Sec. 102. Research protocols
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Paragraph (2)(B) of section 303(f) 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 and the change in quantity does not impact the factors described in item
(bb)or
(cc)of subclause
(I)of this clause, the registrant shall notify the Attorney General via registered mail or using an electronic means permitted by the Attorney General. A notification under item
(aa)shall include— the Drug Enforcement Administration registration number of the registrant; the quantity of marihuana already obtained; the quantity of additional marihuana needed to complete the research; and an attestation that the change in quantity does not impact the source of the drug or the conditions under which the drug is stored, tracked, or administered. The Attorney General shall ensure that— any registered mail return receipt with respect to a notification under item
(aa)is submitted for delivery to the registrant providing the notification not later than 3 days after receipt of the notification by the Attorney General; and notice of receipt of a notification using an electronic means permitted under item
(aa)is provided to the registrant providing the notification not later than 3 days after receipt of the notification by the Attorney General. On and after the date described in subitem (BB), a registrant that submits a notification in accordance with item
(aa)may proceed with the research as if the change in quantity has been approved on such date, unless the Attorney General notifies the registrant of an objection described in item (ee). The date described in this subitem is the date on which a registrant submitting a notification under item
(aa)receives the registered mail return receipt with respect to the notification or the date on which the registrant receives notice that the notification using an electronic means permitted under item
(aa)was received by the Attorney General, as the case may be. A notification submitted under item
(aa)shall be deemed to be approved unless the Attorney General, not later than 10 days after receiving the notification, explicitly objects based on a finding that the change in quantity— does impact the source of the drug or the conditions under which the drug is stored, tracked, or administered; or necessitates that the registrant implement additional security measures to safeguard against diversion or abuse. 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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