Sec. 102. Research protocols
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Paragraph (2)(B) of section 303 of the Controlled Substances Act ( 21 U.S.C. 823(f) ), as amended by section 101 of this Act, is further amended by adding at the end the following: If the Attorney General grants an application for registration under clause (i), the registrant may amend or supplement the research protocol without reapplying if the registrant does not change— the quantity or type of drug; the source of the drug; or the conditions under which the drug is stored, tracked, or administered. If a registrant under clause
(i)seeks to change the type of drug, the source of the drug, or conditions under which the drug is stored, tracked, or administered, the registrant shall notify the Attorney General via registered mail, or an electronic means permitted by the Attorney General, not later than 30 days before implementing an amended or supplemental research protocol. A registrant may proceed with an amended or supplemental research protocol described in item
(aa)if the Attorney General does not explicitly object during the 30-day period beginning on the date on which the Attorney General receives the notice under item (aa). The Attorney General may only object to an amended or supplemental research protocol under this subclause if additional security measures are needed to safeguard against diversion or abuse. If a registrant under clause
(i)seeks to address additional security measures identified by the Attorney General under item (cc), the registrant shall notify the Attorney General via registered mail, or an electronic means permitted by the Attorney General, not later than 30 days before implementing an amended or supplemental research protocol. A registrant may proceed with an amended or supplemental research protocol described in item
(dd)if the Attorney General does not explicitly object during the 30-day period beginning on the date on which the Attorney General receives the notice under item (dd). If a registrant under clause
(i)seeks to change the quantity of marihuana needed for research, the change shall be deemed approved by the Attorney General on the date on which the registered mail return receipt is returned to the registrant, or the date on which the electronic notification, as permitted by the Attorney General, is received, if the registrant submits to the Attorney General— the Drug Enforcement Administration registration number of the registrant; the quantity of marihuana already obtained; and the quantity of additional marihuana needed to complete the research. Nothing in this clause shall limit the authority of the Secretary of Health and Human Services over requirements related to research protocols, including changes in— the method of administration of marihuana; the dosing of marihuana; and the number of individuals or patients involved in research. . Not later than 1 year after the date of enactment of this Act, the Attorney General shall promulgate regulations to carry out the amendment made by this section.
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Sec. 102
Research protocols
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