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[Federal Register: September 2, 2010 (Volume 75, Number 170)]
[Rules and Regulations]               
[Page 53867-53870]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02se10-13]                         

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1310

[Docket No. DEA-334F]
RIN 1117-AB29

 
Additions to Listing of Exempt Chemical Mixtures

AGENCY: Drug Enforcement Administration (DEA), Department of Justice.

ACTION: Direct final rule.

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SUMMARY: Under this Direct Final Rule, the Drug Enforcement 
Administration (DEA) is updating the Table of Exempt Chemical Mixtures. 
This action is in response to DEA's review of new applications for 
exemption. Having reviewed applications and relevant information, DEA 
finds that these 21 preparations meet the applicable exemption 
criteria. Therefore, these products are exempted from the application 
of certain provisions of the Controlled Substances Act (CSA).

DATES: This Direct Final Rule is effective November 1, 2010 without 
further action, unless adverse comment is received by DEA no later than 
October 4, 2010. If any comments or objections raise significant issues 
regarding any findings of fact or conclusions of law upon which the 
order is based, the Administrator may suspend the effectiveness of the 
order until she has reconsidered the application in light of the 
comments and objections filed.
    Written comments must be postmarked and electronic comments must be 
submitted on or before October 4, 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-334'' 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 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, PhD, 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: Any interested person may file comments or 
objections to this order, on or before November 1, 2010. If any such 
comments or objections raise significant issues regarding any findings 
of fact or conclusions of law upon which the order is based, the Deputy 
Administrator may suspend the effectiveness of the order until she has 
reconsidered the application in light of the comments and objections 
filed. Thereafter, the Deputy Administrator shall reinstate, terminate, 
or amend the original order as deemed appropriate.
    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

[[Page 53868]]

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 paragraph.

New Exempt Chemical Mixtures

    Pursuant to provisions of 21 CFR 1310.13 discussed further below, 
the manufacturers of 21 chemical mixtures listed below, in the form and 
quantity listed in the application submitted (indicated as the 
``date'') have applied for exemption pursuant to 21 CFR 1310.13. DEA 
has reviewed the applications received, as well as any additional 
information that may have been requested. It has been determined that 
(1) each of these chemical mixtures is formulated in such a way that 
they cannot be easily used in the illicit production of a controlled 
substance; and (2) the listed chemical(s) contained in these chemical 
mixtures cannot be readily recovered. Therefore, each of these 
manufacturers has received a DEA letter granting exempted status on the 
date shown in the attached table. This regulatory action conforms DEA 
regulations to the exemptions previously issued.

Background

    21 CFR 1310.13 provides that the Administrator of DEA may, by 
publication of a Final Rule in the Federal Register, exempt from the 
application of all or any part of the CSA a chemical mixture consisting 
of two or more chemical components, at least one of which is not a List 
I or List II chemical, if:
    (1) The mixture is formulated in such a way that it cannot be 
easily used in the illicit production of a controlled substance; and
    (2) The listed chemical or chemicals contained in the chemical 
mixture cannot be readily recovered.
    Any manufacturer seeking an exemption for a chemical mixture, not 
automatically exempt under 21 CFR 1310.12, may apply to the 
Administrator by submitting an application for exemption which contains 
the following information:
    (1) The name, address, and registration number, if any, of the 
applicant;
    (2) The date of the application;
    (3) The exact trade name(s) of the applicant's chemical mixture;
    (4) The complete qualitative and quantitative composition of the 
chemical mixture (including all listed and all non-listed chemicals); 
or if a group of mixtures, the concentration range for the listed 
chemical and a listing of all non-listed chemicals with respective 
concentration ranges.
    (5) The chemical and physical properties of the mixture and how 
they differ from the properties of the listed chemical or chemicals; 
and if a group of mixtures, how the group's properties differ from the 
properties of the listed chemical.
    (6) A statement that the applicant believes justifies an exemption 
for the chemical mixture or group of mixtures. The statement must 
explain how the chemical mixture(s) meets the exemption criteria.
    (7) A statement that the applicant accepts the right of the 
Administrator to terminate exemption from regulation for the chemical 
mixture(s) granted exemption under 21 CFR 1310.13.
    (8) The identification of any information on the application that 
is considered by the applicant to be a trade secret or confidential and 
entitled to protection under U.S. laws restricting the public 
disclosure of such information.
    The Administrator may require the applicant to submit such 
additional documents or written statements of fact relevant to the 
application that he deems necessary for determining if the application 
should be granted.
    21 CFR 1310.13 further specifies that within 30 days after the 
receipt of an application for an exemption, the Administrator will 
notify the applicant of acceptance or rejection of the application. If 
the application is not accepted, an explanation will be provided. The 
Administrator is not required to accept an application if any 
information required pursuant to 21 CFR 1310.13 is lacking or not 
readily understood. The applicant may, however, amend the application 
to meet the requirements of this section.
    If the exemption is granted, the applicant shall be notified in 
writing and the Administrator shall issue, and publish in the Federal 
Register, an order on the application. This order shall specify the 
date on which it shall take effect. The Administrator shall permit any 
interested person to file written comments on or objections to the 
order. If any comments or objections raise significant issues regarding 
any findings of fact or conclusions of law upon which the order is 
based, the Administrator may suspend the effectiveness of the order 
until she has reconsidered the application in light of the comments and 
objections filed. Thereafter, the Administrator shall reinstate, 
terminate, or amend the original order as deemed appropriate.
    The Administrator may, at any time, terminate or modify an 
exemption for any product (21 CFR 1310.13(e)). In terminating or 
modifying an exemption, the Administrator shall issue, and publish in 
the Federal Register, notification of the removal of an exempt product 
or group of exempt products for which evidence of diversion has been 
found. This order shall specify the date on which the termination of 
exemption shall take effect. The Administrator shall permit any 
interested party to file written comments on or objections to the order 
within 60 days of the date of publication of the order in the Federal 
Register. If any such comments or objections raise significant issues 
regarding any finding of fact or conclusion of law upon which the order 
is based, the Administrator may suspend the effectiveness of the order 
until he has reconsidered the order in light of comments and objections 
filed. Thereafter, the Administrator shall reinstate, terminate, or 
amend the original order as determined appropriate.
    A manufacturer of an exempted chemical mixture shall notify DEA, in 
writing, of any change in the quantitative or qualitative composition 
of a chemical mixture that has been granted an exemption by application 
(21 CFR 1310.13(g)). Changes include those greater than the range of 
concentration given in the application or that remove non-listed 
chemical(s) given in the application as part of the formulation. A new 
application will be required only if reformulation results in a new 
product having a different commercial application or can no longer be 
defined as part of a group of exempted chemicals. DEA must be notified 
of reformulation at least 30 days in advance of marketing the 
reformulated mixture. For a change in name or other designation, code, 
or any identifier, a written notification is required. DEA must be 
notified of any changes at least 60 days in advance of the effective 
date for the change.
    Each manufacturer seeking exemption must apply for such an 
exemption (21 CFR 1310.13(h)) to ensure that each manufacturer's 
product warrants an exemption and is not subject to diversion. A 
formulation granted exemption by publication in the Federal Register 
will not be exempted for all manufacturers.

Redelegation of Authority

    The Administrator has redelegated the authority to change the 
listing of exempt chemical mixtures to the Deputy

[[Page 53869]]

Administrator, Drug Enforcement Administration, pursuant to 28 CFR 
0.104, Appendix to Subpart R. The current Table of Exempt Chemical 
Mixtures 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.

Regulatory Action

    Therefore, each of the 21 chemical mixtures for which DEA has 
received applications for exemptions from their manufacturers are 
designated as exempt chemical mixtures for the purposes set forth in 21 
CFR 1310.13 and are exempted by the Administrator from application of 
sections 302, 303, 310, 1007, and 1008 of the Act (21 U.S.C. 822, 823, 
830, 957 and 958).
    DEA is updating the table in 21 CFR 1310.13(i) to include each of 
these exempt chemical mixtures.

Regulatory Certifications

Regulatory Flexibility Act

    The Deputy 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 
Exempt Chemical Mixture status for these products reduces the 
regulatory requirements for distribution of these materials.

Executive Order 12866

    The Deputy 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 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.

Administrative Procedure Act

    An agency may find good cause to exempt a rule from prior public 
notice provisions of the Administrative Procedure Act (5 U.S.C. 
553(b)(B)), if it is determined to be unnecessary, impracticable, or 
contrary to the public interest. DEA finds that it is contrary to the 
public interest to seek public comment prior to making the exemption of 
these 21 chemical mixtures from the requirements of the CSA effective. 
Each of these manufacturers has received a DEA letter granting exempted 
status for the specific products on the date shown in the attached 
table. This regulatory action conforms DEA regulations to the 
exemptions previously issued.

List of Subjects in 21 CFR Part 1310

    Administrative practice and procedure, Drug traffic control, Listed 
chemicals.

0
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 0.100), and redelegated to the Deputy Administrator, 
Drug Enforcement Administration, the Deputy Administrator hereby amends 
21 CFR part 1310 as set forth below.

PART 1310--RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN 
MACHINES

0
1. The authority citation for part 1310 continues to read as follows:

    Authority: 21 U.S.C. 802, 827(h), 830, 871(b), 890.

0
2. In Sec.  1310.13(i), the table is revised to read as follows:

Sec.  1310.13  Exemption of chemical mixtures; application.

* * * * *
    (i) * * *

                                            Exempt Chemical Mixtures
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            Manufacturer                         Product name \1\                      Form              Date
----------------------------------------------------------------------------------------------------------------
Cerilliant Corporation..............  1R,2S(-)-Ephedrine hydrochloride 1.0    Liquid...............     8/2/2007
                                       mg/ml as free base in one of: 1,2-
                                       dimethoxyethane, acetonitrile,
                                       acetonitrile: water (>= 50%
                                       acetonitrile), dimethylformamide,
                                       ethylene glycol, isopropanol,
                                       methanol, methanol/water (50:50),
                                       methanol/dimethyl sulfoxide (80:20),
                                       methylene chloride, or
                                       tetrahydrofuran.
Cerilliant Corporation..............  1S,2R(+)-Ephedrine-D3 hydrochloride     Liquid...............     8/2/2007
                                       0.1 mg/ml as free base in one of: 1,2-
                                       dimethoxyethane, acetonitrile,
                                       acetonitrile: water (>= 50%
                                       acetonitrile), dimethylformamide,
                                       ethylene glycol, isopropanol,
                                       methanol, methanol/water (50:50),
                                       methanol/dimethyl sulfoxide (80:20),
                                       methylene chloride, or
                                       tetrahydrofuran.

[[Page 53870]]

Cerilliant Corporation..............  1S,2R(+)-Ephedrine-D3 hydrochloride     Liquid...............     8/2/2007
                                       1.0 mg/ml as free base in one of: 1,2-
                                       dimethoxyethane, acetonitrile,
                                       acetonitrile: water (>= 50%
                                       acetonitrile), dimethylformamide,
                                       ethylene glycol, isopropanol,
                                       methanol, methanol/water (50:50),
                                       methanol/dimethyl sulfoxide (80:20),
                                       methylene chloride, or
                                       tetrahydrofuran.
Cerilliant Corporation..............  1S,2R(+)-Ephedrine hydrochloride 1.0    Liquid...............     8/2/2007
                                       mg/ml as free base in one of: 1,2-
                                       dimethoxyethane, acetonitrile,
                                       acetonitrile: water (>= 50%
                                       acetonitrile), dimethylformamide,
                                       ethylene glycol, isopropanol,
                                       methanol, methanol/water (50:50),
                                       methanol/dimethyl sulfoxide (80:20),
                                       methylene chloride, or
                                       tetrahydrofuran.
Cerilliant Corporation..............  Pseudoephedrine-D3 hydrochloride 0.1    Liquid...............     8/2/2007
                                       mg/ml as free base in one of: 1,2-
                                       dimethoxyethane, acetonitrile,
                                       acetonitrile: water (>= 50%
                                       acetonitrile), dimethylformamide,
                                       ethylene glycol, isopropanol,
                                       methanol, methanol/water (50:50),
                                       methanol/dimethyl sulfoxide (80:20),
                                       methylene chloride, or
                                       tetrahydrofuran.
Cerilliant Corporation..............  R,R(-)-Pseudoephedrine 1.0 mg/ml as     Liquid...............     8/2/2007
                                       free base in one of: 1,2-
                                       dimethoxyethane, acetonitrile,
                                       acetonitrile: water (>= 50%
                                       acetonitrile), dimethylformamide,
                                       ethylene glycol, isopropanol,
                                       methanol, methanol/water (50:50),
                                       methanol/dimethyl sulfoxide (80:20)
                                       methylene chloride, or
                                       tetrahydrofuran.
Cerilliant Corporation..............  S,S(+)-Pseudoephedrine 1.0 mg/ml as     Liquid...............     8/2/2007
                                       free base in one of: 1,2-
                                       dimethoxyethane, acetonitrile,
                                       acetonitrile: water (>= 50%
                                       acetonitrile), dimethylformamide,
                                       ethylene glycol, isopropanol,
                                       methanol, methanol/water (50:50),
                                       methanol/dimethyl sulfoxide (80:20),
                                       methylene chloride, or
                                       tetrahydrofuran.
E.I. DuPont deNemours & Co..........  RC-5156...............................  Liquid...............    4/22/2005
E.I. DuPont deNemours & Co..........  VH-6037...............................  Liquid...............    4/22/2005
Hawthorne Products, Inc.............  Sole Pack Hoof Dressing...............  Paste................    8/14/2007
Hawthorne Products, Inc.............  Sole Pack Hoof Packing................  Paste................    8/14/2007
Quality Assurance Service             10 to 1000 nanograms per milliliter of  Liquid...............    9/26/2007
 Corporation.                          ephedrine in blood, serum, or urine.
Quality Assurance Service             10 to 1000 nanograms per milliliter of  Liquid...............    9/26/2007
 Corporation.                          pseudoephedrine in blood, serum, or
                                       urine.
Quality Assurance Service             10 to 1000 nanograms per milliliter of  Liquid...............    9/26/2007
 Corporation.                          phenylpropanolamine in blood, serum,
                                       or urine.
Reichhold, Inc......................  Beckosol[supreg] 12021-00 AA-200, IA-   Liquid...............    5/05/2005
                                       441, P531-T.
Reichhold, Inc......................  Urotuf[supreg] L06-30S, F78-50T.......  Liquid...............    5/05/2005
Reichhold, Inc......................  Beckosol AA-220.......................  Liquid...............    6/14/2005
Waterbury Companies, Inc............  Waterbury 332500......................  Liquid...............    4/11/2005
Waterbury Companies, Inc............  Waterbury 332762......................  Liquid...............    4/11/2005
Waterbury Companies, Inc............  Waterbury 332400......................  Liquid...............    4/11/2005
Waterbury Companies, Inc............  Waterbury 346201......................  Liquid...............    4/11/2005
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\1\ Designate product line if a group.

    Dated: August 20, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-21778 Filed 9-1-10; 8:45 am]
BILLING CODE 4410-09-P
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