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108hr5252ih | (d) Submission of required information
(1) Submission of registration information
(A) In general
A registration of a clinical trial under subsection (a)(1)(A) is in accordance with this paragraph if, subject to subparagraph (B), the registration is in such form and is submitted in such manner as the Secretary requir... |
108hr5252ih | (ii) The disease or condition with which the trial is concerned. (iii) The medical intervention or interventions being investigated in the trial. (iv) A statement that— (I) identifies the product as an unapproved product or as an approved product, as applicable; and (II) in addition, in the case of an approved product,... |
108hr5252ih | (vii) Information on— (I) study design; (II) methods; (III) study phase; and (IV) study type. (viii) The definition of the primary and secondary outcomes for the trial. (ix) The length of time for which data on the primary and secondary outcomes will be collected on each patient. (x) Eligibility criteria for participat... |
108hr5252ih | (xiii) The anticipated or actual date of final data collection from subjects in the trial on the primary outcome. (xiv) The identity of each responsible person for the trial. (xv) Sources of funding for the trial in addition to the award under this Act. (xvi) The identity of the principal investigator in the trial. (xv... |
108hr5252ih | (xix) After the initial submission of the registration, periodic updates to reflect changes to information provided under this subparagraph and subparagraph (B), which updates— (I) are provided not less frequently than once every six months until the results of the trial are submitted under paragraph (2)(A)(i) or a wai... |
108hr5252ih | (B) Serious or life-threatening diseases; test of effectiveness
In the case of a registration under subsection (a)(1)(A) of a clinical trial to test the effectiveness of the use of a product with respect to a serious or life-threatening disease or condition, the registration is in accordance with this paragraph if, in... |
108hr5252ih | (iii) A point of contact for individuals desiring to enroll as subjects in the trial, including a single point of contact for all trial sites. (iv) The status of the trial with respect to the enrollment of subjects, stated for the trial in general and for individual trial sites. |
108hr5252ih | (v) Information that may be available— (I) under a treatment investigational new drug application, or a treatment investigational device exemption, that has been submitted to the Secretary under section 561(c) of the Federal Food, Drug, and Cosmetic Act (relating to expanded access protocols); or (II) as a Group C canc... |
108hr5252ih | (2) Submission of results of trial
(A) In general
For purposes of subsection (a)(1)(B), information on the results of a clinical trial is provided in accordance with this paragraph if, subject to subparagraphs (B) and (C), the following conditions are met: (i) The results are submitted— (I) not later than 12 months a... |
108hr5252ih | (ii) The results are provided in the form of a structured abstract and in such manner as the Secretary may require. (iii) The results consist of information determined by the Secretary to be important to clinicians or researchers, in a form that ensures that the information is accurate and not likely to mislead or dist... |
108hr5252ih | (IV) Basic demographic information on subjects. (V) In the group of subjects receiving the product, and in each comparison group of subjects, the percentage of individuals who decided to cease participation as subjects and the reasons for ceasing participation. (VI) Information on significant adverse events in subjects... |
108hr5252ih | (iv) If the trial is investigating an unapproved use of an approved product, a statement is submitted to the data bank that the Food and Drug Administration, as applicable— (I) is currently reviewing an application for approval of the unapproved use; (II) has disapproved such an application; (III) has reviewed such an ... |
108hr5252ih | (v) After the initial submission of the results, periodic updates are submitted to the data bank to reflect changes in the information submitted under this subparagraph, which updates— (I) are provided not less frequently than once every six months during the 10-year period beginning on the date on which the results ar... |
108hr5252ih | An article published in such a journal is a covered article for purposes of this clause if— (I) the article discusses the results of the trial; (II) the responsible person or the principal investigator for the clinical trial contributed to the article; and (III) MEDLINE includes a citation to the article. |
108hr5252ih | (vii) If the due date under clause (i) for the trial is a date that is more than three years after the date on which the trial was registered under subsection (a)(1)(A): (I) Upon the expiration of such three-year period, the responsible person for the trial submits to the data bank a report that describes the progress ... |
108hr5252ih | (II) For each two-year period that lapses after the submission of the report under subclause (I), the responsible person submits to the data bank an additional report that describes such progress, except that no report is required under this subclause after such due date. (B) Extensions
(i) In general
The Secretary m... |
108hr5252ih | More than one such extension may be provided by the Secretary for the clinical trial involved. |
108hr5252ih | (ii) Extensions regarding journal publication
(I) Article under consideration for publication
The Secretary shall under clause (i) provide an extension of 18 months regarding the submission of the results of a clinical trial if— (aa) the request under such clause demonstrates that an article providing the information... |
108hr5252ih | (II) Article accepted for publication
If the responsible person for a clinical trial has received an extension under subclause (I) for the trial, the Secretary shall provide an additional extension of six months, beginning upon the expiration of such first extension, if the person demonstrates to the Secretary, before... |
108hr5252ih | (C) Waivers regarding results of trial
With respect to the requirement under subsection (a)(1)(B) to submit to the Secretary the results of a clinical trial, the Secretary may waive the requirement upon a written request to the Secretary by the responsible person for the trial if the Secretary determines that extraord... |
108hr5252ih | (3) Tracking of changes in information submitted to data bank
The Secretary shall ensure that updates to the data bank submitted under paragraphs (1)(A)(xviii) and (2)(A)(v) do not result in the removal from the data bank of the original submissions or of any preceding updates, and that information in the data bank is... |
108hr5252ih | Information required in this section to be submitted to the data bank shall not be considered confidential commercial information or trade secrets, notwithstanding any other provision of law. (2) Prohibition against fees
The Secretary may not impose a fee for providing access to information in the data bank. (3) Inter... |
108hr5252ih | The Secretary shall ensure that— (i) such a site, or a portion of a site, is designed specifically for use by clinicians and researchers; and (ii) such a site, or a portion of a site, is designed specifically for use by patients seeking to enroll as subjects in clinical trials. |
108hr5252ih | (B) Relation to certain internet site
The Secretary shall ensure that the Internet site or portion thereof operated under subparagraph (A)(ii) includes information of the type that was available on ClinicalTrials.gov as of the day before the date of the enactment of the Fair Access to Clinical Trials Act (relating to ... |
108hr5252ih | (4) Specific means of disclosure
With respect to information in the data bank that is required in paragraph (5) to be disclosed, all disclosures shall be made through an Internet site or sites under paragraph (3) and any other means determined appropriate by the Secretary, except that in the case of information of the... |
108hr5252ih | (5) Required disclosures; authority of secretary for exclusions
(A) Clinicians and researchers
With respect to means of disclosure under this subsection that are intended for clinicians and researchers, the Secretary shall through such means disclose all information in the data bank, except that the Secretary may exc... |
108hr5252ih | (B) Patients seeking enrollment as subjects in clinical trials
With respect to means of disclosure under this subsection that are intended for patients seeking to enroll as subjects in clinical trials, the Secretary shall through such means disclose all information in the data bank, except that the Secretary may exclu... |
108hr5252ih | (6) Registration information; date of disclosure
In the case of information regarding a clinical trial that is contained in the data bank pursuant to subparagraph (A) or (B) of subsection (d)(1), disclosures required in paragraph (5) shall begin in accordance with the following: (A) All such disclosures shall begin pr... |
108hr5252ih | (7) Results of trial; date of disclosure
(A) In general
In the case of information regarding a clinical trial that is contained in the data bank pursuant to subsection (d)(2), disclosures required in paragraph (5) shall begin promptly after the information is submitted to the Secretary, subject to subparagraph (B). (... |
108hr5252ih | (f) Determination of violations
(1) Compliance audits
(A) In general
The Secretary shall conduct periodic audits of responsible persons for clinical trials receiving awards described in subsection (a)(1) in order to determine whether the persons have submitted information as required under agreements under subparagr... |
108hr5252ih | (B) Priority
In conducting audits under subparagraph (A), the Secretary shall give priority to responsible persons for clinical trials who have at any time been included on the list under subsection (g)(1)(A)(i), taking into account the number and severity of the violations involved. (2) Notice to responsible persons ... |
108hr5252ih | (g) Actions of Secretary regarding violations
(1) In general
If a responsible person for a clinical trial is in violation of an agreement under subparagraph (A) or (B) of subsection (a)(1) (including submitting information under such a subparagraph that is false or misleading), the following applies, |
108hr5252ih | subject to paragraph (4) of this subsection: (A) In any case in which the violation is not corrected within 30 days after the Secretary provides to the responsible person a notice under subsection (f)(2) regarding the violation: (i) Through Internet sites under subsection (e)(3) and such other means as the Secretary de... |
108hr5252ih | (ii) The responsible person is, pursuant to subsection (a)(1)(D), subject to a liquidated penalty of not more than a total of $15,000 for all violations adjudicated in a single proceeding in the case of an individual, and $10,000 per day until the violation is corrected in the case of any other person, except that if t... |
108hr5252ih | Paragraphs (3) through (5) of section 303(f) of the Federal Food, Drug, and Cosmetic Act apply to the imposition of such a penalty to the same extent and in the same manner as such paragraphs apply to a penalty imposed under paragraph (1) or (2) of such section. |
108hr5252ih | (B) In any case in which the violation is a significant violation and is not corrected within 60 days after the Secretary provides to the responsible person a notice under subsection (f)(2) regarding the violation, the Secretary shall, after notice and an opportunity for a hearing, consider the person to be ineligible ... |
108hr5252ih | (C) In any case in which the violation is a failure to submit to the data bank the results of the trial by the due date under subsection (d)(2)(A)(i), the Secretary shall order the responsible person to submit to the data bank periodic reports on the progress being made toward submission of the results, which reports s... |
108hr5252ih | (2) Relation to related requirements
If a responsible person for a clinical trial is ineligible for purposes of section 565(f)(1)(B) or 566(a)(2) of the Federal Food, Drug, and Cosmetic Act, the person is ineligible for any award described in subsection (a)(1) during the period of such ineligibility, without regard to... |
108hr5252ih | (3) False or misleading information
If the Secretary determines that the responsible person for a clinical trial has submitted to the data bank information that is false or misleading, and if on such basis a civil money has been imposed under paragraph (1)(A)(ii) on such person or the person has becomes ineligible wit... |
108hr5252ih | (4) Waiver regarding ineligibility for funding
With respect to a responsible person who is ineligible for purposes of paragraph (1)(B) or (2), the Secretary may waive the applicability of such paragraph in order to provide for a clinical trial if the Secretary determines that providing the waiver is in the public inte... |
108hr5252ih | (5) Funding of comparative studies
Penalties collected by the Secretary under paragraph (1)(A)(ii) shall be used by the Secretary to make awards of grants, contracts, or cooperative agreements for the conduct of comparative clinical trials to determine the safety or relative effectiveness of products. (h) Criteria
Th... |
108hr5252ih | (i) Award for conduct of clinical trial; compliance costs as direct costs
In administering an award of a grant, contract, or cooperative agreement that is subject to subsection (a)(1), the Secretary shall consider the costs of complying with requirements under such subsection as part of the direct costs of conducting ... |
108hr5252ih | (2) The term approved use , with respect to an approved product, means a use that is an approved, licensed, or cleared use of the product under a provision of law referred to in paragraph (1). |
108hr5252ih | (3) The term clinical trial , with respect to a product, means a clinical investigation within the meaning of section 505(i) of the Federal Food, Drug, and Cosmetic Act (in the case of drug), or within the meaning of section 520(g) of such Act (in the case of a device), as applicable, except that such term does not inc... |
108hr5252ih | (5) The term device has the meaning given such term in section 201(h) of the Federal Food, Drug, and Cosmetic Act. (6) The term drug has the meaning given such term in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act. Such term includes a biological product. (7) The term MEDLINE means the bibliographic ele... |
108hr5252ih | (8) The term product has the meaning indicated for such term in subsection (a)(1). (9) The term researchers means individuals who conduct research on drugs or devices. |
108hr5252ih | (10) The term responsible person , with respect to a clinical trial to determine the safety or effectiveness of a use of a product, has the following meaning, as applicable: (A) In any case in which an application has been submitted for an exemption under section 505(i) or 520(g)(2)(A) with respect to the trial, such t... |
108hr5252ih | (B) In any case in which such an application has not been submitted, such term means the entity who is or will be providing the largest share of the monetary support for the trial (without regard to any in-kind support for the trial), subject to the following: (i) If the Federal Government or a State is or will be prov... |
108hr5252ih | (ii) If a nonprofit private entity is or will be providing the largest share, such term means the principal investigator for the trial in any case in which such entity and investigator have jointly certified to the Secretary that the investigator will be the responsible person for purposes of this section. (iii) If two... |
108hr5252ih | (iv) Notwithstanding clauses (i) through (iii), if an entity submits to the Secretary a written request to be the responsible person for purposes of this section, such term means that entity in any case in which the Secretary determines that the entity is or will be providing monetary support for the trial and is respo... |
108hr5252ih | (k) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for fiscal year 2004 and each subsequent fiscal year. Fees collected under section 736 or 738 of the Federal Food, Drug, and Cosmetic Act shall not be used in carrying... |
108hr5252ih | is amended by adding at the end the following section: 565. Investigational drugs and devices; conditions regarding data bank on clinical trials
(a) In general
(1) Conditions for exemptions
Except as provided in paragraph (2), an exemption under section 505(i) or 520(g)(2)(A) for an investigation to determine the sa... |
108hr5252ih | (B) the sponsor of the investigation agrees to provide to the Secretary information on the results of the investigation; and (C) the sponsor of the investigation agrees to the disclosure to the public of information regarding the investigation. (2) Exception
Paragraph (1) does not apply to an investigation to determin... |
108hr5252ih | (b) Institutional review boards
For purposes of subsection (a), the Secretary shall amend parts 50, 56, and 812 of title 21, Code of Federal Regulations, to provide that— (1) the functions of institutional review boards under such parts include— (A) determining whether investigations are registered under subsection (a... |
108hr5252ih | and (3) upon request of an institutional review board for such an investigation, the Secretary will provide to the board a copy of the registration for the investigation under such subsection (which copy will be the registration as submitted to the Secretary, together with all updates to the registration). (c) Certain ... |
108hr5252ih | The reference in such subsection to an exemption under section 520(g)(2)(A) includes an exemption described in section 812.2(b) of such title 21. |
108hr5252ih | (d) Relationship to similar requirements
For purposes of subsection (a): (1) The responsibilities of a sponsor of an investigation, and of the Secretary, are the same as apply under section 491A of the Public Health Service Act with respect to responsible persons, except to the extent of taking into account that this ... |
108hr5252ih | (2) The Secretary shall administer the program under this section and the program under section 491A of such Act as substantially a single program, shall not require duplicative registrations, and shall otherwise avoid duplicative activities. |
108hr5252ih | (e) Determination of violations
(1) Compliance audits
(A) In general
The Secretary shall conduct periodic audits of sponsors of investigations for which exemptions referred to in subsection (a)(1) are in effect in order to determine whether the sponsors have submitted information as required under agreements under s... |
108hr5252ih | (B) Priority
In conducting audits under subparagraph (A), the Secretary shall give priority to sponsors of investigations who have at any time been included on the list under subsection (f)(1)(A)(i), taking into account the number and severity of the violations involved. (2) Notice to sponsors
Promptly after determin... |
108hr5252ih | (f) Actions of secretary regarding violations
(1) In general
If a sponsor of an investigation is in violation of an agreement under subparagraph (A) or (B) of subsection (a)(1) (including submitting information under such a subparagraph that is false or misleading), the following applies, |
108hr5252ih | subject to paragraph (2) of this subsection: (A) In any case in which the violation is not corrected within 30 days after the Secretary provides to the sponsor a notice under subsection (e)(2) regarding the violation: (i) Through Internet sites operated pursuant to subsection (d) and such other means as the Secretary d... |
108hr5252ih | (ii) The sponsor is subject to a civil penalty of not more than a total of $15,000 for all violations adjudicated in a single proceeding in the case of an individual, and $10,000 per day until the violation is corrected in the case of any other person, except that if the person is a nonprofit entity the penalty may not... |
108hr5252ih | Paragraphs (3) through (5) of section 303(f) apply to the imposition of such a penalty to the same extent and in the same manner as such paragraphs apply to a penalty imposed under paragraph (1) or (2) of such section. |
108hr5252ih | (B) In any case in which the violation is a significant violation and is not corrected within 60 days after the Secretary provides to the sponsor a notice under subsection (e)(2) regarding the violation, the Secretary may, after notice and an opportunity for a hearing, consider the sponsor to be ineligible for any futu... |
108hr5252ih | (C) In any case in which the violation is a failure to submit to the data bank the results of the investigation by the due date that applies pursuant to subsection (d), the Secretary shall order the sponsor of the investigation to submit to the data bank periodic reports on the progress being made toward submission of ... |
108hr5252ih | (2) False or misleading information
If the Secretary determines that the sponsor of an investigation has submitted to the data bank information that is false or misleading, and if on such basis a civil money has been imposed under paragraph (1)(A)(ii) on the sponsor or the sponsor has becomes ineligible within the mea... |
108hr5252ih | (3) Waiver regarding ineligibility for exemptions
With respect to a sponsor who is ineligible for purposes of paragraph (1)(B), the Secretary may waive the applicability of such paragraph in order to provide for an investigation if the Secretary determines that providing the waiver is in the public interest or consist... |
108hr5252ih | (4) Funding of comparative studies
Penalties collected by the Secretary under paragraph (1)(A)(ii) shall be used by the Secretary to make awards of grants or contracts for the conduct of comparative investigations to determine the safety or relative effectiveness of products. (g) Definitions
(1) In general
Definitio... |
108hr5252ih | (2) Investigation
For purposes of this section, the term investigation means a clinical investigation within the meaning of section 505(i) (in the case of drug), or within the meaning of section 520(g) (in the case of a device), as applicable, except that such term does not include such an investigation that does not ... |
108hr5252ih | is amended— (A) in section 505(i), by adding at the end the following paragraph: (5) The provision of an exemption under paragraph (1) is subject to section 565 (relating to information on investigations). |
108hr5252ih | ; and (B) in section 520(g), by adding at the end the following paragraph: (8) The provision of an exemption under paragraph (2)(A) is subject to section 565 (relating to information on investigations).. (b) Premarket application or report; labeling and advertising
Subchapter E of chapter V of the Federal Food, Drug, ... |
108hr5252ih | relation to data bank on clinical trials
(a) Premarket application or report
If a person submits to the Secretary an application under section 505(b) or 515 or a report under section 510(k), and one or more of the investigations presented to the Secretary by the person for purposes of the application or report are in... |
108hr5252ih | the following applies: (1) The person is subject to a civil penalty— (A) in any case in which information on the investigation has not, as of the date on which the application or report is submitted to the Secretary, been submitted to the data bank described in such section 491A to the same extent as would have been re... |
108hr5252ih | information on the investigation is not submitted to the data bank to the same extent as would be required if the investigation were subject to such requirements. |
108hr5252ih | (2) If the person is subject to a civil penalty under paragraph (1), the Secretary, in addition to such penalty, may, after notice and an opportunity for a hearing, consider the person to be ineligible for any future exemptions under section 505(i) or 520(g)(2)(A) for any investigation until the information involved is... |
108hr5252ih | or an advertisement or other descriptive printed matter, for a drug or device for human use and the labeling, advertisement, or other matter refers to an investigation that is not subject to requirements under section 565 or under section 491A of the Public Health Service, and if the person was the principal investigat... |
108hr5252ih | been submitted to the data bank described in such section 491A to the same extent as would have been required as of such date if the investigation had been subject to such requirements (without regard to timeframes for the submission of information that would have applied before such date under such section); and (2) i... |
108hr5252ih | (c) Amount of civil penalty; procedure
A civil penalty under subsection (a)(1) or (b) shall be not more than a total of $15,000 for all violations adjudicated in a single proceeding in the case of an individual, and $10,000 per day until the violation is corrected in the case of any other person, except that if the pe... |
108hr5252ih | Paragraphs (3) through (5) of section 303(f) apply to the imposition of such a penalty to the same extent and in the same manner as such paragraphs apply to a penalty imposed under paragraph (1) or (2) of such section. (d) Biologics license application
Subsections (a) and (c) apply with respect to a biologics license ... |
108hr5252ih | (e) Definitions
For purposes of this section: (1) The term investigation has the meaning given such term in section 565(g). (2) The term responsible person has the meaning given such term in section 491A(j) of the Public Health Service Act. (c) Clinical investigations in progress
With respect to a clinical investigat... |
108hr5252ih | and if the investigation is one for which an exemption under section 505(i) or 520(g)(2)(A) of the Federal Food, Drug, and Cosmetic Act is in effect, the investigation becomes subject to section 565 of such Act (as added by subsection (a) of this section) upon the expiration of 30 days after the date of the enactment o... |
108hr5252ih | For purposes of the preceding sentence, the term clinical investigation has the meaning given such term in subsection (g)(2) of such section 565. 565. Investigational drugs and devices; conditions regarding data bank on clinical trials
(a) In general
(1) Conditions for exemptions
Except as provided in paragraph (2), |
108hr5252ih | an exemption under section 505(i) or 520(g)(2)(A) for an investigation to determine the safety or effectiveness of the use of a drug or device (referred to in this section as a product ) may not be considered to be in effect unless— (A) the sponsor of the investigation agrees to register the investigation with the Secr... |
108hr5252ih | (2) Exception
Paragraph (1) does not apply to an investigation to determine the safety of a use of a drug if the trial is designed solely to detect major toxicities in the drug or to investigate pharmacokinetics, except that such paragraph does apply if the trial is designed solely to investigate pharmacokinetics in a... |
108hr5252ih | to provide that— (1) the functions of institutional review boards under such parts include— (A) determining whether investigations are registered under subsection (a)(1)(A); and (B) denying the approval of the boards for investigations that are not registered under such subsection; (2) any approval of an institutional ... |
108hr5252ih | the Secretary will provide to the board a copy of the registration for the investigation under such subsection (which copy will be the registration as submitted to the Secretary, together with all updates to the registration). (c) Certain exemptions
The reference in subsection (a) to an exemption under section 505(i) ... |
108hr5252ih | (d) Relationship to similar requirements
For purposes of subsection (a): (1) The responsibilities of a sponsor of an investigation, and of the Secretary, are the same as apply under section 491A of the Public Health Service Act with respect to responsible persons, except to the extent of taking into account that this ... |
108hr5252ih | (2) The Secretary shall administer the program under this section and the program under section 491A of such Act as substantially a single program, shall not require duplicative registrations, and shall otherwise avoid duplicative activities. |
108hr5252ih | (e) Determination of violations
(1) Compliance audits
(A) In general
The Secretary shall conduct periodic audits of sponsors of investigations for which exemptions referred to in subsection (a)(1) are in effect in order to determine whether the sponsors have submitted information as required under agreements under s... |
108hr5252ih | (B) Priority
In conducting audits under subparagraph (A), the Secretary shall give priority to sponsors of investigations who have at any time been included on the list under subsection (f)(1)(A)(i), taking into account the number and severity of the violations involved. (2) Notice to sponsors
Promptly after determin... |
108hr5252ih | (f) Actions of secretary regarding violations
(1) In general
If a sponsor of an investigation is in violation of an agreement under subparagraph (A) or (B) of subsection (a)(1) (including submitting information under such a subparagraph that is false or misleading), the following applies, |
108hr5252ih | subject to paragraph (2) of this subsection: (A) In any case in which the violation is not corrected within 30 days after the Secretary provides to the sponsor a notice under subsection (e)(2) regarding the violation: (i) Through Internet sites operated pursuant to subsection (d) and such other means as the Secretary d... |
108hr5252ih | (ii) The sponsor is subject to a civil penalty of not more than a total of $15,000 for all violations adjudicated in a single proceeding in the case of an individual, and $10,000 per day until the violation is corrected in the case of any other person, except that if the person is a nonprofit entity the penalty may not... |
108hr5252ih | Paragraphs (3) through (5) of section 303(f) apply to the imposition of such a penalty to the same extent and in the same manner as such paragraphs apply to a penalty imposed under paragraph (1) or (2) of such section. |
108hr5252ih | (B) In any case in which the violation is a significant violation and is not corrected within 60 days after the Secretary provides to the sponsor a notice under subsection (e)(2) regarding the violation, the Secretary may, after notice and an opportunity for a hearing, consider the sponsor to be ineligible for any futu... |
108hr5252ih | (C) In any case in which the violation is a failure to submit to the data bank the results of the investigation by the due date that applies pursuant to subsection (d), the Secretary shall order the sponsor of the investigation to submit to the data bank periodic reports on the progress being made toward submission of ... |
108hr5252ih | (2) False or misleading information
If the Secretary determines that the sponsor of an investigation has submitted to the data bank information that is false or misleading, and if on such basis a civil money has been imposed under paragraph (1)(A)(ii) on the sponsor or the sponsor has becomes ineligible within the mea... |
108hr5252ih | (3) Waiver regarding ineligibility for exemptions
With respect to a sponsor who is ineligible for purposes of paragraph (1)(B), the Secretary may waive the applicability of such paragraph in order to provide for an investigation if the Secretary determines that providing the waiver is in the public interest or consist... |
108hr5252ih | (4) Funding of comparative studies
Penalties collected by the Secretary under paragraph (1)(A)(ii) shall be used by the Secretary to make awards of grants or contracts for the conduct of comparative investigations to determine the safety or relative effectiveness of products. (g) Definitions
(1) In general
Definitio... |
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