Schedules of Controlled Substances; Table of Excluded Nonnarcotic Products: Nasal Decongestant Inhalers Manufactured by Classic Pharmaceuticals LLC, 44281-44284 [E9-20768]

Download as PDF Federal Register / Vol. 74, No. 166 / Friday, August 28, 2009 / Rules and Regulations Where: Tj = Average time spent in failure condition j (in hours). Pj = Probability of occurrence of failure mode j (per hour). Note: If Pj is greater than 10¥3 per flight hour, then a 1.5 factor of safety must be V′ = Clearance speed as defined by § 25.629(b)(2). V″ = Clearance speed as defined by § 25.629(b)(1). Qj = (Tj)(Pj) Where: Tj = Average time spent in failure condition j (in hours). Pj = Probability of occurrence of failure mode j (per hour). jlentini on DSKJ8SOYB1PROD with RULES Note: If Pj is greater than 10¥3 per flight hour, then the flutter clearance speed must not be less than V’’. (vi) Freedom from aeroelastic instability must also be shown, up to V′ in Figure 3 above, for any probable system-failure condition combined with any damage required or selected for investigation by § 25.571(b). (3) Consideration of certain failure conditions may be required by other subparts of part 25 regardless of calculated system reliability. Where analysis shows the probability of these failure conditions to be less than 10¥9, criteria other than those specified in this paragraph may be used for structural substantiation to show continued safe flight and landing. (d) Failure indications. For systemfailure detection and indication, the following apply: (1) The system must be checked for failure conditions, not extremely improbable, that degrade the structural capability below the level required by part 25, or that significantly reduce the reliability of the remaining system. To the extent practicable, these failures must be detected and annunciated to the flight crew before flight. Certain VerDate Nov<24>2008 16:25 Aug 27, 2009 Jkt 217001 applied to all limit-load conditions specified in Subpart C. (iii) For residual-strength substantiation, the airplane must be able to withstand two-thirds of the ultimate loads defined in subparagraph (c)(2)(ii). (iv) If the loads induced by the failure condition have a significant effect on elements of the control system, such as mechanical and hydraulic components, may use special periodic inspections, and electronic components may use daily checks, in lieu of warning systems, to achieve the objective of this requirement. These certificationmaintenance requirements must be limited to components that are not readily detectable by normal warning systems, and where service history shows that inspections provide an adequate level of safety. (2) The existence of any failure condition, not extremely improbable, during flight, that could significantly affect the structural capability of the airplane and for which the associated reduction in airworthiness can be minimized by suitable flight limitations, must be signaled to the flight crew. Failure conditions that result in a factor of safety between the airplane strength and the loads of Subpart C below 1.25, or flutter margins below V″, must be signaled to the crew during flight. (e) Dispatch with known failure conditions. If the airplane is to be dispatched in a known system-failure condition that affects structural performance, or affects the reliability of the remaining system to maintain structural performance, then the provisions of § 25.302 must be met for the dispatched condition and for subsequent failures. Flight limitations and expected operational limitations may be taken into account in establishing Qj as the combined probability of being in the dispatched failure condition and the subsequent failure condition for the safety margins PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 fatigue or damage tolerance, then their effects must be taken into account. (v) Freedom from aeroelastic instability must be shown up to a speed determined from Figure 3. Flutterclearance speeds V′ and V″ may be based on the speed limitation specified for the remainder of the flight using the margins defined by § 25.629(b). in Figures 2 and 3. These limitations must be such that the probability of being in this combined failure state, and then subsequently encountering limitload conditions, is extremely improbable. No reduction in these safety margins is allowed if the subsequent system-failure rate is greater than 10¥3 per hour. Issued in Renton, Washington, on August 20, 2009. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E9–20697 Filed 8–27–09; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA–329I] RIN 1117–AB23 Schedules of Controlled Substances; Table of Excluded Nonnarcotic Products: Nasal Decongestant Inhalers Manufactured by Classic Pharmaceuticals LLC AGENCY: Drug Enforcement Administration (DEA), Department of Justice. ACTION: Interim rule with request for comments. SUMMARY: Under this Interim Rule, the Drug Enforcement Administration (DEA) is updating the Table of Excluded E:\FR\FM\28AUR1.SGM 28AUR1 ER28AU09.088</GPH> Qj = (Tj)(Pj) 44281 44282 Federal Register / Vol. 74, No. 166 / Friday, August 28, 2009 / Rules and Regulations Nonnarcotic Products found in 21 CFR 1308.22 to include the Nasal Decongestant Inhaler/Vapor Inhaler (containing 50 mg Levmetamfetamine) manufactured by Classic Pharmaceuticals LLC and marketed under various private labels (to include the ‘‘Premier Value’’ and ‘‘Kroger’’ labels). This nonnarcotic drug product, which may be lawfully sold over the counter without a prescription under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301), is excluded from provisions of the Controlled Substances Act (CSA) pursuant to 21 U.S.C. 811(g)(1). Any interested person may file comments or objections to this order on or before October 27, 2009. If any such comments or objections raise significant issues regarding any finding of fact or conclusion of law upon which this order is based, the Deputy Assistant Administrator shall immediately suspend the effectiveness of this order until he may reconsider the application in light of the comments or objections filed. Thereafter, the Deputy Assistant Administrator shall reinstate, revoke, or amend his original order as he determines appropriate. DATES: This rulemaking shall become effective on August 28, 2009. Written comments must be postmarked and electronic comments must be submitted on or before October 27, 2009. 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. To ensure proper handling of comments, please reference ‘‘Docket No. DEA–329I’’ on all written and electronic correspondence. Written comments sent via regular or express mail should be sent to 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 format other than those specifically listed here. jlentini on DSKJ8SOYB1PROD with RULES ADDRESSES: VerDate Nov<24>2008 16:25 Aug 27, 2009 Jkt 217001 Please note that DEA is requesting that electronic comments be submitted before midnight Eastern time on the day the comment period closes because 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, 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: 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 and in the Drug Enforcement Administration’s public docket. 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 online or made available in the public docket. 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 PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 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. Background The Controlled Substances Act (CSA) under 21 U.S.C. 811(g)(1) states that the Attorney General shall by regulation exclude any nonnarcotic drug which contains a controlled substance from the application of the CSA, if such drug may, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), be lawfully sold over the counter without a prescription. This authority has been delegated to the Administrator of DEA and redelegated to the Deputy Assistant Administrator of the Office of Diversion Control pursuant to 28 CFR 0.100 and Title 28, Part 0, Appendix to Subpart R, 7(g), respectively. Such exclusions apply only to nonnarcotic products and are only granted following suitable application to the DEA per the provisions of 21 CFR 1308.21. The current Table of Excluded Nonnarcotic Products found in 21 CFR 1308.22 lists those products that have been granted excluded status. Pursuant to the application process of 21 CFR 1308.21, DEA received application for exclusion from Classic Pharmaceuticals, LLC, the manufacturer of a Nasal Decongestant Inhaler/Vapor Inhaler which contains the schedule II controlled substance Levmetamfetamine. This inhaler is sold over the counter under various private labels (such as the ‘‘Premier Value’’ label of the Chain Drug Consortium, Boca Raton, Florida, and ‘‘The Kroger’’ label by The Kroger Company of Cincinnati, OH). Based on the application and other information received, including the quantitative composition of the substance and labeling and packaging information, DEA has determined that this product (sold under various private labels) may, under the Federal Food, Drug, and Cosmetic Act, be lawfully sold over the counter without a prescription (21 U.S.C. 811(g)(1)). The Deputy Assistant Administrator finds that this product meets the criteria for exclusion from the CSA in accordance with 21 U.S.C. 811(g)(1). Note that this exclusion only applies to the finished drug product in the form of an inhaler (in the exact formulation detailed in the application for exclusion), which is lawfully sold under the Federal Food, Drug, and Cosmetic Act. The extraction or removal of the E:\FR\FM\28AUR1.SGM 28AUR1 44283 Federal Register / Vol. 74, No. 166 / Friday, August 28, 2009 / Rules and Regulations active ingredient (Levmetamfetamine) from the inhaler shall negate this exclusion and result in the possession of a schedule II controlled substance. This rulemaking adds Classic Pharmaceuticals, LLC product containing 50 mg Levmetamfetamine in a Nasal Decongestant Inhaler/Vapor Inhaler and marketed under various private labels to the list of excluded nonnarcotic products contained in 21 CFR 1308.22. Effective August 28, 2009 this product is excluded from CSA regulatory provisions. Any interested person may file written comments or objections to this order on or before October 27, 2009. If any such comments or objections raise significant issues regarding any finding of fact or conclusion of law upon which this order is based, the Deputy Assistant Administrator shall immediately suspend the effectiveness of this order until he may reconsider the application in light of the comments or objections filed. Thereafter, the Deputy Assistant Administrator shall reinstate, revoke, or amend his original order as he determines appropriate. 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). This rule will not have a significant economic impact on a substantial number of small entities. This rule adds a product to the list of products excluded from the requirements of the CSA. Executive Order 12866 The Deputy Assistant Administrator certifies that this rulemaking has been drafted in accordance with the principles in Executive Order 12866 Section 1(b). It has been determined that this is not ‘‘a significant regulatory action.’’ As discussed previously, based on the information received by the manufacturer of the product in question, DEA has determined that this product may, under the Federal Food, Drug, and Cosmetic Act, be lawfully sold over the counter without a prescription. Executive Order 12988 This regulation meets the applicable standards set forth in Sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform. 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 Congressional Review Act/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 cost 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. Administrative Procedure Act An agency may find good cause to exempt a rule from certain provisions of the Administrative Procedure Act (5 U.S.C. 553), including notice of proposed rulemaking and the opportunity for public comment, if it is determined to be unnecessary, impracticable, or contrary to the public interest. DEA finds that it is unnecessary and impracticable to seek public comment prior to making the exclusion of this nonnarcotic product from the requirements of the CSA effective. DEA has no discretion in its determination of whether the product may, under the Federal Food, Drug, and Cosmetic Act, be lawfully sold over the counter without a prescription. The Administrative Procedure Act permits an agency to make a rule effective upon date of publication if it is ‘‘a substantive rule which grants or recognizes an exemption or relieves a restriction’’ (5 U.S.C. 553(d)(1)). Since this rule excludes a nonnarcotic drug product from the provisions of the CSA, DEA finds that it meets the criteria set forth in 5 U.S.C. 553(d)(1) for an exception to the effective date requirement. List of Subjects in 21 CFR Part 1308 Administrative practice and procedure, Drug traffic control, Narcotics, Prescription drugs. For the reasons set out above, 21 CFR Part 1308 is amended as follows: ■ PART 1308—SCHEDULES OF CONTROLLED SUBSTANCES 1. The authority citation for part 1308 continues to read as follows: ■ Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted. 2. Section 1308.22 is amended by adding to the table, in alphabetical order, the product listed below: ■ § 1308.22 Excluded substances. * * * * * EXCLUDED NONNARCOTIC PRODUCTS Company Trade name NDC code jlentini on DSKJ8SOYB1PROD with RULES * * * Classic Pharmaceuticals LLC Nasal Decongestant Inhaler/ Vapor Inhaler. * VerDate Nov<24>2008 * 16:25 Aug 27, 2009 * Jkt 217001 PO 00000 Form Controlled substance * * IN ................. * Levmetamfetamine (l-Desoxyephedrine). * Frm 00015 Fmt 4700 * Sfmt 4700 E:\FR\FM\28AUR1.SGM * 28AUR1 (mg or mg/ml) * 50.00 * 44284 Federal Register / Vol. 74, No. 166 / Friday, August 28, 2009 / Rules and Regulations Dated: August 21, 2009. Joseph T. Rannazzisi, Deputy Assistant Administrator, Deputy Chief of Operations, Office of Diversion Control. [FR Doc. E9–20768 Filed 8–27–09; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 24 CFR Part 5 [Docket No. FR–5331–F–01] RIN 2501–AD47 Use of Project Labor Agreements for Federal Construction Projects Office of the Secretary, HUD. Final rule. AGENCY: jlentini on DSKJ8SOYB1PROD with RULES ACTION: SUMMARY: This final rule removes a HUD regulation that prohibits the use of project labor agreements in HUDassisted construction contracts. Executive Order 13502, entitled ‘‘Use of Project Labor Agreements for Federal Construction Projects,’’ and signed by President Obama on February 6, 2009, revoked Executive Order 13202, which had prohibited federal agencies from requiring or prohibiting project labor agreements as a condition for award of any federally funded contract or subcontract for construction. Executive Order 13502, which applies to direct federal procurement of construction, encourages federal agencies to consider requiring the use of project labor agreements in connection with federally procured large-scale construction projects. The Executive Order also allows the use of project labor agreements in circumstances not covered by the Order, including projects receiving federal financial assistance. In a previously published Federal Register notice pertaining to HUD’s Fiscal Year 2009 (FY 2009) funding, participants in HUD programs and prospective recipients of HUD funds were notified of the issuance of Executive Order 13502, of its removal of the restrictions on the use of project labor agreements, and of the invalidity of the HUD regulation promulgated to enforce the earlier Executive Order. With the revocation of Executive Order 13202, there is no longer a legal basis for HUD’s regulation that implemented that executive order with respect to HUDassisted projects. Therefore, this rule removes the regulation from the Code of Federal Regulations. DATES: Effective Date: September 28, 2009. FOR FURTHER INFORMATION CONTACT: Camille E. Acevedo, Associate General VerDate Nov<24>2008 16:25 Aug 27, 2009 Jkt 217001 Counsel for Legislation and Regulations, Office of General Counsel, Department of Housing and Urban Development, 451 7th Street, SW., Room 10282, Washington, DC 20410; telephone number 202–402–5132 (this is not a tollfree number). Persons with hearing or speech impairments may access this number through TTY by calling the tollfree Federal Information Relay Service at 800–877–8339. SUPPLEMENTARY INFORMATION: I. Background—Executive Order 13502, ‘‘Use of Project Labor Agreements for Federal Construction Projects’’ Executive Order 13502, entitled ‘‘Use of Project Labor Agreements for Federal Construction Projects,’’ and signed by President Barack Obama on February 6, 2009, while directed to federal agency procurement of construction, also allows federal agencies to consider requiring the use of project labor agreements in connection with largescale federally assisted construction projects. (Executive Order 13502 was subsequently published in the Federal Register on February 11, 2009 (74 FR 6985).) The Executive Order revokes Executive Order 13202, ‘‘Preservation of Open Competition and Government Neutrality towards Government Contractors’ Labor Relations on Federal and Federally Funded Construction Projects,’’ which prohibited federal agencies from requiring or prohibiting project labor agreements as a condition for award of any federally funded contract or subcontract for construction.1 In order to bind participants in HUD programs to the provisions of Executive Order 13202, HUD established regulations at 24 CFR 5.108 that barred recipients of HUD funds from requiring or prohibiting project labor agreements in their procurements using HUD funds. The HUD regulations applied to HUDassisted construction contracts. Construction contracts awarded directly by HUD were covered separately by provisions in the government-wide Federal Acquisition Regulation (FAR). Executive Order 13502 restores to federal agencies the discretion to determine when project labor agreements may be appropriate and beneficial in federally assisted construction projects, through the revocation of Executive Order 13202. As a result of the revocation, Executive 1 (Executive Order 13202 was signed by President George W. Bush on February 17, 2001 (published in the Federal Register on February 22, 2001 (66 FR 11225)) and later amended by Executive Order 13208, signed by President Bush on April 6, 2001 (published in the Federal Register on April 11, 2001 (66 FR 18717)). PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 Order 13502 also removes the prohibition on recipients of HUD funds from requiring the use of project labor agreements in their procurements. Because the foundation for HUD’s regulation in 24 CFR 5.108 was the prior Executive Order, which has been revoked, the rule no longer has effect. Accordingly, in an update of requirements applicable to HUD funding for FY 2009, published in the Federal Register on April 16, 2009 (74 FR 17685), HUD notified prospective recipients and participants in HUD programs that the new Executive Order revoked Executive Order 13202 and that the regulation in 24 CFR 5.108 was no longer in effect. Executive Order 13502 was issued to address the challenges to efficient and timely procurement presented to the federal government by large-scale construction projects. Because construction employers often do not have a permanent workforce, it can be difficult for them to predict labor costs when bidding on contracts and to ensure a steady stream of labor on contracts being performed. Often, multiple employers are involved at a single location, and a labor dispute concerning even one employer can delay an entire project. A lack of coordination between employers or uncertainties about the terms and conditions of employment of various groups of workers can create friction and disputes in the absence of an agreed-upon resolution mechanism. Project labor agreements can present a means for addressing these problems by providing structure and stability to large-scale construction projects, thereby promoting the efficient and expeditious completion of federal construction contracts. Executive Order 13502 declares that it is the policy of the federal government to encourage the executive agencies to consider requiring the use of project labor agreements in connection with large-scale construction projects in order to promote economy and efficiency in federal procurement. The Executive Order, however, does not require an executive agency to use a project labor agreement on any construction project, nor does it preclude the use of a project labor agreement in circumstances not covered by the Order, including leasehold arrangements and projects receiving federal financial assistance. The Executive Order also does not require contractors or subcontractors to enter into a project labor agreement with any particular labor organization. E:\FR\FM\28AUR1.SGM 28AUR1

Agencies

[Federal Register Volume 74, Number 166 (Friday, August 28, 2009)]
[Rules and Regulations]
[Pages 44281-44284]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-20768]


=======================================================================
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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-329I]
RIN 1117-AB23


Schedules of Controlled Substances; Table of Excluded Nonnarcotic 
Products: Nasal Decongestant Inhalers Manufactured by Classic 
Pharmaceuticals LLC

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

ACTION: Interim rule with request for comments.

-----------------------------------------------------------------------

SUMMARY: Under this Interim Rule, the Drug Enforcement Administration 
(DEA) is updating the Table of Excluded

[[Page 44282]]

Nonnarcotic Products found in 21 CFR 1308.22 to include the Nasal 
Decongestant Inhaler/Vapor Inhaler (containing 50 mg Levmetamfetamine) 
manufactured by Classic Pharmaceuticals LLC and marketed under various 
private labels (to include the ``Premier Value'' and ``Kroger'' 
labels). This nonnarcotic drug product, which may be lawfully sold over 
the counter without a prescription under the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301), is excluded from provisions of the 
Controlled Substances Act (CSA) pursuant to 21 U.S.C. 811(g)(1).
    Any interested person may file comments or objections to this order 
on or before October 27, 2009. If any such comments or objections raise 
significant issues regarding any finding of fact or conclusion of law 
upon which this order is based, the Deputy Assistant Administrator 
shall immediately suspend the effectiveness of this order until he may 
reconsider the application in light of the comments or objections 
filed. Thereafter, the Deputy Assistant Administrator shall reinstate, 
revoke, or amend his original order as he determines appropriate.

DATES: This rulemaking shall become effective on August 28, 2009. 
Written comments must be postmarked and electronic comments must be 
submitted on or before October 27, 2009. 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-329I'' on all written and electronic correspondence. 
Written comments sent via regular or express mail should be sent to 
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 format 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 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, 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: 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 
and in the Drug Enforcement Administration's public docket. 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 online or made available in the 
public docket.
    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 paragraph.

Background

    The Controlled Substances Act (CSA) under 21 U.S.C. 811(g)(1) 
states that the Attorney General shall by regulation exclude any 
nonnarcotic drug which contains a controlled substance from the 
application of the CSA, if such drug may, under the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.), be lawfully sold over the 
counter without a prescription. This authority has been delegated to 
the Administrator of DEA and redelegated to the Deputy Assistant 
Administrator of the Office of Diversion Control pursuant to 28 CFR 
0.100 and Title 28, Part 0, Appendix to Subpart R, 7(g), respectively.
    Such exclusions apply only to nonnarcotic products and are only 
granted following suitable application to the DEA per the provisions of 
21 CFR 1308.21. The current Table of Excluded Nonnarcotic Products 
found in 21 CFR 1308.22 lists those products that have been granted 
excluded status.
    Pursuant to the application process of 21 CFR 1308.21, DEA received 
application for exclusion from Classic Pharmaceuticals, LLC, the 
manufacturer of a Nasal Decongestant Inhaler/Vapor Inhaler which 
contains the schedule II controlled substance Levmetamfetamine. This 
inhaler is sold over the counter under various private labels (such as 
the ``Premier Value'' label of the Chain Drug Consortium, Boca Raton, 
Florida, and ``The Kroger'' label by The Kroger Company of Cincinnati, 
OH). Based on the application and other information received, including 
the quantitative composition of the substance and labeling and 
packaging information, DEA has determined that this product (sold under 
various private labels) may, under the Federal Food, Drug, and Cosmetic 
Act, be lawfully sold over the counter without a prescription (21 
U.S.C. 811(g)(1)).
    The Deputy Assistant Administrator finds that this product meets 
the criteria for exclusion from the CSA in accordance with 21 U.S.C. 
811(g)(1). Note that this exclusion only applies to the finished drug 
product in the form of an inhaler (in the exact formulation detailed in 
the application for exclusion), which is lawfully sold under the 
Federal Food, Drug, and Cosmetic Act. The extraction or removal of the

[[Page 44283]]

active ingredient (Levmetamfetamine) from the inhaler shall negate this 
exclusion and result in the possession of a schedule II controlled 
substance.
    This rulemaking adds Classic Pharmaceuticals, LLC product 
containing 50 mg Levmetamfetamine in a Nasal Decongestant Inhaler/Vapor 
Inhaler and marketed under various private labels to the list of 
excluded nonnarcotic products contained in 21 CFR 1308.22. Effective 
August 28, 2009 this product is excluded from CSA regulatory 
provisions. Any interested person may file written comments or 
objections to this order on or before October 27, 2009. If any such 
comments or objections raise significant issues regarding any finding 
of fact or conclusion of law upon which this order is based, the Deputy 
Assistant Administrator shall immediately suspend the effectiveness of 
this order until he may reconsider the application in light of the 
comments or objections filed. Thereafter, the Deputy Assistant 
Administrator shall reinstate, revoke, or amend his original order as 
he determines appropriate.

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). This rule will not have a 
significant economic impact on a substantial number of small entities. 
This rule adds a product to the list of products excluded from the 
requirements of the CSA.

Executive Order 12866

    The Deputy Assistant Administrator certifies that this rulemaking 
has been drafted in accordance with the principles in Executive Order 
12866 Section 1(b). It has been determined that this is not ``a 
significant regulatory action.'' As discussed previously, based on the 
information received by the manufacturer of the product in question, 
DEA has determined that this product may, under the Federal Food, Drug, 
and Cosmetic Act, be lawfully sold over the counter without a 
prescription.

Executive Order 12988

    This regulation meets the applicable standards set forth in 
Sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice 
Reform.

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 
Congressional Review Act/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 cost 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 certain 
provisions of the Administrative Procedure Act (5 U.S.C. 553), 
including notice of proposed rulemaking and the opportunity for public 
comment, if it is determined to be unnecessary, impracticable, or 
contrary to the public interest. DEA finds that it is unnecessary and 
impracticable to seek public comment prior to making the exclusion of 
this nonnarcotic product from the requirements of the CSA effective. 
DEA has no discretion in its determination of whether the product may, 
under the Federal Food, Drug, and Cosmetic Act, be lawfully sold over 
the counter without a prescription.
    The Administrative Procedure Act permits an agency to make a rule 
effective upon date of publication if it is ``a substantive rule which 
grants or recognizes an exemption or relieves a restriction'' (5 U.S.C. 
553(d)(1)). Since this rule excludes a nonnarcotic drug product from 
the provisions of the CSA, DEA finds that it meets the criteria set 
forth in 5 U.S.C. 553(d)(1) for an exception to the effective date 
requirement.

List of Subjects in 21 CFR Part 1308

    Administrative practice and procedure, Drug traffic control, 
Narcotics, Prescription drugs.

0
For the reasons set out above, 21 CFR Part 1308 is amended as follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
1. The authority citation for part 1308 continues to read as follows:

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

0
2. Section 1308.22 is amended by adding to the table, in alphabetical 
order, the product listed below:

Sec.  1308.22  Excluded substances.

* * * * *

                                          Excluded Nonnarcotic Products
----------------------------------------------------------------------------------------------------------------
                                                                                    Controlled
           Company               Trade name       NDC code           Form           substance      (mg or mg/ml)
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Classic Pharmaceuticals LLC.  Nasal            ..............  IN..............  Levmetamfetamin           50.00
                               Decongestant                                       e (l-
                               Inhaler/Vapor                                      Desoxyephedrin
                               Inhaler.                                           e).
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------



[[Page 44284]]

    Dated: August 21, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Deputy Chief of Operations, Office of 
Diversion Control.
[FR Doc. E9-20768 Filed 8-27-09; 8:45 am]
BILLING CODE 4410-09-P
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