[Federal Register Volume 75, Number 60 (Tuesday, March 30, 2010)]
[Proposed Rules]
[Pages 15642-15645]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-6035]
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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
[email protected]. 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
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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
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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