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Drug Enforcement Administration, Department of Justice.
Notice of proposed rulemaking.
This proposed rule is issued by the Deputy Administrator of the Drug Enforcement Administration (DEA) to place the substance indiplon (N-methyl-N-[3-[3-(2-thienylcarbonyl)-pyrazolo[1,5-a]pyrimidin-7-Start Printed Page 5779yl]phenyl]acetamide), including its salts, and all products containing indiplon into schedule IV of the Controlled Substances Act (CSA). This proposed action is based on a recommendation from the Assistant Secretary for Health of the Department of Health and Human Services (DHHS) and an evaluation of the relevant data by DEA. This scheduling of indiplon in schedule IV will not be finalized until a New Drug Application (NDA) for an indiplon product is approved by the Food and Drug Administration (FDA). If finalized, this action will impose the regulatory controls and criminal sanctions applicable to schedule IV non-narcotics on those who handle indiplon and products containing indiplon.
Written comments must be postmarked, and electronic comments must be sent, on or before March 3, 2008.
To ensure proper handling of comments, please reference “Docket No. DEA-283” on all written and electronic correspondence. Written comments being sent via regular mail should be sent to the Deputy Administrator, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA Federal Register Representative/ODL. Written comments sent via express mail should be sent to the Deputy Administrator, Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODL, 8701 Morrissette Drive, Springfield, VA 22152. Comments may be directly sent to DEA electronically by sending an electronic message to firstname.lastname@example.org. Comments may also be sent electronically through http://www.regulations.gov using the electronic comment form provided on that site. However, persons wishing to request a hearing should note that such requests must be written and manually signed; requests for a hearing will not be accepted via electronic means. DEA will accept electronic comments containing MS Word, WordPerfect, Adobe PDF, or Excel file formats only. DEA will not accept any file format other than those specifically listed here.
Posting of Public Comments: Please note that all comments received are considered part of the public record and made available for public inspection online at http://www.regulations.gov and in the Drug Enforcement Administration's public docket. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter.
If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all the personal identifying information you do not want posted online or made available in the public docket in the first paragraph of your comment and identify what information you want redacted.
If you want to submit confidential business information as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be posted online or made available in the public docket.
Personal identifying information and confidential business information identified and located as set forth above will be redacted and the comment, in redacted form, will be posted online and placed in the Drug Enforcement Administration's public docket file. If you wish to inspect the agency's public docket file in person by appointment, please see the FOR FURTHER INFORMATION paragraph.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Christine A. Sannerud, PhD, Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration, Washington, DC 20537, (202) 307-7183.End Further Info End Preamble Start Supplemental Information
Note Regarding This Proposed Scheduling Action
In accordance with the provisions of the Controlled Substances Act (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 the Administrative Procedure Act (5 U.S.C. 556 and 557). Interested persons are invited to submit their comments, objections or requests for a hearing with regard to this proposal. Persons wishing to request a hearing should note that such requests must be written and manually signed; requests for a hearing will not be accepted via electronic means. Requests for a hearing should be made in accordance with 21 CFR 1308.44 and should state, with particularity, the issues concerning which the person desires to be heard. All correspondence regarding this matter should be submitted to the DEA using the address information provided above.
Indiplon acts as an agonist at benzodiazepine sites of the GABAA receptor-channel complex. It has comparable sedative/hypnotic action to that of the benzodiazepines, diazepam and triazolam, and non-benzodiazepines that bind to the GABAA complex, such as zolpidem, zaleplon and zopiclone, all of which are controlled as depressants in schedule IV of the CSA. Indiplon has a similar pharmacological profile as these substances in addition to a short plasma half-life and short duration of action. In a human abuse-liability study in individuals with known histories of sedative abuse, oral administration of indiplon (30 mg, 50 mg and 80 mg) produced dose-dependent increases in drug-liking and decreases in psychomotor and cognitive functioning comparable to those produced by the schedule IV benzodiazepine, triazolam. Indiplon is likely to be diverted and abused in the same manner as other schedule IV depressants.
The FDA has received two NDAs for indiplon products, Somposure® and Somposure® MR. These products are currently under review for the treatment of insomnia, as characterized by difficulty in sleep onset or sleep maintenance. Indiplon is a new chemical entity and has not been marketed in the United States or in other countries.
On January 23, 2006, the Assistant Secretary for Health of the DHHS sent the Administrator of the DEA a scientific and medical evaluation and a letter recommending that indiplon be placed into schedule IV of the CSA. Enclosed with the January 23, 2006, letter was a document prepared by the FDA entitled, “Basis for the Recommendation for Control of Indiplon 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)).
The factors considered by the Assistant Secretary of Health and DEA with respect to Indiplon were:
(1) Its actual or relative potential for abuse;
(2) Scientific evidence of its pharmacological effects;
(3) The state of current scientific knowledge regarding the drug;
(4) Its history and current pattern of abuse; Start Printed Page 5780
(5) The scope, duration, and significance of abuse;
(6) What, if any, risk there is to the public health;
(7) Its psychic or physiological dependence liability; and
(8) Whether the substance is an immediate precursor of a substance already controlled under this subchapter (21 U.S.C. 811(c)).
Based on the recommendation of the Assistant Secretary for Health, received in accordance with section 201(b) of the Act (21 U.S.C. 811(b)), and the independent review of the available data by the DEA, the Deputy Administrator of the DEA, pursuant to section 201(a) and 201(b) of the Act (21 U.S.C. 811(a) and 811(b)), finds that:
(1) Based on information now available, indiplon has a low potential for abuse relative to the drugs or other substances in schedule III;
(2) Once approved for marketing, indiplon will have a currently accepted medical use in treatment in the United States; and
(3) Abuse of indiplon may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule III.
Based on these findings, the Deputy Administrator of the DEA concludes that indiplon, including its salts, and all products containing indiplon, warrant control in schedule IV of the CSA, if and when a NDA for indiplon is approved.
Interested persons are invited to submit their comments, objections or requests for a hearing with regard to this proposal. Requests for a hearing should state, with particularity, the issues concerning which the person desires to be heard. All correspondence regarding this matter should be submitted to the Drug Enforcement Administration using the address information provided above. Persons wishing to request a hearing should note that such requests must be written and manually signed; requests for a hearing will not be accepted via electronic means. In the event that comments, objections, or requests for a hearing raise one or more issues which the Deputy Administrator finds warrant a hearing, the Deputy Administrator shall order a public hearing by notice in the Federal Register, summarizing the issues to be heard and setting the time for the hearing.
Requirements for Handling Indiplon
If this rule is finalized as proposed, indiplon and all products containing indiplon would be subject to the Controlled Substances Act and the Controlled Substances Import and Export Act regulatory controls and administrative, civil and criminal sanctions applicable to the manufacture, distribution, dispensing, importing and exporting of a schedule IV controlled substance, including the following:
Registration. Any person who manufactures, distributes, dispenses, imports, exports, engages in research or conducts instructional activities with indiplon, or who desires to manufacture, distribute, dispense, import, export, engage in instructional activities or conduct research with indiplon, would need to register with the DEA to conduct such activities in accordance with part 1301 of Title 21 of the Code of Federal Regulations.
Security. Indiplon would be subject to schedule III-V security requirements and must be manufactured, distributed and stored in accordance with 21 CFR 1301.71, 1301.72(b), (c), and (d), 1301.73, 1301.74, 1301.75(b) and (c), 1301.76, and 1301.77.
Labeling and Packaging. All labels and labeling for commercial containers of indiplon which are distributed on or after finalization of this rule would need to comply with requirements of 21 CFR 1302.03-1302.07.
Inventory. Every registrant required to keep records and who possesses any quantity of indiplon would be required to keep an inventory of all stocks of indiplon on hand pursuant to 21 CFR 1304.03, 1304.04 and 1304.11. Every registrant who desires registration in schedule IV for indiplon would be required to conduct an inventory of all stocks of the substance on hand at the time of registration.
Records. All registrants would be required to keep records pursuant to 21 CFR 1304.03, 1304.04, 1304.05, 1304.21, 1304.22, and 1304.23.
Prescriptions. All prescriptions for indiplon or prescriptions for products containing indiplon would be required to be issued pursuant to 21 CFR 1306.03-1306.06, 1306.21-1306.27.
Importation and Exportation. All importation and exportation of indiplon would need to be in compliance with 21 CFR Part 1312.
Criminal Liability. Any activity with indiplon not authorized by, or in violation of, the Controlled Substances Act or the Controlled Substances Import and Export Act occurring on or after finalization of this proposed rule would be unlawful.
Executive Order 12866
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 12866, section 3(d)(1).
Regulatory Flexibility Act
The Deputy Administrator, in accordance with the Regulatory Flexibility Act (5 U.S.C. 601-612), 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. Indiplon products will be prescription drugs used for the treatment of insomnia. Handlers of indiplon often handle other controlled substances which are already subject to the regulatory requirements of the CSA.
This regulation meets the applicable standards set forth in section 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.
This rulemaking does not preempt or modify any provision of state law; nor does it impose enforcement responsibilities on any state; nor does it diminish the power of any state to enforce its own laws. Accordingly, this rulemaking does not have federalism implications warranting the application of Executive Order 13132.
Unfunded Mandates Reform Act of 1995
This rule will not result in the expenditure by state, local and tribal governments, in the aggregate, or by the private sector, of $120,000,000 or more (adjusted for inflation) in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under provisions of the Unfunded Mandates Reform Act of 1995.
Congressional Review Act
This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act). 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 United States-based companies to compete with foreign based companies in domestic and export markets.Start List of Subjects Start Printed Page 5781
List of Subjects in 21 CFR Part 1308End List of Subjects
Under the authority vested in the Attorney General by § 201(a) of the CSA (21 U.S.C. 811(a)), and delegated to the Administrator of DEA by Department of Justice regulations (28 CFR 0.100), and redelegated to the Deputy Administrator pursuant to 28 CFR 0.104, the Deputy Administrator hereby proposes that 21 CFR part 1308 be amended as follows:Start Part
PART 1308—SCHEDULES OF CONTROLLED SUBSTANCES
1. The authority citation for 21 CFR part 1308 continues to read as follows:
2. Section 1308.14 is amended by redesignating paragraphs (c)(25) through (c)(51) as (c)(26) through (c)(52) and adding a new paragraph (c)(25) to read as follows:
(c) * * *
(25) indiplon (N-methyl-N-[3-[3-(2-thienylcarbonyl)-pyrazolo[1,5-a]pyrimidin-7-yl]phenyl]-acetamide)—2726
Dated: January 22, 2008.
Michele M. Leonhart,
[FR Doc. E8-1692 Filed 1-30-08; 8:45 am]
BILLING CODE 4410-09-P