Schedules of Controlled Substances: Exempted Prescription Product; River Edge Pharmaceutical, Servira, 15642-15645 [2010-6035]
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15642
Federal Register / Vol. 75, No. 60 / Tuesday, March 30, 2010 / Proposed Rules
Title: Revision of the Requirements
for Constituent Materials.
Description: The proposed rule would
permit the Director of CBER or the
Director of CDER, as appropriate, to
approve a manufacturer’s request for
exceptions or alternatives to the
regulation for constituent materials.
This proposed rule provides
manufacturers of biological products
with flexibility, as appropriate, to
employ advances in science and
technology as they become available,
without diminishing public health
protections. Manufacturers seeking
approval of an exception or alternative
must submit a request in writing. The
request must be clearly identified with
a brief statement describing the basis for
the request and supporting data. The
request may be submitted as part of the
original biologics license application, as
an amendment to the original, pending
application or as a prior approval
supplement to an approved application.
The information to be collected will
assist FDA in identifying and reviewing
requests for an exception or alternative
to the requirements for constituent
materials.
Description of Respondents:
Manufacturers of biological products.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
610.15
1 There
Annual Frequency
per Response
3
Total Annual
Responses
1
3
Total Hours
1
3
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on FDA experience, we
estimate that we will receive a total of
approximately 3 requests annually for
an exception or alternative under
§ 610.15. The hours per response are
based on FDA experience with similar
information collection requirements.
In compliance with the PRA (44
U.S.C. 3507(d)), the agency has
submitted the information collection
provisions of this proposed rule to OMB
for review. Interested persons are
requested to send comments regarding
information collection to OMB (see
DATES and ADDRESSES).
372, 374, 381; 42 U.S.C. 216, 262, 263, 263a,
264.
VI. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
WReier-Aviles on DSKGBLS3C1PROD with PROPOSALS
Hours per
Response
Dated: March 25, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
List of Subjects in 21 CFR Part 610
Biologics, Labeling, Reporting and
Recordkeeping requirements.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and the Public
Health Service Act, and under authority
delegated to the Commissioner of Food
and Drugs, it is proposed that 21 CFR
part 610 be amended as follows:
Schedules of Controlled Substances:
Exempted Prescription Product; River
Edge Pharmaceutical, Servira
PART 610—GENERAL BIOLOGICAL
PRODUCTS STANDARDS
1. The authority citation for 21 CFR
part 610 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 355, 360, 360c, 360d, 360h, 360i, 371,
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2. Amend § 610.15 by adding new
paragraph (d) to read as follows:
§ 610.15
Constituent materials.
*
*
*
*
*
(d) The Director of the Center for
Biologics Evaluation and Research or
the Director of the Center for Drug
Evaluation and Research may approve
an exception or alternative to any
requirement in this section. Requests for
such exceptions or alternatives must be
in writing.
[FR Doc. 2010–7073 Filed 3–29–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–335P]
RIN 1117–AB28
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
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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
dea.diversion.policy@usdoj.gov.
Comments may also be sent
electronically through https://
www.regulations.gov using the
electronic comment form provided on
that site. An electronic copy of this
document is also available at the
https://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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Federal Register / Vol. 75, No. 60 / Tuesday, March 30, 2010 / Proposed Rules
https://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 https://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 https://
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
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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.
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(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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Federal Register / Vol. 75, No. 60 / Tuesday, March 30, 2010 / Proposed Rules
update. That table can be viewed online
at: https://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 foreignbased 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:
Trade name
NDC code
Form
Controlled substance
River’s Edge Pharmaceutical .......
WReier-Aviles on DSKGBLS3C1PROD with PROPOSALS
Company
Servira ........................................
68032–256
TB ...........
Phenobarbital ..............................
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(mg or
mg/ml)
48.6
Federal Register / Vol. 75, No. 60 / Tuesday, March 30, 2010 / Proposed Rules
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
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R06–OAR–2010–0147; FRL–9130–4]
Approval and Promulgation of Air
Quality Implementation Plans; Texas;
Revisions to the Emission Credit
Banking and Trading Program
WReier-Aviles on DSKGBLS3C1PROD with PROPOSALS
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
SUMMARY: EPA is proposing to approve
severable portions of two revisions to
the Texas State Implementation Plan
(SIP) submitted by the State of Texas on
October 24, 2006, and August 16, 2007.
These revisions amend existing sections
and create a new section in Title 30 of
the Texas Administrative Code (TAC),
Chapter 101—General Air Quality
Rules, Subchapter H—Emissions
Banking and Trading, Division 1—
Emission Credit Banking and Trading,
referred to elsewhere in this notice as
the Emission Reduction Credit (ERC)
Program. The October 24, 2006,
submittal creates a new section for
international emission reduction
provisions and amends existing sections
to further clarify procedures for using
emission protocols and to update the
approved list of emission credit uses.
The August 16, 2007, submittal amends
two sections of the ERC program to
update cross-references to recently
recodified 30 TAC Chapter 117
provisions. EPA has determined that
these SIP revisions comply with the
Clean Air Act and EPA regulations, are
consistent with EPA policies, and will
improve air quality. This action is being
taken under section 110 and parts C and
D of the Federal Clean Air Act (the Act
or CAA).
DATES: Comments must be received on
or before April 29, 2010.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–R06–
OAR–2010–0147, by one of the
following methods:
(1) https://www.regulations.gov:
Follow the on-line instructions for
submitting comments.
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(2) E-mail: Mr. Jeff Robinson at
robinson.jeffrey@epa.gov. Please also cc
the person listed in the FOR FURTHER
INFORMATION CONTACT paragraph below.
(3) U.S. EPA Region 6 ‘‘Contact Us’’
Web site: https://epa.gov/region6/
r6coment.htm. Please click on ‘‘6PD’’
(Multimedia) and select ‘‘Air’’ before
submitting comments.
(4) Fax: Mr. Jeff Robinson, Chief, Air
Permits Section (6PD–R), at fax number
214–665–6762.
(5) Mail: Mr. Jeff Robinson, Chief, Air
Permits Section (6PD–R), Environmental
Protection Agency, 1445 Ross Avenue,
Suite 1200, Dallas, Texas 75202–2733.
(6) Hand or Courier Delivery: Mr. Jeff
Robinson, Chief, Air Permits Section
(6PD–R), Environmental Protection
Agency, 1445 Ross Avenue, Suite 1200,
Dallas, Texas 75202–2733. Such
deliveries are accepted only between the
hours of 8:30 a.m. and 4:30 p.m.
weekdays except for legal holidays.
Special arrangements should be made
for deliveries of boxed information.
Instructions: Direct your comments to
Docket ID No. EPA–R06–OAR–2010–
0147. EPA’s policy is that all comments
received will be included in the public
docket without change and may be
made available online at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
the disclosure of which is restricted by
statute. Do not submit information
through https://www.regulations.gov or
e-mail, if you believe that it is CBI or
otherwise protected from disclosure.
The https://www.regulations.gov Web
site is an ‘‘anonymous access’’ system,
which means that EPA will not know
your identity or contact information
unless you provide it in the body of
your comment. If you send an e-mail
comment directly to EPA without going
through https://www.regulations.gov,
your e-mail address will be
automatically captured and included as
part of the comment that is placed in the
public docket and made available on the
Internet. If you submit an electronic
comment, EPA recommends that you
include your name and other contact
information in the body of your
comment along with any disk or CD–
ROM submitted. If EPA cannot read
your comment due to technical
difficulties and cannot contact you for
clarification, EPA may not be able to
consider your comment. Electronic files
should avoid the use of special
characters and any form of encryption
and should be free of any defects or
viruses. For additional information
about EPA’s public docket, visit the EPA
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15645
Docket Center homepage at https://
www.epa.gov/epahome/dockets.htm.
Docket: All documents in the docket
are listed in the https://
www.regulations.gov index. Although
listed in the index, some information is
not publicly available, e.g., CBI or other
information the disclosure of which is
restricted by statute. Certain other
material, such as copyrighted material,
will be publicly available only in hard
copy. Publicly available docket
materials are available either
electronically in https://
www.regulations.gov or in hard copy at
the Air Permits Section (6PD–R),
Environmental Protection Agency, 1445
Ross Avenue, Suite 700, Dallas, Texas
75202–2733. The file will be made
available by appointment for public
inspection in the Region 6 FOIA Review
Room between the hours of 8:30 a.m.
and 4:30 p.m. weekdays except for legal
holidays. Contact the person listed in
the FOR FURTHER INFORMATION CONTACT
paragraph below to make an
appointment. If possible, please make
the appointment at least two working
days in advance of your visit. A 15 cent
per page fee will be charged for making
photocopies of documents. On the day
of the visit, please check in at the EPA
Region 6 reception area on the seventh
floor at 1445 Ross Avenue, Suite 700,
Dallas, Texas.
The State submittal related to this SIP
revision, and which is part of the EPA
docket, is also available for public
inspection at the State Air Agency listed
below during official business hours by
appointment:
Texas Commission on Environmental
Quality, Office of Air Quality, 12124
Park 35 Circle, Austin, Texas 78753.
FOR FURTHER INFORMATION CONTACT: If
you have questions concerning today’s
proposed rule, please contact Ms. Adina
Wiley (6PD–R), Air Permits Section,
Environmental Protection Agency,
Region 6, 1445 Ross Avenue (6PD–R),
Suite 1200, Dallas, TX 75202–2733. The
telephone number is (214) 665–2115.
Ms. Wiley can also be reached via
electronic mail at wiley.adina@epa.gov.
SUPPLEMENTARY INFORMATION:
Throughout this document wherever,
any reference to ‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is
used, we mean EPA.
Table of Contents
I. What Action Is EPA Taking?
II. What Did Texas Submit?
III. What Is EPA’s Evaluation of These SIP
Revisions?
IV. Final Action
V. Statutory and Executive Order Reviews
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]]>Agencies
[Federal Register Volume 75, Number 60 (Tuesday, March 30, 2010)]
[Proposed Rules]
[Pages 15642-15645]
From the Federal Register Online via the Government Printing 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.
-----------------------------------------------------------------------
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 https://www.regulations.gov using the electronic
comment form provided on that site. An electronic copy of this document
is also available at the https://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]]
https://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 https://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 https://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: https://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:
----------------------------------------------------------------------------------------------------------------
Controlled (mg or mg/
Company Trade name NDC code Form substance ml)
----------------------------------------------------------------------------------------------------------------
River's Edge Pharmaceutical... Servira........... 68032-256 TB............... Phenobarbital.... 48.6
----------------------------------------------------------------------------------------------------------------
[[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
