51234 Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Rules and Regulations will no longer meet or medically equal the medulloblastoma or other primitive Propofol has been available for medical criteria of a listing in this body system. neuroectodermal tumors (PNETs) with use in the United States since 1989 and 3. * * * If you have a recurrence or relapse documented metastases, grades III and IV is not currently a controlled substance. of your malignancy, your impairment may astrocytomas, glioblastoma multiforme, The pharmacological effects of meet or medically equal one of the listings ependymoblastoma, diffuse intrinsic brain fospropofol are attributed to the in this body system again. stem gliomas, or primary sarcomas. pharmacological actions of propofol. * * * * * * * * * * Propofol binds to g-aminobutyric acid I. What do we mean by the following [FR Doc. E9–23896 Filed 10–5–09; 8:45 am] terms? (GABAA) receptor and acts as a 1. Metastases: The spread of tumor cells by BILLING CODE 4191–02–P modulator by potentiating the activity of blood, lymph, or other body fluid. This term GABA at this receptor. does not include the spread of tumor cells by Since propofol is the active metabolite direct extension of the tumor to other tissue DEPARTMENT OF JUSTICE of fospropofol, the abuse potential of or organs. fospropofol is comparable to that of 2. Multimodal therapy: A combination of at Drug Enforcement Administration propofol. Animal self-administration least two types of treatment modalities given studies demonstrated that the in close proximity as a unified whole and 21 CFR Part 1308 reinforcing effects of propofol are usually planned before any treatment has relatively low and comparable to begun. There are three types of treatment [Docket No. DEA–327F] modalities: Surgery, radiation, and systemic midazolam and other schedule IV drug therapy (chemotherapy, hormonal Schedules of Controlled Substances; benzodiazepines. Fospropofol elicits therapy, and immunotherapy). Examples of Placement of Fospropofol Into behavioral effects similar to multimodal therapy include: Schedule IV methohexital and midazolam, schedule a. Surgery followed by chemotherapy or IV sedative-hypnotics. radiation. AGENCY: Drug Enforcement Since fospropofol is a new molecular b. Chemotherapy followed by surgery. Administration, Department of Justice. entity, there has been no evidence of c. Chemotherapy and concurrent radiation. ACTION: Final rule. diversion, abuse, or law enforcement 3. Persistent: Failure to achieve a complete encounters involving the drug. remission. SUMMARY: With the issuance of this final On February 27, 2009, the Acting 4. Progressive: The malignancy becomes rule, the Deputy Administrator of the Assistant Secretary for Health, more extensive despite treatment. Drug Enforcement Administration 5. Recurrent, relapse: A malignancy that Department of Health and Human was in complete remission or entirely (DEA) places the substance fospropofol, Services (DHHS), sent the Deputy removed by surgery has returned. including its salts, isomers and salts of Administrator of DEA a scientific and isomers whenever the existence of such * * * * * medical evaluation and a letter K. How do we evaluate specific malignant salts, isomers, and salts of isomers is recommending that fospropofol be neoplastic diseases? possible, into schedule IV of the placed into schedule IV of the CSA. 1. Lymphoma. Controlled Substances Act (CSA). As a Enclosed with the February 27, 2009, a. We provide criteria for evaluating result of this rule, the regulatory letter was a document prepared by the aggressive lymphomas that have not controls and criminal sanctions of FDA entitled, ‘‘Basis for the responded to antineoplastic therapy in schedule IV will be applicable to the Recommendation for Control of 113.05. Indolent (non-aggressive) lymphomas manufacture, distribution, dispensing, Fospropofol and Its Salts in Schedule IV are rare in children. We will evaluate importation, and exportation of of the Controlled Substances Act indolent lymphomas in children under 13.05 fospropofol and products containing in part A. (CSA).’’ The document contained a fospropofol. review of the factors which the CSA * * * * * requires the Secretary to consider 2. Leukemia. DATES: Effective Date: November 5, a. Acute leukemia. * * * Recurrent disease 2009. (21 U.S.C. 811(b)). must be documented by peripheral blood, After a review of the available data, FOR FURTHER INFORMATION CONTACT: including the scientific and medical bone marrow, or cerebrospinal fluid Christine A. Sannerud, PhD, Chief, Drug examination, or by testicular biopsy. * * * evaluation and the scheduling and Chemical Evaluation Section, Office * * * * * recommendation from DHHS, the of Diversion Control, Drug Enforcement Deputy Administrator of the DEA 4. Brain tumors. We use the criteria in Administration, 8701 Morrissette Drive, 113.13 to evaluate malignant brain tumors. published a Notice of Proposed We consider a brain tumor to be malignant Springfield, Virginia 22152, Telephone: Rulemaking entitled ‘‘Schedules of if it is classified as grade II or higher under (202) 307–7183. Controlled Substances: Placement of the World Health Organization (WHO) SUPPLEMENTARY INFORMATION: Fospropofol into Schedule IV’’ on July classification of tumors of the central nervous Background 23, 2009 (74 FR 36424), which proposed system (WHO Classification of Tumours of placement of fospropofol into schedule the Central Nervous System, 2007). We On December 12, 2008, the Food and IV of the CSA. The proposed rule evaluate any complications of malignant Drug Administration (FDA) approved brain tumors, such as resultant neurological provided an opportunity for all fospropofol for marketing under the interested persons to submit their or psychological impairments, under the ® criteria for the affected body system. We trade name Lusedra in the United written comments on or before August evaluate benign brain tumors under 111.05. States as a drug product indicated for 24, 2009. monitored anesthesia care (MAC) * * * * * Comments Received 113.09 Thyroid gland. sedation in adult patients undergoing B. * * * diagnostic or therapeutic procedures. The DEA received two comments in OR Fospropofol, 2,6- response to the Notice of Proposed C. Medullary carcinoma with metastases diisopropopylphenoxymethyl Rulemaking. One comment received beyond the regional lymph nodes. phosphate disodium, is a water soluble, from a concerned citizen did not relate * * * * * phosphono-O-methyl prodrug of to fospropofol, the substance that is 113.13 Brain tumors. (See 113.00K4.) propofol. It is metabolized in the body being controlled. Thus DEA did not Highly malignant tumors, such as to propofol, the active metabolite. consider this comment. VerDate Nov<24>2008 13:16 Oct 05, 2009 Jkt 220001 PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 E:\FR\FM\06OCR1.SGM 06OCR1 CPrice-Sewell on DSKGBLS3C1PROD with RULES Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Rules and Regulations 51235 Another comment received from a and must be manufactured, distributed, reviewed this final rule and by professional organization of and stored in accordance with approving it certifies that it will not anesthesiologists is in agreement with §§ 1301.71, 1301.72(b), (c), and (d), have a significant economic impact on the findings of scientific and medical 1301.73, 1301.74, 1301.75(b) and (c), a substantial number of small entities. evaluation that formed the basis for the 1301.76, and 1301.77 of Title 21 of the Fospropofol products will be used for present rule controlling fospropofol as a Code of Federal Regulations on or after monitored anesthesia care (MAC) schedule IV substance and it fully November 5, 2009. sedation in adult patients undergoing supported this control action. Labeling and Packaging. All labels diagnostic or therapeutic procedures. and labeling for commercial containers Handlers of fospropofol also handle Scheduling of Fospropofol of fospropofol must comply with other controlled substances used for Based on the recommendation of the requirements of §§ 1302.03–1302.07 of sedation which are already subject to Acting Assistant Secretary for Health, Title 21 of the Code of Federal the regulatory requirements of the CSA. received in accordance with section Regulations on or after November 5, Executive Order 12988 201(b) of the Act (21 U.S.C. 811(b)), and 2009. the independent review of the available Inventory. Every registrant required to This regulation meets the applicable data by DEA, the Deputy Administrator keep records and who possesses any standards set forth in Sections 3(a) and of DEA, pursuant to sections 201(a) and quantity of fospropofol must keep an 3(b)(2) of Executive Order 12988 Civil 201(b) of the Act (21 U.S.C. 811(a) and inventory of all stocks of fospropofol on Justice Reform. 811(b)), finds that: hand pursuant to §§ 1304.03, 1304.04 Executive Order 13132 (1) Fospropofol has a low potential for and 1304.11 of Title 21 of the Code of This rulemaking does not preempt or abuse relative to the drugs or substances Federal Regulations on or after modify any provision of state law; nor in schedule III. Although there is no November 5, 2009. Every registrant who does it impose enforcement direct comparison to a schedule III desires registration in schedule IV for responsibilities on any state; nor does it substance, this finding is based on the fospropofol must conduct an inventory diminish the power of any state to demonstration of the abuse potential of