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Federal Register / Vol. 86, No. 211 / Thursday, November 4, 2021 / Proposed Rules
lotter on DSK11XQN23PROD with PROPOSALS1

of any interested party. 21 U.S.C. 811a.
This action was initiated by a petition to remove 18FFP-CIT from the list of scheduled controlled substances of the CSA, and is supported by, inter alia, a recommendation from the Assistant Secretary for Health of HHS and an evaluation of all relevant data by DEA.
If finalized, this action would remove the regulatory controls and administrative, civil, and criminal sanctions applicable to controlled substances, including those specific to schedule II controlled substances, on persons who handle or propose to handle 18FFP-CIT.
Background 18FFP-CIT chemical names: 18FNw-fluoropropyl-b-CIT; fluorine-18-N-3fluoropropyl-2-beta-carbomethoxy-3beta-4-iodophenyltropane;
18Ffluoropropylcarbomethoxy nortropane is described as a diagnostic substance that is used in assisting the evaluation of adult patients with suspected Parkinsonian syndromes. It is an entity used in the visualization of striatal dopamine transporters DAT
using positron emission tomography PET imaging. 18FFP-CIT is not yet approved by the United States Food and Drug Administration FDA and no New Drug Application NDA for 18FFP-CIT
or any 18FFP-CIT-containing drug has been submitted to FDA.
18FFP-CIT is structurally similar to 123
Iioflupane, known as DaTscan or 123IFP-CIT. Both 18FFP-CIT and 123Iioflupane were developed as clinical diagnostic substances to visualize DAT and contain the same tracer amount of the precursor, ecgonine. The only difference between these two compounds is the radiotracer 123I versus 18F. On January 14, 2011, FDA approved the NDA for 123Iioflupane-containing drug product, DaTscan, for use to visualize striatal DAT in the brains of adult patients with suspected Parkinsonian syndromes using single photon emission computed tomography SPECT imaging. DEA
removed 123Iioflupane from schedule II of the CSA on September 11, 2015 80
FR 54715.
The starting material for the synthesis of 18FFP-CIT and 123Iioflupane is Nnor-b-CIT 2b-carbomethoxy-3b -4iodophenyl nortropane, which is derived from cocaine, a schedule II
substance, via ecgonine a schedule II
substance. Thus, by definition 18FFPCIT is a schedule II controlled substance under the CSA. On June 28, 2018, DEA
received a petition from Advanced domestic drug scheduling recommendations. 58 FR
35460, July 1, 1993.

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Imaging Projects to initiate proceedings to amend 21 CFR 1308.12b4 so as to decontrol 18FFP-CIT proposed tradename Fluoroseek from schedule II
of the CSA. On October 6, 2018 and November 6, 2018, DEA received supplemental information from the Petitioner; DEA accepted the petition on November 28, 2018.
Proposed Determination To Decontrol 18FFP-CIT
Pursuant to 21 U.S.C. 811b, on May 2, 2019, DEA, having gathered the necessary data on 18FFP-CIT, forwarded that data and the petition to HHS with a request for scientific and medical evaluation and scheduling recommendation for 18FFP-CIT. On April 16, 2021, DEA received from HHS
a scientific and medical evaluation conducted by FDA entitled Basis for the recommendation to remove 18FFPCIT from schedule II of the Controlled Substances Act and a scheduling recommendation. The National Institute on Drug Abuse NIDA concurred with the scientific and medical evaluation conducted by FDA. Based on the totality of the available scientific data, 18FFPCIT does not conform with the findings for schedule II in 21 U.S.C. 812b2 or in any other schedule as set forth in 21
U.S.C. 812b. Based on FDAs scientific and medical review of the eight factors and findings related to the substances abuse potential, legitimate medical use, and dependence liability, HHS
recommended that 18FFP-CIT be removed from all schedules of the CSA.
The CSA requires DEA, as delegated by the Attorney General,2 to determine whether HHSs scientific and medical evaluation, scheduling recommendation, and all other relevant data constitute substantial evidence that a substance should be scheduled. 21
U.S.C. 811b. DEA reviewed the scientific and medical evaluation and scheduling recommendation provided by HHS, and all other relevant data, and completed its own eight-factor review document on 18FFP-CIT pursuant to 21
U.S.C. 811c. Included below is a brief summary of each factor as analyzed by HHS and DEA, and as considered by DEA in this proposal to remove 18FFPCIT from the schedules of the CSA. Both DEA and HHS analyses are available in their entirety under Supporting and Related Material of the public docket for this rule at http
www.regulations.gov under docket number DEA837.
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1. The Drugs Actual or Relative Potential for Abuse The first factor that must be considered is the actual or relative potential for abuse of 18FFP-CIT. The term abuse is not defined in the CSA.
However, the legislative history of the CSA suggests the following points in determining whether a particular drug or substance has a potential for abuse: 3
a. Whether there is evidence that individuals are taking the drug or drugs containing such a substance in amounts sufficient to create a hazard to their health or to the safety of other individuals or to the community.
According to HHSs scientific and medical evaluation, there are no data demonstrating that individuals are taking either 18FFP-CIT or 123Iioflupane in amounts sufficient to create a hazard to their health or to the safety of other individuals or to the community. Additionally, as reported in the 123Iioflupane HHS review, no case reports or clinical trials were published in scientific or medical literature that describe any incidents of drug abuse, misuse, or diversion of 123Iioflupane.
HHS notes that in their assessment of the abuse potential of 123Iioflupane from studies conducted in animals, it was estimated that doses of the radiolabeled FP-CIT in the milligram range would be needed to elicit stimulant effects. Since the active pharmaceutical ingredient API is the same, the same calculations apply to 18FFP-CIT. HHS further states that upon receiving prescriptions from physicians 18FFP-CIT will be manufactured immediately prior to its shipment and its limited availability will make its abuse logistically not possible.
b. Whether there is significant diversion of the drug or drugs containing such a substance from legitimate drug channels.
There has been no demonstrated diversion of 123Iioflupane or 18FFPCIT. According to DEAs forensic laboratory databases, the National Forensic Laboratory Information System NFLIS,4 there are no cases of 123Iioflupane or 18FFP-CIT queried May 27, 2021. Further, according to data assessed for 123Iioflupane, it is highly unlikely that 18FFP-CIT or 18FFP-CIT-containing products will be diverted in the United States. In the 3 Comprehensive Drug Abuse Prevention and Control Act of 1970, H.R. Rep. No. 911444, 91st Cong., Sess. 1 1970; 1970 U.S.C.C.A.N. 4566, 4603.
4 NFLIS is a national forensic laboratory reporting system that systematically collects results from drug chemistry analyses conducted by State and local forensic laboratories in the United States.

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