:22:05Z 2023-01-11T13:22:05Z House H HR 2011-10-14 112 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. BURGESS:H.R. 3207.Congress has the power to enact this legislation pursuantto the following:Article 1 Section 8 Clause 3 which states that Congress hasthe authority ``To regulate Commerce with foreign Nations,and among the several States, and with the Indian Tribes;''[Page H6977]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2011-10-14T21:03:40Z Referred to 2011-10-14T13:01:35Z 2011-10-14 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2011-10-14 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2011-10-14 Introduced in House IntroReferral Intro-H 9 Library of Congress 2011-10-14 Introduced in House IntroReferral 1000 9 Library of Congress B001248 Rep. Burgess, Michael C. [R-TX-26] Michael Burgess R TX C. 26 N P000594 Rep. Paulsen, Erik [R-MN-3] Erik Paulsen R MN 3 2011-10-14 True L000566 Rep. Latta, Robert E. [R-OH-5] Robert Latta R OH E. 5 2011-10-14 True B001243 Rep. Blackburn, Marsha [R-TN-7] Marsha Blackburn R TN 7 2011-10-14 True C000556 Rep. Coble, Howard [R-NC-6] HOWARD COBLE R NC 6 2011-11-18 False L000567 Rep. Lance, Leonard [R-NJ-7] Leonard Lance R NJ 7 2011-12-07 False M001159 Rep. McMorris Rodgers, Cathy [R-WA-5] Cathy McMorris Rodgers R WA 5 2011-12-07 False G000558 Rep. Guthrie, Brett [R-KY-2] Brett Guthrie R KY 2 2011-12-08 False M001180 Rep. McKinley, David B. [R-WV-1] David McKinley R WV B. 1 2011-12-08 False G000568 Rep. Griffith, H. Morgan [R-VA-9] H. Griffith R VA Morgan 9 2011-12-13 False Y000063 Rep. Yoder, Kevin [R-KS-3] Kevin Yoder R KS 3 2011-12-13 False T000462 Rep. Tiberi, Patrick J. [R-OH-12] PATRICK TIBERI R OH J. 12 2011-12-14 False M001151 Rep. Murphy, Tim [R-PA-18] Tim Murphy R PA 18 2012-01-27 False S000250 Rep. Sessions, Pete [R-TX-32] PETE SESSIONS R TX 32 2012-01-27 False S000822 Rep. Stearns, Cliff [R-FL-6] CLIFF STEARNS R FL 6 2012-02-08 False F000116 Rep. Filner, Bob [D-CA-51] BOB FILNER D CA 51 2012-02-13 False M001181 Rep. Meehan, Patrick [R-PA-7] Patrick Meehan R PA 7 2012-02-27 False C001048 Rep. Culberson, John Abney [R-TX-7] JOHN CULBERSON R TX ABNEY 7 2012-04-16 False M001154 Rep. Miller, Brad [D-NC-13] Brad Miller D NC 13 2012-09-11 False Health Administrative law and regulatory procedures Administrative remedies Advisory bodies Alternative dispute resolution, mediation, arbitration Department of Health and Human Services Drug safety, medical device, and laboratory regulation Government information and archives Licensing and registrations Marketing and advertising Medical tests and diagnostic methods User charges and fees Health 00 2011-10-14 Introduced in House 2012-02-14T23:05:17Z 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).

]]> Modernizing Laboratory Test Standards for Patients Act of 2011 Display Title Modernizing Laboratory Test Standards for Patients Act of 2011 Official Title as Introduced To amend the Public Health Service Act to create a pathway for premarket notification and review of laboratory-developed tests, and for other purposes. Introduced in House IH Short Titles as Introduced Modernizing Laboratory Test Standards for Patients Act of 2011 Introduced in House 2011-10-14T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112hr3207ih/xml/BILLS-112hr3207ih.xml 2011-10-14 Referred to the Subcommittee on Health. 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. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.