2010-6035. Schedules of Controlled Substances: Exempted Prescription Product; River Edge Pharmaceutical, Servira

AGENCY:

Drug Enforcement Administration (DEA), Department of Justice.

ACTION:

Notice of proposed rulemaking.

SUMMARY:

This Notice of Proposed Rulemaking proposes the amendment of the list of Exempted Prescription Products cited in the Code of Federal Regulations. This action is in response to DEA's review of new applications for exemption. DEA has received one new application for exemption for River Edge Pharmaceutical's Servira®. Having reviewed this application and relevant information, DEA finds that this preparation has no significant potential for abuse. Therefore, DEA hereby proposes that this product be added to the list of Exempted Prescription Products and exempted from the application of certain provisions of the Controlled Substances Act (CSA).

DATES:

Written comments must be postmarked and electronic comments must be submitted on or before April 29, 2010. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after Midnight Eastern Time on the last day of the comment period.

ADDRESSES:

To ensure proper handling of comments, please reference “Docket No. DEA-335” on all written and electronic correspondence. Written comments sent via regular or express mail should be sent to the Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODL, 8701 Morrissette Drive, Springfield, VA 22152. Comments may be sent to DEA by sending an electronic message to [e-mail]. Comments may also be sent electronically through http://www.regulations.gov using the electronic comment form provided on that site. An electronic copy of this document is also available at the http://www.regulations.gov Web site. DEA will accept attachments to electronic comments in Microsoft word, WordPerfect, Adobe PDF, or Excel file formats only. DEA will not accept any file formats other than those specifically listed here.

Please note that DEA is requesting that electronic comments be submitted before midnight Eastern time on the day the comment period closes because http://www.regulations.gov terminates the public's ability to submit comments at midnight Eastern time on the day the comment period closes. Commenters in time zones other than Eastern time may want to consider this so that their electronic comments are received. All comments sent via regular or express mail will be considered timely if postmarked on the day the comment period closes.

FOR FURTHER INFORMATION CONTACT:

Christine A. Sannerud, Ph.D., Chief, Drug and Chemical Evaluation Section, Office of Diversion Control, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152, Telephone [phone].

SUPPLEMENTARY INFORMATION:

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. 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 on http://www.regulations.gov.

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. Please note that the Freedom of Information Act applies to all comments received. If you wish to inspect the agency's public docket file in person by appointment, please see the FOR FURTHER INFORMATION CONTACT paragraph.

Background

The Controlled Substances Act as amended by the Dangerous Drug Diversion Control Act of 1984 authorizes the Attorney General in accordance with 21 U.S.C. 811(g)(3)(A) to exempt from specific provisions of the Act, a preparation or mixture if that preparation or mixture: (1) Contains a nonnarcotic controlled substance; (2) is approved for prescription use; and (3) contains one or more active ingredients that are not listed in any schedule and whose presence vitiates the potential for abuse of the nonnarcotic controlled substance. Such exemptions apply only to a specific prescription product and are only granted following suitable application to the Drug Enforcement Administration per 21 CFR 1308.31.

Exemption of Nonnarcotic Prescription Products

21 CFR 1308.31 provides an application procedure whereby any person may apply for exemption for nonnarcotic prescription products which meet certain criteria. 21 CFR 1308.31(a) further states that any person seeking to have any compound, mixture, or preparation containing any nonnarcotic controlled substance listed in 21 CFR 1308.12(e), or in 21 CFR 1308.13(b) or (c), or in 21 CFR 1308.14, or in 21 CFR 1308.15, exempted from application of all or any part of the CSA pursuant to 21 U.S.C. 811(g)(3)(A) may apply to the Administrator of DEA for such exemption.

21 CFR 1308.31(b) specifies that an application for an exemption shall contain the following information:

(1) The complete quantitative composition of the dosage form.

(2) Description of the unit dosage form together with complete labeling.

(3) A summary of the pharmacology of the product including animal investigations and clinical evaluations and studies, with emphasis on the psychic and/or physiological dependence liability (this must be done for each of the active ingredients separately and for the combination product).

(4) Details of synergisms and antagonisms among ingredients.

(5) Deterrent effects of the noncontrolled ingredients.

(6) Complete copies of all literature in support of claims.

(7) Reported instances of abuse.

(8) Reported and anticipated adverse effects.

(9) Number of dosage units produced for the past 2 years.

Within a reasonable period of time after the receipt of an application for an exemption under this section, 21 CFR 1308.31(c) states that the Administrator shall notify the applicant of the acceptance or non-acceptance of the application, and if not accepted, the reason therefor. The regulation states that the Administrator need not accept an application for filing if any of the requirements prescribed in 21 CFR 1308.31(b) is lacking or is not set forth so as to be readily understood. The regulation states that if accepted for filing, the Administrator shall publish in the Federal Register a general notice of proposed rulemaking in granting or denying the application. Such notice shall include a reference to the legal authority under which the rule is proposed, a statement of the proposed rule granting or denying an exemption, and, in the discretion of the Administrator, a summary of the subjects and issues involved.

The regulation further specifies that the Administrator shall permit any interested person to file written comments on or objections to the proposal and shall designate in the notice of proposed rulemaking the time during which such filings may be made. After consideration of the application and any comments on or objections to the proposed rulemaking, the Administrator shall issue and publish in the Federal Register a final order on the application, which shall set forth the findings of fact and conclusions of law upon which the order is based. This order shall specify the date on which it shall take effect, which shall not be less than 30 days from the date of publication in the Federal Register unless the Administrator finds that conditions of public health or safety necessitate an earlier effective date, in which event the Administrator shall specify in the order his findings as to such conditions.

21 CFR 1308.31(d) further states that the Administrator may revoke any exemption granted pursuant to 21 U.S.C. 811(g)(3)(A) by following the procedures set forth in 21 CFR 1308.31(c).

Redelegation of Authority

The Administrator has redelegated this authority to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, pursuant to 28 CFR 0.104, Appendix to Subpart R. The current Table of Exempted Prescription Products lists those products that have been granted exempt status prior to this update. That table can be viewed online at: http://www.deadiversion.usdoj.gov/​schedules/​exempt/​exempt_​list.htm.

Product Exemptions Subject to This Proposed Rulemaking

DEA received one application for exemption pursuant to the provisions of 21 CFR 1308.32 for:

River Edge Pharmaceutical's Servira® (NDC Code 68032-256) tablets containing 48.6 mg phenobarbital in combination with hyoscyamine sulfate, atropine sulfate and scopolamine hydrobromide.

The Deputy Assistant Administrator, Office of Diversion Control, having reviewed this application and relevant information, finds that this preparation contains a nonnarcotic controlled substance listed in 21 CFR 1308.14, also contains an active ingredient not listed in any controlled substance schedule, and has no significant potential for abuse.

The product Servira® contains the drug phenobarbital. Phenobarbital is a schedule IV controlled substance listed in 21 CFR 1308.14. The product also contains the anticholinergic ingredients hyoscyamine sulfate, atropine sulfate and scopolamine hydrobromide. These ingredients are not controlled substances. In the quantities included in the product, these ingredients have deterrent effects upon the product's potential for abuse.

Therefore, the Deputy Assistant Administrator hereby proposes that the following product is to be exempted from the application of sections 302 through 305, 307 through 309, and 1002 through 1004 of the Act (21 U.S.C. 822-825, 827-829, and 952-954) and §§ 1301.13, 1301.22, and 1301.71 through 1301.77 of this chapter. If this rule is finalized as proposed, the table that is available online will be updated to include the exempted prescription product included in this rulemaking.

Any interested person may file written comments or objections to this proposal. After consideration of the application and any comments or objections to the proposed rulemaking, the Deputy Assistant Administrator shall issue and publish in the Federal Register the final order of the application. The Deputy Assistant Administrator may revoke any exemption granted pursuant to 21 U.S.C. 811(g)(3)(A) by following the procedures set forth in 21 CFR 1308.31(c).

Regulatory Certifications

Regulatory Flexibility Act

The Deputy Assistant Administrator hereby certifies that this rulemaking has been drafted in accordance with the Regulatory Flexibility Act (5 U.S.C. 601-612), and by approving it certifies that this regulation will not have a significant economic impact upon a substantial number of small entities. This regulation will not have a significant impact upon firms who distribute these products. In fact, the approval of Exempted Prescription status for these products reduces the regulatory requirements for distribution of these materials.

Executive Order 12866

The Deputy Assistant Administrator further certifies that this rulemaking has been drafted in accordance with the principles of Executive Order 12866 Section 1(b). It has been determined that this is not a significant regulatory action. Therefore, this action has not been reviewed by the Office of Management and Budget.

Executive Order 12988

The Deputy Assistant Administrator further certifies that this regulation meets the applicable standards set forth in Sections 3(a) and 3(b)(2) of Executive Order 12988.

Executive Order 13132

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 the 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.

Under the authority vested in the Attorney General by section 202(d) of the Act (21 U.S.C. 811(g)(3)(B)) and delegated to the Administrator of the Drug Enforcement Administration by regulations of the Department of Justice (28 CFR Part 0.100), and redelegated to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, the Deputy Assistant Administrator hereby proposes to amend the Table of Exempted Prescription Products cited in § 1308.32 by adding the following:

Company	Trade name	NDC code	Form	Controlled substance	(mg or mg/ml)
River's Edge Pharmaceutical	Servira	68032-256	TB	Phenobarbital	48.6

Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted.

Dated: March 12, 2010.

Joseph T. Rannazzisi,

Deputy Assistant Administrator, Office of Diversion Control.