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Federal Register / Vol. 86, No. 211 / Thursday, November 4, 2021 / Proposed Rules Similar to 123Iioflupane, 18FFP-CIT
was developed for diagnostic purposes and contains a small amount of the API.
The amount of 18FFP-CIT in each vial of 18FFP-CIT would be limited and it is produced based on demand.
Additional regulations and control mechanisms by the NRC and other federal agencies exist for the production, handling and use of 18FFP-CIT due to its radioactivity.
5. The Scope, Duration, and Significance of Abuse DEA has searched the scientific literature and the Federal, State, and local forensic laboratory databases such as NFLIS to assess the scope of 18FFPCIT abuse in the United States. There were no reports of 18FFP-CIT seizures during the period of January 2010April 2021.
6. What, if Any, Risk There Is to the Public Health The risk to public health is unknown for 18FFP-CIT. However, as stated by HHS the radioactive nature of the substance, limited amounts of substance needed for imaging purposes, and the existence of stringent regulatory controls on the manufacturing and handling, 18FFP-CIT poses little or no practical risk to public health. Because the API for 18FFP-CIT is the same as 123Iioflupane, 18FFP-CIT is expected to have the same product characteristics.
7. Its Psychic or Physiological Dependence Liability HHS reports that no systemic evaluation has been conducted to determine whether 123Iioflupane or 18FFP-CIT produces psychic or physiological dependence in animals or humans. It is expected that the use of the radiolabeled agents i.e., 123Iioflupane and 18FFP-CIT will not produce psychic or physiological dependence due to the low dose and short-term exposure.

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8. Whether the Substance Is an Immediate Precursor of a Substance Already Controlled Under the CSA
Similar to 123Iioflupane, 18FFP-CIT
is not an immediate precursor of a substance already controlled under the CSA.
Conclusion Based on consideration of the scientific and medical evaluation and accompanying recommendation of HHS, and based on DEAs consideration of its own eight-factor analysis, DEA finds that these facts and all relevant data demonstrate that 18FFP-CIT does not
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possess abuse or dependence potential.
According to HHS, no NDA containing 18FFP-CIT has been submitted.
However, the finding that 18FFP-CIT
lacks abuse potential would, irrespective of other findings, permit decontrol of 18FFP-CIT prior to or in the absence of an FDA action under 21
U.S.C. 355c. Accordingly, DEA finds that 18FFP-CIT does not meet the requirements for inclusion in any schedule, and should be removed from control under the CSA.
Regulatory Analyses Executive Orders 12866 Regulatory Planning and Review and 13563
Improving Regulation and Regulatory Review In accordance with 21 U.S.C. 811a, this scheduling action is subject to formal rulemaking procedures done on the record after opportunity for a hearing, which are conducted pursuant to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the criteria for removing a drug or other substance from the list of controlled substances. Such actions are exempt from review by Office of Management and Budget pursuant to section 3d1 of Executive Order E.O. 12866 and the principles reaffirmed in E.O. 13563.
Executive Order 12988, Civil Justice Reform This proposed regulation meets the applicable standards set forth in sections 3a and 3b2 of E.O. 12988
Civil Justice Reform to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.
Executive Order 13132, Federalism This rulemaking does not have federalism implications warranting the application of E.O. 13132. The proposed rule does not have substantial direct effects on the States, on the relationship between the Federal Government and the States, or the distribution of power and responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal Governments This proposed rule does not have tribal implications warranting the application of E.O. 13175. This proposed rule does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.

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Regulatory Flexibility Act The Administrator, in accordance with the Regulatory Flexibility Act 5
U.S.C. 601612, has reviewed this proposed rule and by approving it certifies that it will not have a significant economic impact on a substantial number of small entities.
The purpose of this proposed rule is to remove 18FFP-CIT from the list of schedules of the CSA. This action will remove regulatory controls and administrative, civil, and criminal sanctions applicable to controlled substances for handlers and proposed handlers of 18FFP-CIT. Accordingly, it has the potential for some economic impact in the form of cost savings.
If finalized, the proposed rule will affect all persons who would handle, or propose to handle 18FFP-CIT. 18FFPCIT is not currently available or marketed in any country. Due to the wide variety of unidentifiable and unquantifiable variables that potentially could influence the distribution and dispensing rates, if any, of 18FFP-CIT, DEA is unable to determine the number of entities and small entities which might handle 18FFP-CIT. In some instances where a controlled pharmaceutical drug is removed from the schedules of the CSA, DEA is able to quantify the estimated number of affected entities and small entities because the handling of the drug is expected to be limited to DEA
registrants even after removal from the schedules. In such instances, DEAs knowledge of its registrant population forms the basis for estimating the number of affected entities and small entities. However, DEA does not have a basis to estimate whether 18FFP-CIT is expected to be handled by persons who hold DEA registrations, by persons who are not currently registered with DEA to handle controlled substances, or both.
Therefore, DEA is unable to estimate the number of entities and small entities who plan to handle 18FFP-CIT.
Although DEA does not have a reliable basis to estimate the number of affected entities and quantify the economic impact of this proposed rule, a qualitative analysis indicates that this rule is likely to result in some cost savings. As noted above, DEA is specifically soliciting comments on the economic impact of this proposed rule.
DEA will revise this section if warranted after consideration of any comments received. Any person planning to handle 18FFP-CIT will realize cost savings in the form of saved DEA
registration fees, and the elimination of physical security, recordkeeping, and reporting requirements.

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