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[Federal Register: March 30, 2010 (Volume 75, Number 60)]
[Proposed Rules]               
[Page 15642-15645]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30mr10-25]                         

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-335P]
RIN 1117-AB28

 
Schedules of Controlled Substances: Exempted Prescription 
Product; River Edge Pharmaceutical, Servira

AGENCY: Drug Enforcement Administration (DEA), Department of Justice.

ACTION: Notice of proposed rulemaking.

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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[supreg]. 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 
dea.diversion.policy@usdoj.gov. 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

[[Page 15643]]

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 (202) 307-7183.

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

[[Page 15644]]

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[supreg] (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[supreg] 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 Sec. Sec.  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 
Sec.  1308.32 by adding the following:

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                                                                                        Controlled     (mg or mg/
            Company                 Trade name        NDC code          Form            substance         ml)
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River's Edge Pharmaceutical...  Servira...........    68032-256  TB...............  Phenobarbital....       48.6
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[[Page 15645]]

    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.
[FR Doc. 2010-6035 Filed 3-29-10; 8:45 am]
BILLING CODE 4410-09-P
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