Additions to Listing of Exempt Chemical Mixtures, 4584-4587 [2020-00667]

Download as PDF 4584 Federal Register / Vol. 85, No. 17 / Monday, January 27, 2020 / Rules and Regulations AIRAC date 27-Feb-20 27-Feb-20 27-Feb-20 27-Feb-20 27-Feb-20 27-Feb-20 27-Feb-20 27-Feb-20 State City Airport Mid-Carolina Rgnl ......... Mid-Carolina Rgnl ......... Mid-Carolina Rgnl ......... Deming Muni ................ Deming Muni ................ Deming Muni ................ Kyle-Oakley Field ......... Youngstown Elser Metro. Lebanon SpringfieldGeorge Hoerter Field. Reno/Stead ................... Reno/Stead ................... Tri-State Steuben County. Williamsburg-Whitley County. ..... ..... ..... ..... ..... ..... ..... ..... NC NC NC NM NM NM KY OH Salisbury .......... Salisbury .......... Salisbury .......... Deming ............ Deming ............ Deming ............ Murray ............. Youngstown ..... 27-Feb-20 ..... KY Springfield ........ 27-Feb-20 ..... 27-Feb-20 ..... 27-Feb-20 ..... NV NV IN Reno ................ Reno ................ Angola ............. 27-Feb-20 ..... KY Williamsburg .... BILLING CODE 4910–13–P Drug Enforcement Administration 21 CFR Part 1310 [Docket No. DEA–505F] RIN 1117–ZA05 Additions to Listing of Exempt Chemical Mixtures Drug Enforcement Administration, Department of Justice. ACTION: Direct final rule. AGENCY: Under this direct final rule, the Drug Enforcement Administration (DEA) is updating the Table of Exempt Chemical Mixtures to include the listing of 15 additional preparations. This action is in response to DEA’s review of new applications for exemption. Having reviewed applications and relevant information, DEA finds that these preparations meet the applicable exemption criteria. Therefore, these products are exempted from the application of certain provisions of the Controlled Substances Act. DATES: This direct final rule is effective March 27, 2020 without further action, unless adverse comment is received by DEA no later than February 26, 2020. If any comments or objections raise significant issues regarding any findings of fact or conclusions of law upon which the order is based, the DEA will publish a timely withdrawal of the rule in the Federal Register. Written comments must be postmarked and electronic comments must be submitted on or before February 26, 2020. Commenters should be aware that the electronic Federal Docket khammond on DSKJM1Z7X2PROD with RULES SUMMARY: Jkt 250001 12/26/19 12/26/19 12/26/19 1/3/20 1/3/20 1/3/20 12/26/19 12/26/19 RNAV (GPS) RWY 20, Amdt 1B. NDB RWY 20, Amdt 1B. ILS OR LOC RWY 20, Amdt 1B. RNAV (GPS) RWY 4, Amdt 1A. RNAV (GPS) RWY 8, Orig-A. RNAV (GPS) RWY 22, Orig-A. LOC RWY 23, Amdt 2B. VOR–C, Amdt 2B. 9/9177 12/26/19 VOR/DME RWY 11, Amdt 4C. 9/9181 9/9183 9/9187 12/26/19 12/26/19 12/26/19 ILS OR LOC RWY 32, Orig-A. RNAV (GPS) RWY 32, Amdt 1B. RNAV (GPS) RWY 5, Orig-E. 9/9658 12/26/19 LOC RWY 20, Orig-C. To ensure proper handling of comments, please reference ‘‘Docket No. DEA–505F/RIN 1117–ZA05’’ on all correspondence, including any attachments. • Electronic comments: The Drug Enforcement Administration encourages that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or to attach a file for lengthier comments. Please go to http:// www.regulations.gov and follow the online instructions at that site for submitting comments. Upon completion of your submission you will receive a Comment Tracking Number for your comment. Please be aware that submitted comments are not instantaneously available for public view on Regulations.gov. If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment. • Paper comments: Paper comments that duplicate the electronic submission are not necessary and are discouraged. Should you wish to mail a paper comment in lieu of an electronic comment, it should be sent via regular or express mail to: Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152. Telephone: (571) 362–3261. PO 00000 Frm 00016 Fmt 4700 Subject 9/9048 9/9055 9/9056 9/9062 9/9063 9/9065 9/9167 9/9168 ADDRESSES: DEPARTMENT OF JUSTICE 16:03 Jan 24, 2020 FDC date Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period. [FR Doc. 2020–00889 Filed 1–24–20; 8:45 am] VerDate Sep<11>2014 FDC No. Sfmt 4700 Any interested person may file comments or objections to this order, on or before March 27, 2020. 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 DEA will publish a timely withdrawal of the rule in the Federal Register. The Acting Administrator may reconsider the application in light of the comments and objections filed and reinstate, terminate, or amend the original order as deemed appropriate. SUPPLEMENTARY INFORMATION: Posting of Public Comments Please note that all comments received are considered part of the public record and made available for public inspection online at http:// www.regulations.gov. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase ‘‘PERSONAL IDENTIFYING INFORMATION’’ in the first paragraph of your comment. You must also place all the personal identifying information you do not want posted online or made available in the public docket in the first paragraph of your comment and identify what information you want redacted. If you want to submit confidential business information as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase ‘‘CONFIDENTIAL BUSINESS INFORMATION’’ in the first paragraph of your comment. You must also prominently identify confidential E:\FR\FM\27JAR1.SGM 27JAR1 Federal Register / Vol. 85, No. 17 / Monday, January 27, 2020 / Rules and Regulations business information to be redacted within the comment. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be posted on http:// www.regulations.gov. Personal identifying information and confidential business information identified and located as set forth above will be redacted and the comment, in redacted form, will be posted online and placed in the Drug Enforcement Administration’s public docket file. Please note that the Freedom of Information Act applies to all comments received. New Exempt Chemical Mixtures The manufacturers of 15 chemical mixtures listed below have applied for an exemption pursuant to 21 CFR 1310.13. The Drug Enforcement Administration (DEA) has reviewed the applications, as well as any additional information submitted by the respective manufacturers. DEA has found that: (1) Each of these chemical mixtures 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(s) contained in these chemical mixtures cannot be readily recovered. Therefore, DEA has determined that each of the applications should be granted, and previously issued a letter to this effect. This regulatory action conforms DEA regulations to the exemptions previously issued. khammond on DSKJM1Z7X2PROD with RULES Background Under 21 CFR 1310.13(a), the Acting Administrator may, by publication of a Final Rule in the Federal Register, exempt from the application of all or any part of the Controlled Substances Act a chemical mixture consisting of two or more chemical components, at least one of which is not a list I or list II chemical. Each manufacturer must apply for such an exemption (21 CFR 1310.13) to ensure that each manufacturer’s product warrants an exemption by demonstrating that: • The mixture is formulated in such a way that it cannot be easily used in the illicit production of a controlled substance; and • 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 Acting Administrator by submitting an application for exemption which VerDate Sep<11>2014 16:03 Jan 24, 2020 Jkt 250001 contains the information required by 21 CFR 1310.13(c): • The name, address, and registration number, if any, of the applicant; • The date of the application; • The exact trade name(s) of the applicant’s chemical mixture; • 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; • 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; • 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; • A statement that the applicant accepts the right of the Acting Administrator to terminate exemption from regulation for the chemical mixture(s) granted exemption under 21 CFR 1310.13; and • 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 Acting 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. Title 21 CFR 1310.13 further specifies that within a reasonable period of time after the receipt of an application for an exemption, the Acting Administrator will notify the applicant of acceptance or rejection of the application for filing. If the application is not accepted for filing, an explanation will be provided. The Acting 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 Acting 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 Acting PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 4585 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 DEA will publish a timely withdrawal of the rule in the Federal Register. The Acting Administrator may reconsider the application in light of the comments and objections filed and reinstate, terminate, or amend the original order as deemed appropriate. A formulation granted exemption by publication in the Federal Register will not be exempted for all manufacturers. 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. Findings Having considered the information provided in each of the below listed applications, I find that each of the referenced chemical mixtures meets the requirements for exemption under 21 CFR 1310.13(a). Therefore, each of these mixtures is exempt from the application of sections 302, 303, 310, 1007, and 1008 of the Controlled Substances 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 Analyses 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 unnecessary to engage in notice and comment procedures because this rulemaking grants exemptions for the below listed products in accordance with standards set by existing DEA regulations. Each of these manufacturers has previously received a letter from DEA granting exempted status for the specific products. This regulatory action hereby conforms DEA regulations to the exemptions previously considered and issued. Executive Orders 12866, 13563, and 13771, Regulatory Planning and Review, Improving Regulation and Regulatory Review, and Reducing Regulation and Controlling Regulatory Costs This direct final rule was developed in accordance with the principles of E:\FR\FM\27JAR1.SGM 27JAR1 4586 Federal Register / Vol. 85, No. 17 / Monday, January 27, 2020 / Rules and Regulations Executive Orders 12866, 13563, and 13771. Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health, and safety effects; distributive impacts; and equity). Executive Order 13563 is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review as established in Executive Order 12866. Executive Order 12866 classifies a ‘‘significant regulatory action,’’ requiring review by the Office of Management and Budget (OMB), as any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President’s priorities, or the principles set forth in the Executive Order. DEA has determined that this direct final rule is not a ‘‘significant regulatory action’’ under Executive Order 12866, section 3(f). This direct final rule is not an Executive Order 13771 regulatory action pursuant to Executive Order 12866 and the Office of Management and Budget (OMB) guidance.1 khammond on DSKJM1Z7X2PROD with RULES Executive Order 12988, Civil Justice Reform The Acting Administrator further certifies that this rulemaking meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction. Executive Order 13132, Federalism This rulemaking does not have federalism implications warranting the application of Executive Order 13132. The rule does not have substantial 1 Office of Mgmt. & Budget, Exec. Office of The President, Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017 Titled ‘‘Reducing Regulation and Controlling Regulatory Costs’’ (Feb. 2, 2017). VerDate Sep<11>2014 16:03 Jan 24, 2020 Jkt 250001 direct effects on the States, on the relationship between the National Government and the States, or the distribution of power and responsibilities among the various levels of government. Executive Order 13175, Consultation and Coordination With Indian Tribal Governments This rule does not have tribal implications warranting the application of Executive Order 13175. It does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Regulatory Flexibility Act The Acting 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. Unfunded Mandates Reform Act of 1995 In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1501 et seq., DEA has determined that this action will not result in any Federal mandate that may result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted for inflation) in any one year. Therefore, neither a Small Government Agency Plan nor any other action is required under UMRA of 1995. Paperwork Reduction Act of 1995 This action does not impose a new collection of information requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501–3521. This action does not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Congressional Review Act This rule is not a major rule as defined by the Congressional Review Act (CRA), 5 U.S.C. 804. This rule does PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 not result in: An annual effect on the economy of $100,000,000 or more; a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of U.S.-based companies to compete with foreign based companies in domestic and export markets. However, pursuant to the CRA, the DEA has submitted a copy of this direct final rule to both Houses of Congress and to the Comptroller General. List of Subjects in 21 CFR Part 1310 Drug traffic control, Exports, Imports, Reporting and recordkeeping requirements. Under the authority vested in the Attorney General by section 102(39)(A)(vi) of the Act (21 U.S.C. 802(39)(A)(vi)) and delegated to the Administrator of the Drug Enforcement Administration by regulations of the Department of Justice (28 CFR 0.100), the Acting Administrator hereby amends 21 CFR part 1310 as set forth below. PART 1310—RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES; IMPORTATION AND EXPORTATION OF CERTAIN MACHINES 1. The authority citation for part 1310 continues to read as follows: ■ Authority: 21 U.S.C. 802, 827(h), 830, 871(b) 890. 2. In § 1310.13(i), the table is amended by: ■ a. Designating the table as table 1 to paragraph (i); and ■ b. Adding the entries ‘‘GFS Chemicals; WaterMark® Karl-Fisher Reagent, Pyridine-Free Single Solution, 5 mg/ml,’’ ‘‘GFS Chemicals; WaterMark® Karl-Fisher Reagent, 5 mg/ ml Single Solution NON–HAZ,’’ ‘‘GFS Chemicals; WaterMark® Karl-Fisher Reagent, Pyridine-Free Single Solution, 2 mg/ml,’’ ‘‘GFS Chemicals; WaterMark® Karl-Fisher Reagent, 2 mg/ ml Single Solution NON–HAZ,’’ ‘‘GFS Chemicals; WaterMark® Karl-Fisher Reagent, 5 mg/ml, Stabilized, PyridineBased,’’ ‘‘Lord Corporation; Chemlok TS701–52,’’ ‘‘Lord Corporation; Chemlok TS701–53,’’ ‘‘Sigma-Aldrich; Hydranal®-Composite 1,’’ ‘‘SigmaAldrich; Hydranal®-Composite 2,’’ ‘‘Sigma-Aldrich; Hydranal®-Composite 5K,’’ ‘‘Sigma-Aldrich; Hydranal®Composite 5,’’ ‘‘Standard Homeopathic Co.; Baby Cough Syrup,’’ ‘‘Standard Homeopathic Co.; Defend Cough & Cold ■ E:\FR\FM\27JAR1.SGM 27JAR1 4587 Federal Register / Vol. 85, No. 17 / Monday, January 27, 2020 / Rules and Regulations Night,’’ ‘‘Standard Homeopathic Co.; Defend Cough & Cold,’’ and ‘‘Standard Homeopathic Co.; Diarrex’’ in alphabetical order of Manufacturer. § 1310.13 Exemption of chemical mixtures; application. The additions read as follows: * * * (i) * * * * * TABLE 1 TO PARAGRAPH (i)—EXEMPT CHEMICAL MIXTURES Product name 1 Manufacturer * .................................. .................................. .................................. .................................. .................................. * 11/26/2018 11/26/2018 11/26/2018 11/26/2018 11/26/2018 * * Lord Corporation ................................ Lord Corporation ................................ * * * * Chemlok TS701–52 ....................................................................................... Liquid ....... Chemlok TS701–53 ....................................................................................... Liquid ....... * 05/03/2018 05/03/2018 * * Sigma-Aldrich ..................................... Sigma-Aldrich ..................................... Sigma-Aldrich ..................................... Sigma-Aldrich ..................................... Standard Homeopathic Co ................ Standard Homeopathic Co ................ Standard Homeopathic Co ................ Standard Homeopathic Co ................ * * * * Hydranal®-Composite 1 ................................................................................. Hydranal®-Composite 2 ................................................................................. Hydranal®-Composite 5K .............................................................................. Hydranal®-Composite 5 ................................................................................. Baby Cough Syrup ........................................................................................ Defend Cough & Cold Night .......................................................................... Defend Cough & Cold ................................................................................... Diarrex ........................................................................................................... * 1 Designate * WaterMark® WaterMark® WaterMark® WaterMark® WaterMark® * * * * This deviation is effective from 6 a.m. January 27, 2020 through 6 p.m. March 27, 2020. Comments and related material must be received by the Coast Guard on or before March 27, 2020. ADDRESSES: You may submit comments identified by docket number USCG– 2019–0911 using Federal eRulemaking Portal at http://www.regulations.gov. See the ‘‘Public Participation and Request for Comments’’ portion of the SUPPLEMENTARY INFORMATION section for further instructions on submitting comments. DATES: [FR Doc. 2020–00667 Filed 1–24–20; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG–2019–0911] Drawbridge Operation Regulation; Mobile River, Hurricane, AL Coast Guard, DHS. Notice of temporary deviation from regulations; request for comments. ACTION: The Coast Guard has issued a temporary deviation from the operating schedule that governs the CSX Transportation Railroad vertical lift bridge across Mobile River, mile 13.3 near Hurricane, Alabama. This deviation is needed to collect and analyze information on vessel traffic when the bridge tender is moved to a geographically remote centralized control point located in Mobile, AL. The Coast Guard is seeking comments from the public about the impact to vessel traffic generated by this change. SUMMARY: 16:03 Jan 24, 2020 Jkt 250001 If you have questions about this test deviation, call or email Mr. Doug Blakemore, Eighth Coast Guard District Bridge Administrator; telephone (504) 671–2128, email Douglas.A.Blakemore@ uscg.mil. SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: AGENCY: khammond on DSKJM1Z7X2PROD with RULES * * Pyridine-Free Single Solution, 5 mg/ml 5 mg/ml Single Solution NON–HAZ ....... Pyridine-Free Single Solution, 2 mg/ml 2 mg/ml Single Solution NON–HAZ ....... 5 mg/ml, Stabilized, Pyridine-Based ...... * Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid Liquid ....... ....... ....... ....... ....... ....... ....... ....... * 5/29/2013 5/29/2013 5/29/2013 5/29/2013 9/28/2012 9/28/2012 9/28/2012 9/28/2012 * product line if a group. Dated: January 3, 2020. Uttam Dhillon, Acting Administrator. VerDate Sep<11>2014 Karl-Fisher Karl-Fisher Karl-Fisher Karl-Fisher Karl-Fisher * Reagent, Reagent, Reagent, Reagent, Reagent, Approval date ....... ....... ....... ....... ....... GFS GFS GFS GFS GFS * Chemicals Chemicals Chemicals Chemicals Chemicals Form I. Background, Purpose and Legal Basis CSX Railroad has established a central location to operate CSX drawbridges. They have requested to relocate the Mobile River bridge tender to their centralized location in Mobile, AL. This CSX vertical lift bridge is located at Mobile River, mile 13.3, Mobile County, near Hurricane, AL. It has a vertical clearance of 5.5’ in the closed to vessel position. The bridge operates according PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 to 33 CFR 117.5. Mobile River is used primarily by commercial tow and recreational vessels. The bridge opens for vessels about 6 times per day and vessels that do not need the bridge to open may pass. This deviation will last for 60 days. CSX will collect data on all bridge openings to ensure that the remote operations will not impact navigation. CSX will immediately return the tender to the bridge location if there are any system failures or weather conditions that will not allow the bridge tender to operate the bridge from Mobile. The Coast Guard will publish information about this temporary deviation in our Local and Broadcast Notice to Mariners so that mariners are informed of this operating change and our request for comments on the change. In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35. II. Public Participation and Request for Comments We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the E:\FR\FM\27JAR1.SGM 27JAR1

Agencies

[Federal Register Volume 85, Number 17 (Monday, January 27, 2020)]
[Rules and Regulations]
[Pages 4584-4587]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00667]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1310

[Docket No. DEA-505F]
RIN 1117-ZA05


Additions to Listing of Exempt Chemical Mixtures

AGENCY: Drug Enforcement Administration, 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 
to include the listing of 15 additional preparations. This action is in 
response to DEA's review of new applications for exemption. Having 
reviewed applications and relevant information, DEA finds that these 
preparations meet the applicable exemption criteria. Therefore, these 
products are exempted from the application of certain provisions of the 
Controlled Substances Act.

DATES: This direct final rule is effective March 27, 2020 without 
further action, unless adverse comment is received by DEA no later than 
February 26, 2020. If any comments or objections raise significant 
issues regarding any findings of fact or conclusions of law upon which 
the order is based, the DEA will publish a timely withdrawal of the 
rule in the Federal Register.
    Written comments must be postmarked and electronic comments must be 
submitted on or before February 26, 2020. Commenters should be aware 
that the electronic Federal Docket Management System will not accept 
comments after 11:59 p.m. Eastern Time on the last day of the comment 
period.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-505F/RIN 1117-ZA05'' on all correspondence, including 
any attachments.
     Electronic comments: The Drug Enforcement Administration 
encourages that all comments be submitted electronically through the 
Federal eRulemaking Portal, which provides the ability to type short 
comments directly into the comment field on the web page or to attach a 
file for lengthier comments. Please go to http://www.regulations.gov 
and follow the online instructions at that site for submitting 
comments. Upon completion of your submission you will receive a Comment 
Tracking Number for your comment. Please be aware that submitted 
comments are not instantaneously available for public view on 
Regulations.gov. If you have received a Comment Tracking Number, your 
comment has been successfully submitted and there is no need to 
resubmit the same comment.
     Paper comments: Paper comments that duplicate the 
electronic submission are not necessary and are discouraged. Should you 
wish to mail a paper comment in lieu of an electronic comment, it 
should be sent via regular or express mail to: Drug Enforcement 
Administration, Attn: DEA Federal Register Representative/DPW, 8701 
Morrissette Drive, Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Diversion Control 
Division, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, Virginia 22152. Telephone: (571) 362-
3261.

SUPPLEMENTARY INFORMATION: Any interested person may file comments or 
objections to this order, on or before March 27, 2020. 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 DEA 
will publish a timely withdrawal of the rule in the Federal Register. 
The Acting Administrator may reconsider the application in light of the 
comments and objections filed and 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

[[Page 4585]]

business information to be redacted within the comment. If a comment 
has so much confidential business information that it cannot be 
effectively redacted, all or part of that comment may not be posted on 
http://www.regulations.gov. Personal identifying information and 
confidential business information identified and located as set forth 
above will be redacted and the comment, in redacted form, will be 
posted online and placed in the Drug Enforcement Administration's 
public docket file. Please note that the Freedom of Information Act 
applies to all comments received.

New Exempt Chemical Mixtures

    The manufacturers of 15 chemical mixtures listed below have applied 
for an exemption pursuant to 21 CFR 1310.13. The Drug Enforcement 
Administration (DEA) has reviewed the applications, as well as any 
additional information submitted by the respective manufacturers. DEA 
has found that: (1) Each of these chemical mixtures 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(s) contained in these 
chemical mixtures cannot be readily recovered. Therefore, DEA has 
determined that each of the applications should be granted, and 
previously issued a letter to this effect. This regulatory action 
conforms DEA regulations to the exemptions previously issued.

Background

    Under 21 CFR 1310.13(a), the Acting Administrator may, by 
publication of a Final Rule in the Federal Register, exempt from the 
application of all or any part of the Controlled Substances Act a 
chemical mixture consisting of two or more chemical components, at 
least one of which is not a list I or list II chemical. Each 
manufacturer must apply for such an exemption (21 CFR 1310.13) to 
ensure that each manufacturer's product warrants an exemption by 
demonstrating that:
     The mixture is formulated in such a way that it cannot be 
easily used in the illicit production of a controlled substance; and
     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 Acting 
Administrator by submitting an application for exemption which contains 
the information required by 21 CFR 1310.13(c):
     The name, address, and registration number, if any, of the 
applicant;
     The date of the application;
     The exact trade name(s) of the applicant's chemical 
mixture;
     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;
     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;
     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;
     A statement that the applicant accepts the right of the 
Acting Administrator to terminate exemption from regulation for the 
chemical mixture(s) granted exemption under 21 CFR 1310.13; and
     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 Acting 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.
    Title 21 CFR 1310.13 further specifies that within a reasonable 
period of time after the receipt of an application for an exemption, 
the Acting Administrator will notify the applicant of acceptance or 
rejection of the application for filing. If the application is not 
accepted for filing, an explanation will be provided. The Acting 
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 Acting 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 Acting 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 DEA will publish a timely withdrawal of the rule in 
the Federal Register. The Acting Administrator may reconsider the 
application in light of the comments and objections filed and 
reinstate, terminate, or amend the original order as deemed 
appropriate.
    A formulation granted exemption by publication in the Federal 
Register will not be exempted for all manufacturers. 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.

Findings

    Having considered the information provided in each of the below 
listed applications, I find that each of the referenced chemical 
mixtures meets the requirements for exemption under 21 CFR 1310.13(a). 
Therefore, each of these mixtures is exempt from the application of 
sections 302, 303, 310, 1007, and 1008 of the Controlled Substances 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 Analyses

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 unnecessary to 
engage in notice and comment procedures because this rulemaking grants 
exemptions for the below listed products in accordance with standards 
set by existing DEA regulations. Each of these manufacturers has 
previously received a letter from DEA granting exempted status for the 
specific products. This regulatory action hereby conforms DEA 
regulations to the exemptions previously considered and issued.

Executive Orders 12866, 13563, and 13771, Regulatory Planning and 
Review, Improving Regulation and Regulatory Review, and Reducing 
Regulation and Controlling Regulatory Costs

    This direct final rule was developed in accordance with the 
principles of

[[Page 4586]]

Executive Orders 12866, 13563, and 13771. Executive Order 12866 directs 
agencies to assess all costs and benefits of available regulatory 
alternatives and, if regulation is necessary, to select regulatory 
approaches that maximize net benefits (including potential economic, 
environmental, public health, and safety effects; distributive impacts; 
and equity). Executive Order 13563 is supplemental to and reaffirms the 
principles, structures, and definitions governing regulatory review as 
established in Executive Order 12866. Executive Order 12866 classifies 
a ``significant regulatory action,'' requiring review by the Office of 
Management and Budget (OMB), as any regulatory action that is likely to 
result in a rule that may: (1) Have an annual effect on the economy of 
$100 million or more or adversely affect in a material way the economy, 
a sector of the economy, productivity, competition, jobs, the 
environment, public health or safety, or State, local, or tribal 
governments or communities; (2) create a serious inconsistency or 
otherwise interfere with an action taken or planned by another agency; 
(3) materially alter the budgetary impact of entitlements, grants, user 
fees, or loan programs or the rights and obligations of recipients 
thereof; or (4) raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
the Executive Order. DEA has determined that this direct final rule is 
not a ``significant regulatory action'' under Executive Order 12866, 
section 3(f).
    This direct final rule is not an Executive Order 13771 regulatory 
action pursuant to Executive Order 12866 and the Office of Management 
and Budget (OMB) guidance.\1\
---------------------------------------------------------------------------

    \1\ Office of Mgmt. & Budget, Exec. Office of The President, 
Interim Guidance Implementing Section 2 of the Executive Order of 
January 30, 2017 Titled ``Reducing Regulation and Controlling 
Regulatory Costs'' (Feb. 2, 2017).
---------------------------------------------------------------------------

Executive Order 12988, Civil Justice Reform

    The Acting Administrator further certifies that this rulemaking 
meets the applicable standards set forth in sections 3(a) and 3(b)(2) 
of Executive Order 12988 to eliminate drafting errors and ambiguity, 
minimize litigation, provide a clear legal standard for affected 
conduct, and promote simplification and burden reduction.

Executive Order 13132, Federalism

    This rulemaking does not have federalism implications warranting 
the application of Executive Order 13132. The rule does not have 
substantial direct effects on the States, on the relationship between 
the National Government and the States, or the distribution of power 
and responsibilities among the various levels of government.

Executive Order 13175, Consultation and Coordination With Indian Tribal 
Governments

    This rule does not have tribal implications warranting the 
application of Executive Order 13175. It does not have substantial 
direct effects on one or more Indian tribes, on the relationship 
between the Federal Government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
Government and Indian tribes.

Regulatory Flexibility Act

    The Acting 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.

Unfunded Mandates Reform Act of 1995

    In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 
2 U.S.C. 1501 et seq., DEA has determined that this action will not 
result in any Federal mandate that may result in the expenditure by 
State, local and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted for inflation) in any 
one year. Therefore, neither a Small Government Agency Plan nor any 
other action is required under UMRA of 1995.

Paperwork Reduction Act of 1995

    This action does not impose a new collection of information 
requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-
3521. This action does not impose recordkeeping or reporting 
requirements on State or local governments, individuals, businesses, or 
organizations. An agency may not conduct or sponsor, and a person is 
not required to respond to, a collection of information unless it 
displays a currently valid OMB control number.

Congressional Review Act

    This rule is not a major rule as defined by the Congressional 
Review Act (CRA), 5 U.S.C. 804. This rule does not result in: An annual 
effect on the economy of $100,000,000 or more; a major increase in 
costs or prices for consumers, individual industries, Federal, State, 
or local government agencies, or geographic regions; or significant 
adverse effects on competition, employment, investment, productivity, 
innovation, or on the ability of U.S.-based companies to compete with 
foreign based companies in domestic and export markets. However, 
pursuant to the CRA, the DEA has submitted a copy of this direct final 
rule to both Houses of Congress and to the Comptroller General.

List of Subjects in 21 CFR Part 1310

    Drug traffic control, Exports, Imports, Reporting and recordkeeping 
requirements.

    Under the authority vested in the Attorney General by section 
102(39)(A)(vi) of the Act (21 U.S.C. 802(39)(A)(vi)) and delegated to 
the Administrator of the Drug Enforcement Administration by regulations 
of the Department of Justice (28 CFR 0.100), the Acting Administrator 
hereby amends 21 CFR part 1310 as set forth below.

PART 1310--RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN 
MACHINES; IMPORTATION AND EXPORTATION OF 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 amended by:
0
a. Designating the table as table 1 to paragraph (i); and
0
b. Adding the entries ``GFS Chemicals; WaterMark[supreg] Karl-Fisher 
Reagent, Pyridine-Free Single Solution, 5 mg/ml,'' ``GFS Chemicals; 
WaterMark[supreg] Karl-Fisher Reagent, 5 mg/ml Single Solution NON-
HAZ,'' ``GFS Chemicals; WaterMark[supreg] Karl-Fisher Reagent, 
Pyridine-Free Single Solution, 2 mg/ml,'' ``GFS Chemicals; 
WaterMark[supreg] Karl-Fisher Reagent, 2 mg/ml Single Solution NON-
HAZ,'' ``GFS Chemicals; WaterMark[supreg] Karl-Fisher Reagent, 5 mg/ml, 
Stabilized, Pyridine-Based,'' ``Lord Corporation; Chemlok TS701-52,'' 
``Lord Corporation; Chemlok TS701-53,'' ``Sigma-Aldrich; 
Hydranal[supreg]-Composite 1,'' ``Sigma-Aldrich; Hydranal[supreg]-
Composite 2,'' ``Sigma-Aldrich; Hydranal[supreg]-Composite 5K,'' 
``Sigma-Aldrich; Hydranal[supreg]-Composite 5,'' ``Standard Homeopathic 
Co.; Baby Cough Syrup,'' ``Standard Homeopathic Co.; Defend Cough & 
Cold

[[Page 4587]]

Night,'' ``Standard Homeopathic Co.; Defend Cough & Cold,'' and 
``Standard Homeopathic Co.; Diarrex'' in alphabetical order of 
Manufacturer.
    The additions read as follows:


Sec.  1310.13   Exemption of chemical mixtures; application.

* * * * *
    (i) * * *

                               Table 1 to Paragraph (i)--Exempt Chemical Mixtures
----------------------------------------------------------------------------------------------------------------
              Manufacturer                      Product name \1\                   Form            Approval date
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
GFS Chemicals..........................  WaterMark[supreg] Karl-Fisher   Liquid.................      11/26/2018
                                          Reagent, Pyridine-Free Single
                                          Solution, 5 mg/ml.
GFS Chemicals..........................  WaterMark[supreg] Karl-Fisher   Liquid.................      11/26/2018
                                          Reagent, 5 mg/ml Single
                                          Solution NON-HAZ.
GFS Chemicals..........................  WaterMark[supreg] Karl-Fisher   Liquid.................      11/26/2018
                                          Reagent, Pyridine-Free Single
                                          Solution, 2 mg/ml.
GFS Chemicals..........................  WaterMark[supreg] Karl-Fisher   Liquid.................      11/26/2018
                                          Reagent, 2 mg/ml Single
                                          Solution NON-HAZ.
GFS Chemicals..........................  WaterMark[supreg] Karl-Fisher   Liquid.................      11/26/2018
                                          Reagent, 5 mg/ml, Stabilized,
                                          Pyridine-Based.
 
                                                  * * * * * * *
Lord Corporation.......................  Chemlok TS701-52..............  Liquid.................      05/03/2018
Lord Corporation.......................  Chemlok TS701-53..............  Liquid.................      05/03/2018
 
                                                  * * * * * * *
Sigma-Aldrich..........................  Hydranal[supreg]-Composite 1..  Liquid.................       5/29/2013
Sigma-Aldrich..........................  Hydranal[supreg]-Composite 2..  Liquid.................       5/29/2013
Sigma-Aldrich..........................  Hydranal[supreg]-Composite 5K.  Liquid.................       5/29/2013
Sigma-Aldrich..........................  Hydranal[supreg]-Composite 5..  Liquid.................       5/29/2013
Standard Homeopathic Co................  Baby Cough Syrup..............  Liquid.................       9/28/2012
Standard Homeopathic Co................  Defend Cough & Cold Night.....  Liquid.................       9/28/2012
Standard Homeopathic Co................  Defend Cough & Cold...........  Liquid.................       9/28/2012
Standard Homeopathic Co................  Diarrex.......................  Liquid.................       9/28/2012
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ Designate product line if a group.


    Dated: January 3, 2020.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2020-00667 Filed 1-24-20; 8:45 am]
 BILLING CODE 4410-09-P