Rules - 1998
[Federal Register Volume 63, Number 28 (Wednesday, February 11, 1998)]
[Rules and Regulations]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 98-3439]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[DEA No. 173F]
Schedules of Controlled Substances: Placement of Sibutramine Into Schedule IV
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
SUMMARY: With the issuance of this final rule, the Acting Deputy Administrator of the Drug Enforcement Administration (DEA) places the substance,
sibutramine, including its salts and optical isomers, into Schedule IV of the Controlled Substances Act (CSA). As a result of this rule, the regulatory controls and criminal sanctions of Schedule IV will be applicable to the manufacture, distribution, importation and exportation of sibutramine and products containing sibutramine.
EFFECTIVE DATE: February 11, 1998.
FOR FURTHER INFORMATION CONTACT: Frank Sapienza, Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration, Washington, DC 20537, Telephone: (202) 307-7183.
SUPPLEMENTARY INFORMATION: Sibutramine is an amphetamine analogue pharmacologically similar to other anorectic agents that produce central nervous system stimulation and amphetamine-like effects in humans and animals. Sibutramine hydrochloride will be marketed under the trade name of Meridia as an oral anorectic for the long-term management of obesity.
The Acting Deputy Administrator of the DEA received a letter dated November 12, 1997, from the Acting Assistant Secretary of Health, on behalf of the Secretary of the Department of Health and Human Services (DHHS), recommending that the substance, sibutramine, and its salts and isomers, be placed into Schedule IV of the CSA (21 U.S.C. 801 et seq.). Encloded with the letter from the Assistant Secretary was a document prepared by the Food and Drug Administration (FDA) entitled "Basis for the Recommendation for Control of Sibutramine and its Salts in Schedule IV of the Controlled Substances Act (CSA)." The document contained a review of the factors which the CSA requires the Secretary to consider [21 U.S.C. 811(b)] and the summarized recommendations regarding the placement of sibutramine into Schedule IV of the CSA. The Acting Deputy Administrator of the DEA, in a December 8, 1997, Federal Register notice (62 FR 64526), proposed placement of sibutramine into Schedule IV of the CSA. The notice provided an opportunity for all interested persons to submit their comments, objections, or requests for hearing in writing to be received by the DEA on or before January 7, 1998. The DEA received no comments, objections or requests for hearing.
Based on the scientific and medical evaluation and the recommendation of the Assistant Secretary for Health, the FDA New Drug Application (NDA) approval on November 22, 1997, and a DEA review, the Acting Deputy Administrator of the DEA, pursuant to sections 201(a) and 201(b) of the Act (21 U.S.C. 811(a) and 811(b)), finds that:
(1) Sibutramine has a low potential for abuse relative to the drugs or other substances in Schedule III.
(2) Sibutramine has a currently accepted medical use in treatment in the United States.
(3) Abuse of sibutramine may lead to limited physical and psychological dependence relative to drugs or other substances in Schedule III.
Based on these findings, the Acting Deputy Administrator of the DEA concludes that sibutramine, including its salts and isomers, warrants control in Schedule IV of the CSA. In order to make sibutramine pharmaceutical products available for medical use as soon as possible, the Schedule IV controls of sibutramine will be effective February 11, 1998. In the event that the regulations impose special hardships on the registrants, the DEA will entertain any justified request for an extension of time to comply with the Schedule IV regulations regarding sibutramine. The applicable regulations are as follows:
1. Registration. Any person who manufactures, distributes, dispenses, imports or exports sibutramine or who engages in research or conducts instructional activities with sibutramine, or who proposes to engage in such activities, must be registered to conduct such activities in accordance with Part 1301 of Title 21 of the Code of Federal Regulations.
2. Security. Sibutramine must be manufactured, distributed and stored in accordance with Secs. 1301.71, 1301.72 (b), (c), and (d), 1301.73, 1301.74, 1301.75 (b) and (c) and 1301.76 of Title 21 of the Code of Federal Regulations.
3. Labeling and Packaging. All labels on commercial containers of, and all labeling of, sibutramine which is distributed shall comply with the requirements of Secs. 1302.03-1302.07 of Title 21 of the Code of Federal Regulations.
4. Inventory. Registrants possessing sibutramine are required to take inventories pursuant to Secs. 1304.03, 1304.04 and 1304.11 of Title 21 of the Code of Federal Regulations.
5. Records. All registrants must keep records pursuant to Secs. 1304.03, 1304.04 and 1304.21-1304.23 of Title 21 of the Code of Federal Regulations.
6. Prescriptions. All prescriptions for sibutramine are to be issued pursuant to Secs. 1306.03-1306.06 and 1306.21-1306.26 of Title 21 of the Code of Federal Regulation.
7. Importation and Exportation. All importation and exportation of sibutramine shall be in compliance with Part 1312 of Title 21 of the Code of Federal Regulations.
8. Criminal Liability. Any activity with sibutramine not authorized by, or in violation of, the CSA or the Controlled Substances Import and Export Act shall be unlawful.
In accordance with the provisions of the CSA [21 U.S.C. 811(a)], this action is a formal rulemaking on the record after opportunity for a hearing. Such proceedings are conducted pursuant to the provisions of 5 U.S.C. 556 and 557 and, as such, are exempt from review by the Office of Management and Budget pursuant to Executive Order (E.O.) 12866, Section 3(d)(1).
The Acting Deputy Administrator, in accordance with the Regulatory Flexibility Act [5 U.S.C. 605(b)], has reviewed this final rule and, by approving it, certifies that it will not have a significant economic impact on a substantial number of small-business entities. Sibutramine is a new drug in the United States; recent approval of the product and its labeling by the FDA will allow it to be marketed once it is placed into Schedule IV of the CSA. This final rule, will allow these entities to have access to a new pharmaceutical product.
This rule will not result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under provisions of the Unfunded Mandates Reform Act of 1995.
This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of the United States-based companies to compete with foreign-based companies in domestic and export markets.
This rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with E.O. 12612, it is determined that this rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.
List of Subjects in 21 CFR Part 1308
Administraitve practice and procedure, Drug traffic control, Narcotics, Prescription drugs.
Under the authority vested in the Attorney general by section 201(a) of the CSA [21 U.S.C. 811(a)], and delegated to the Administrator of the DEA by the Department of Justice regulations (28 CFR 0.100) and redelegated to the Deputy Administrator pursuant to 28 CFR 0.104, the Acting Deputy Administrator hereby amends 21 CFR part 1308 as follows:
1. The authority citation for 21 CFR part 1308 continues to read as follows:
Authority: 21 U.S.C. 811, 812, 871(b) unless otherwise noted.
2. Section 1308.14 is amended by redesignating the existing paragraph (e)(10) as (e)(11) and adding a new paragraph (e)(10) to read as follows:
Sec. 1308.14 Schedule IV.
* * * * *
(e) * * *
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Dated: February 5, 1998.
Peter F. Gruden,
Acting Deputy Administrator.
[FR Doc. 98-3439 Filed 2-10-98; 8:45 am]
BILLING CODE 4410-09-M
NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Printing Office (GPO).