Vol. 76 Monday, No. 238 December 12, 2011 Part II Department of Justice Drug Enforcement Administration 21 CFR Part 1308 Schedules of Controlled Substances: Placement of Carisoprodol Into Schedule IV; Final Rule VerDate Mar<15>2010 15:56 Dec 09, 2011 Jkt 226001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\12DER2.SGM 12DER2 jlentini on DSK4TPTVN1PROD with RULES2 77330 Federal Register / Vol. 76, No. 238 / Monday, December 12, 2011 / Rules and Regulations DEPARTMENT OF JUSTICE (1) [The drug’s] actual or relative that the then-available data did not potential for abuse. support controlling carisoprodol. Id. Drug Enforcement Administration (2) Scientific evidence of its Thereafter, at the direction of the pharmacological effect, if known. National Institute on Drug Abuse 21 CFR Part 1308 (3) The state of current scientific (NIDA) and the College of Problems of knowledge regarding the drug or other Drug Dependence (CPDD), additional [Docket No. DEA–333] substance. pharmacological studies of (4) Its history and current pattern of carisoprodol’s abuse liability were Schedules of Controlled Substances: abuse. conducted. In the meantime, DEA Placement of Carisoprodol Into (5) The scope, duration, and gathered additional new data on actual Schedule IV significance of abuse. abuse and law enforcement encounters (6) What, if any, risk there is to the involving the drug, as well as other AGENCY: Drug Enforcement information, which it sent to HHS on Administration, Department of Justice. public health. (7) Its psychic or physiological November 14, 2005. FDA also acquired ACTION: Final rule. dependence liability. new data from the Drug Abuse Warning Network (DAWN), the National Survey SUMMARY: With the issuance of this final (8) Whether the substance is an rule, the Administrator of the Drug immediate precursor of a substance on Drug Use and Health (NSDUH), Enforcement Administration (DEA) already controlled under this Florida Medical Examiners Commission places the substance carisoprodol, subchapter. reports, FDA’s Adverse Event Reporting including its salts, isomers, and salts of 21 U.S.C. 811(c). System, as well as other information isomers, whenever the existence of such However, ‘‘before initiating from a variety of sources. On October 6, 2009, HHS concluded salts, isomers, and salts of isomers is proceedings * * * to control a drug its review of the evidence pertaining to possible, into Schedule IV of the * * * and after gathering the necessary the eight factors set forth in 21 U.S.C. Controlled Substances Act (CSA). This data,’’ the Attorney General is required 811 and recommended that carisoprodol action is pursuant to the CSA which to ‘‘request from the Secretary a be placed in schedule IV. GX 6, at 1. requires that such actions be made on scientific and medical evaluation, and Thereafter, on November 17, 2009, DEA the record after opportunity for a his recommendations, as to whether issued a Notice of Proposed hearing. The decision of the such drug * * * should be controlled.’’ Rulemaking, which proposed placing Administrator is reprinted in its entirety Id. 811(b). The statute further provides carisoprodol in schedule IV. ALJ Ex., at below. that ‘‘[i]n making such evaluation and 1 (74 FR 59108). Therein, DEA invited recommendations, the Secretary shall DATES: Effective Date: January 11, 2012. all persons to submit written comments consider the Factors listed in paragraphs FOR FURTHER INFORMATION CONTACT: or objections to the proposed rule; DEA (2), (3), (6), (7), and (8) of subsection (c) Rhea D. Moore, Drug Enforcement also notified ‘‘interested persons’’ of * * * and any scientific or medical Administration, 8701 Morrissette Drive, their right to request a hearing. Id. at 2 considerations involved in paragraphs Springfield, Virginia 22152; Telephone (citing 5 U.S.C. 556 and 557). (202) 307–5268. (1), (4), and (5) of such subsection. The DEA received seventeen comments on recommendations of the Secretary shall SUPPLEMENTARY INFORMATION: the proposed rule; sixteen of the include recommendations with respect commenters (which included law ALJ Docket No. 10–46 to the appropriate schedule, if any, enforcement officials, medical under which such drug * * * should be Background professionals and state regulators) listed.’’ Id. supported the proposed rulemaking.1 This is a proceeding under 21 U.S.C. Finally, ‘‘[t]he recommendations of One entity, Meda Pharmaceuticals, Inc. 811(a) for the issuance of a rule placing the Secretary to the Attorney General (Meda), which manufactures the carisoprodol in schedule IV of the shall be binding as to such scientific branded drug Soma, objected to the Controlled Substances Act (CSA). Under and medical matters, and if the proposed rule on the ground that the this provision, ‘‘the Attorney General Secretary recommends that a drug ‘‘the administrative record does not may, by rule,’’ add a ‘‘drug or other * * * not be controlled, the Attorney include substantial and reliable substance’’ to one of the five schedules General shall not control the drug evidence of potential for abuse of controlled substances, ‘‘if he * * * * * *. If the Attorney General sufficient to warrant scheduling finds that such drug or other substance determines that these facts and all other carisoprodol and because the proposal has a potential for abuse, and * * * relevant data constitute substantial gives inadequate weight to the negative makes with respect to such drug or evidence of potential for abuse such as impact on patient care of scheduling other substance the findings prescribed to warrant control * * * he shall carisoprodol.’’ ALJ Ex. 2, at 3. Meda also by [21 U.S.C. 812(b)] for the schedule in initiate proceedings for control * * * requested a hearing. Id. at 1. On March which such drug is to be placed.’’ 21 under subsection (a) of this section.’’ Id. 21, 2010, I granted Meda’s request and U.S.C. 811(a). However, a rule made assigned the matter to the Agency’s under this provision ‘‘shall be made on Procedural History Office of Administrative Law Judges the record after opportunity for a Pursuant to section 811(b), in March (ALJ). ALJ Ex. 3, at 2. 1996, the Drug Enforcement hearing pursuant to the rulemaking Following pre-hearing procedures, an Administration (DEA) requested from procedures prescribed by subchapter II ALJ conducted a hearing on July 6, 8, of chapter 5 of Title 5.’’ Id. the Department of Health and Human ‘‘[W]ith respect to each drug * * * Services (HHS) a scientific and medical 1 None of the commenters raised any issue as to proposed to be controlled,’’ the CSA evaluation of carisoprodol, and a the various Regulatory Certifications contained in requires that the Attorney General recommendation as to whether it should the Notice of Proposed Rulemaking. See 74 FR at consider eight factors in making the be controlled. ALJ Ex 1, at 3. In 59111. One commenter, which represents wholesale distributors, requested that if the proposed rule is findings required under both February 1997, however, the U.S. Food finalized, its effective date be set at 120 days from subsections 811(a) and 812(b). These and Drug Administration’s (FDA) Drug the date of publication to provide adequate time to are: Abuse Advisory Committee concluded comply with various regulations. VerDate Mar<15>2010 15:56 Dec 09, 2011 Jkt 226001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\FR\FM\12DER2.SGM 12DER2 jlentini on DSK4TPTVN1PROD with RULES2 Federal Register / Vol. 76, No. 238 / Monday, December 12, 2011 / Rules and Regulations 77331 and 9, as well as on August 3–6, 2010. center, that he could not recall a single The ALJ then discussed three At the hearing, both the Government case of a person being treated at his different human studies. With respect to and Meda elicited the testimony of center for dependence on carisoprodol the Fraser study,2 the ALJ noted that witnesses and introduced various and his opinion that ‘‘the data and Meda’s Expert interpreted the results as documents into evidence. Thereafter, information presented by the FDA and showing that ‘‘ingestions ‘did not both the Government and Meda filed DEA do not establish that carisoprodol induce a characteristic barbiturate briefs containing their proposed has a potential for abuse similar’’ to intoxication pattern * * *, nor did the findings of fact and conclusions of law. schedule IV controlled substances. Id. abrupt withdrawal of carisoprodol reveal any signs of barbiturate-like The ALJ’s Recommended Decision However, the ALJ found ‘‘more compelling’’ data compiled by Meda abstinence’ behavior.’’ Id. at 85. On December 8, 2010, the ALJ issued and the predecessor holders of the New However, the ALJ then noted that ‘‘the her recommended decision. Therein, Drug Application for carisoprodol FDA and the DEA found that the prior to discussing the eight ‘‘factors which had been submitted to the FDA’s subjective and objective effects were determinative of control,’’ 21 U.S.C. Adverse Events Reporting System similar to those of barbiturates or 811(c), the ALJ discussed the weight to (AERS). Id. at 82. This data, which alcohol and different from those of be given the FDA’s findings as to includes reports from consumers and opiates’’ and that the drug ‘‘has scientific and medical matters. ALJ at 6; healthcare practitioners, showed that sedative-like effects.’’ Id. Here again, the see also 21 U.S.C. 811(b). As explained between January 1979 and May 1, 2010, ALJ found FDA’s findings binding on more fully below, the ALJ adopted the there had been ‘‘731 spontaneous the proceeding. Id. Government’s argument that the statute adverse event’’ reports of which eighty- Next, the ALJ discussed the studies ‘‘limits the scope of the administrative three used such terms as abuse, Meda had conducted to obtain FDA hearing to those issues outside of the dependency or withdrawal. Id. at 82–83. approval to market a smaller-strength medical and scientific fact-findings of The ALJ further noted that in 2009, dose.