TEST Act

To amend title IV of the Public Health Service Act to expand the clinical trial registry data bank, and for other purposes. 1. Short title This Act may be cited as the Trial and Experimental Studies Transparency Act of 2012 TEST Act 2. Expanded clinical trial registry data bank (a) In general Section 402(j) of the Public Health Service Act ( 42 U.S.C. 282(j) (1) in paragraph (1)(A)— (A) in clause (ii)— (i) by amending subclause (I) to read as follows: (I) an interventional study of a device subject to section 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act, including any interventional study of a device conducted outside of the United States the results of which are submitted to the Secretary in support of a PMA (as such term is defined in section 814.3(e) section 814.3(m) ; and (ii) in subclause (II)— (I) by striking pediatric (II) by inserting that involves data collection from human subjects (B) by amending clause (iii) to read as follows: (iii) Applicable drug clinical trial The term applicable drug clinical trial (I) an IND (as such term is defined in section 312.3 (II) an application filed under subsection (b) or (j) of such section 505 of the Federal Food, Drug, and Cosmetic Act; or (III) an application for a license under section 351. ; (C) by redesignating clauses (iv) through (ix) as clauses (v) through (x), respectively; (D) after clause (iii), by inserting the following new clause: (iv) Interventional study For purposes of clauses (ii) and (iii), the term interventional study ; and (E) in clause (vi), as redesignated by subparagraph (C) (i) in the heading, by inserting ; primary completion date date (ii) by inserting , also referred to as primary completion date means (2) in paragraph (2)— (A) in subparagraph (A)(ii)— (i) by redesignating subclauses (II), (III), and (IV) as subclauses (III), (IV), and (V), respectively; (ii) by inserting after subclause (I) the following: (II) supporting documents, including— (aa) consent documents used to enroll subjects into the trial, as approved by the Institutional Review Board or equivalent committee prior to the start of the trial; and (bb) protocol documents, as approved by the Institutional Review Board or equivalent committee prior to the start of the trial; ; and (iii) in subclause (IV), as so redesignated, in item (cc), by inserting (or, in the case of a location outside of the United States, other appropriate location information) zip code (B) in subparagraph (C)(ii) by striking 21 days after before (C) by amending subparagraph (D) to read as follows: (D) Posting of Data The Director of NIH shall ensure that clinical trial information for an applicable clinical trial submitted in accordance with this paragraph is posted publically in the registry data bank not later than 30 days after such submission is determined to meet the quality criteria established by the Director of NIH. ; (3) in paragraph (3)— (A) in subparagraph (C)— (i) by striking Not later than 1 year Subject to subparagraph (2)(C), the Secretary shall include in the registry and results data bank the following elements for an applicable clinical trial: (ii) by adding at the end the following new clause: (v) Supporting documents Final consent and protocol documents, including all dated amendments to the initial version of such documents, as approved by the Institutional Review Board or equivalent committee. ; (B) in subparagraph (D)— (i) by striking clauses (ii) and (iv); (ii) in clause (iii)— (I) by striking subclause (III); and (II) by redesignating subclause (IV) as subclause (III); and (iii) by redesignating— (I) clause (iii) as clause (ii); and (II) clauses (v) through (vii) as clauses (iii) through (v), respectively; (C) in subparagraph (E)— (i) by striking clauses (i) through (v) and inserting the following: (i) In general Except as provided in clauses (ii) and (iii), the responsible party for an applicable clinical trial shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information described in subparagraph (C) not later than 1 year after the primary completion date of such trial. (ii) Delayed submission of results with certification If the responsible party for an applicable clinical trial submits a certification that an applicable clinical trial involves a drug described in clause (iii) or a device described in clause (iv), the responsible party shall submit to the Director of NIH, for inclusion in the registry and results data bank, the clinical trial information described in subparagraphs (C) and (D) not later than the earliest of the following: (I) The later of— (aa) 30 days after the drug or device is approved, licensed, or cleared, as applicable; or (bb) 1 year after the primary completion date of the applicable clinical trial. (II) The date that is 2 years after the primary completion date of the applicable clinical trial. (iii) Drug described A drug described in this clause is a drug that contains an active ingredient, including any ester or salt, that has not been an ingredient in a drug approved in any other application under section 505 of the Federal Food, Drug, and Cosmetic Act or licensed for any use under section 351 of this Act. (iv) Device described A device described in this clause is a device that has not been approved or cleared for any use under section 510(k) or under section 515 or 520(m) of the Federal Food, Drug, and Cosmetic Act. ; (ii) by redesignating clause (vi) as clause (v); and (iii) by adding at the end the following: (vi) Public postings related to delays and extensions Information submitted by the responsible party as part of a certification for delayed submission of results submitted under clause (ii) or a request for extension submitted under clause (v) shall be posted publically in the registry data bank. ; (D) by striking subparagraph (F); (E) by redesignating subparagraphs (G) through (I) as subparagraphs (F) through (H), respectively; and (F) in subparagraph (F), as so redesignated, by inserting before the period at the end the following: is determined to meet the quality criteria established by the Director of NIH (4) in paragraph (4)(B)— (A) in clause (i)(II), by striking (3)(E)(iii) (3)(E)(ii) (B) in clause (ii)(II)— (i) by striking by both (ii) by striking and paragraph (3)(D)(ii)(II)) (b) Implementation The Secretary of Health and Human Services shall implement the amendments made by subsection (a) not later than 6 months after the date of enactment of this Act. 3. Reporting requirement Not later than 2 years after the date of the enactment of this Act, and annually thereafter, the Director of the National Institutes of Health and the Commissioner of the Food and Drug Administration shall each submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report that includes the following: (1) Based on information that is readily available in the data bank described in section 402(j) of the Public Health Service Act ( 42 U.S.C. 282(j) (A) the number of trials that the Director or Commissioner, as applicable, has identified as trials that are likely to be subject to the reporting requirements of such section; (B) of the trials identified under subparagraph (A) (i) that have complete registration information; and (ii) that have met the result reporting requirements of section 402(j) of the Public Health Service Act; and (C) whether results of the trials have been submitted by the responsible party by the due dates outlined in section 402(j) of the Public Health Service Act and, if not, whether certifications for delayed submission of such results, or requests for extensions, have been submitted by the responsible party. For purposes of this paragraph, the Secretary may use an algorithm or other technique for efficiently reviewing large amounts of data. (2) A description of any actions taken to consult with other Federal agencies under 402(j)(5)(A)(iv) of the Public Health Service Act. (3) In the case of a report submitted by the Commissioner of the Food and Drug Administration, a description of any enforcement actions taken for violations of section 301(jj) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331(jj) (A) warning letters or fines imposed related to reporting requirements; and (B) any inquiries made to responsible parties to inform those parties of any potential enforcement action. (4) In the case of a report submitted by the Director of the National Institutes of Health, a description of any actions taken to withhold grant funds from responsible parties that are not compliant with the requirements of this section as indicated in 402(j)(5)(A) of the Public Health Service Act. 4. Rulemaking related to foreign clinical studies (a) Drugs Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services shall issue final regulations to amend section 312.120 42 U.S.C. 282(j) section 312.3 21 U.S.C. 355 42 U.S.C. 262 (b) Devices Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services shall issue final regulations (including regulations amending section 814.15 42 U.S.C. 282(j)

Summary: Trial and Experimental Studies Transparency Act of 2012 [sic] or TEST Act - Amends the Public Health Service Act to expand the clinical trials that must be reported to the clinical trial registry data bank to include: (1) any interventional study of a drug, device, or biological product conducted outside of the United States the results of which are submitted to the Secretary of Health and Human Services (HHS) as support for approval of an application; and (2) postmarket surveillance of a class II or class III device that involves data collection from human subjects. Defines "interventional study" to mean a study in human beings in which individuals are assigned by an investigator, based on a protocol, to receive specific interventions to evaluate their effects on biomedical health-related outcomes. Requires submission to the data bank of supporting documents, including protocol documents and consent documents used to enroll subjects into the trial. Requires the responsible party for a clinical trial to submit clinical trial information to the data bank before the first patient is enrolled in the trial. Requires the Director of the National Institutes of Health (NIH) to post the information submitted to the data bank within 30 days after the submission is determined to meet the quality criteria established by the Director. Revises time frames for the reporting of results data to the clinical trial registry. Requires the Director and the Commissioner of Food and Drugs (FDA) to report on the number of clinical trials with information submitted to the registry and steps taken to enforce compliance with such reporting requirements.