Sec. 9. Compliance activities reports
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In this section: The term applicable clinical trial has the meaning given the term in section 402(j) of the Public Health Service Act ( 42 U.S.C. 282(j) ). The term Director of NIH means the Director of the National Institutes of Health. The term Secretary means the Secretary of Health and Human Services. Not later than 2 years after the date of enactment of this Act, the Secretary, acting through the Director of NIH and in collaboration with the Commissioner of Food and Drugs, shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report that describes education and outreach, guidance, enforcement, and other activities undertaken to encourage compliance with section 402(j) of the Public Health Service Act ( 42 U.S.C. 282(j) ).
Not later than 2 years after the final compliance date under the final rule implementing section 402(j) of the Public Health Service Act, and every 2 years thereafter for the next 4 years, the Secretary, acting through the Director of NIH and in collaboration with the Commissioner of Food and Drugs, shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report describing— the total number of applicable clinical trials with complete data bank registration information registered during the period for which the report is being prepared (broken down by each year of such reporting period); the total number of applicable clinical trials registered during the period for which the report is being prepared for which results have been submitted to the data bank (broken down by each year of such reporting period); the activities undertaken by the Secretary during the period for which the report is being prepared to educate responsible persons about data bank registration and results submission requirements, including through issuance of guidance documents, informational meetings, and training sessions; and the activities described in the report submitted under subsection (b).
After the Secretary has undertaken the educational activities described in paragraph (1)(C), the Secretary shall include in subsequent reports submitted under paragraph
(1)the number of actions taken by the Secretary during the period for which the report is being prepared to enforce compliance with data bank registration and results submission requirements.
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Sec. 9
Compliance activities reports
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