International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Tapentadol; Tramadol; Ketamine; gamma-Butyrolactone; 22 Additional Substances; Request for Comments, 79465-79469 [2013-31212]

Download as PDF 79465 Federal Register / Vol. 78, No. 250 / Monday, December 30, 2013 / Notices TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued Number of recordkeepers 21 CFR section Number of records per recordkeeper 100 1 101.105(t); recordkeeping pertaining to disclosure requirements for food not accurately labeled for quantity of contents .................................................................... Total .......................................................................... 1 There Average burden per recordkeeping Total annual records 100 Total hours 1 100 676,150 are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of responses per respondent Number of respondents 21 CFR Section/Form No. 101.9(j)(18) and 101.36(h)(2); procedure for small business nutrition labeling exemption notice using Form FDA 3570 ......................................................................... 101.12(h); petitions to establish or amend a RACC ........... 101.69; petitions for nutrient content claims ........................ 101.70; petitions for health claims ....................................... 101.108; written proposal for requesting temporary exemptions from certain regulations for the purpose of conducting food labeling experiments ................................... Average burden per response Total annual responses Total hours 10,000 5 3 5 1 1 1 1 10,000 5 3 5 8 80 25 80 80,000 400 75 400 1 1 1 40 40 Total .............................................................................. maindgalligan on DSK5TPTVN1PROD with NOTICES 1 There 80,915 are no capital costs or operating and maintenance costs associated with this collection of information. The estimated annual third-party disclosure, recordkeeping, and reporting burdens are based on our communications with industry and our knowledge of and experience with food labeling and the submission of petitions and requests to us. As noted, we are revising this collection to include previously approved third-party disclosure burdens associated with the requirement to declare the amount of trans fatty acids present in a food, including dietary supplements. The third-party disclosure burden hours formerly associated with OMB control number 0910–0515 (collection entitled, ‘‘Food Labeling: Trans Fatty Acids in Nutrition Labeling’’) are represented by the citation to § 101.9 on line 4 of table 1 and the citation to § 101.36 on line 17 of table 1. For this revision, we have not added burden hours to line 4 or line 17 of table 1 because, based on our experience with food labeling, the 4 hours estimated for meeting the labeling requirements of § 101.9 and the 4 hours estimated for meeting the labeling requirements of § 101.36 are appropriate estimates of the total time it takes a respondent to meet our requirements for nutrition labeling in §§ 101.9 and 101.36. We are also revising this collection to include previously approved third-party disclosure burdens associated with the voluntary declaration of the quantitative amount and the percent of Daily Value VerDate Mar<15>2010 17:15 Dec 27, 2013 Jkt 232001 of a dietary ingredient on a ‘‘per day’’ basis in addition to the required ‘‘per serving’’ basis. The third-party disclosure burden hours formerly associated with OMB control number 0910–0395 (collection entitled, ‘‘Food Labeling: Nutrition Labeling of Dietary Supplements on a ‘Per Day’ Basis’’) are represented by the citation to § 101.36 on line 17 of Table 1 and the addition of 300 hours to our previous estimate of 48,000 hours. For this revision, we added 300 burden hours to line 17 of table 1 because voluntary labeling on a ‘‘per day’’ basis is in addition to the required ‘‘per serving’’ basis. We estimate that ‘‘per day’’ information would generally be placed on, at most, 10 percent of the estimated 12,000 disclosures, for a total of 1,200 annual disclosures, and that a respondent will spend 15 minutes (0.25 hours) per disclosure, for a total of 300 hours. Thus, the total estimated burden on line 17 of table 1 is 48,300 hours and average burden per disclosure on line 17 of table 1 has been increased from 4.0 to 4.025 hours, to represent an averaging of the burden hours across all of the estimated 12,000 disclosures. We expect that the burden hours for submissions under § 101.108 will be insignificant. Section 101.108 was originally issued to provide a procedure whereby we could grant exemptions from certain food labeling requirements. Exemption petitions have infrequently been submitted in the recent past; none PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 have been submitted since publication on January 6, 1993, of the final regulations implementing section 403(q) and (r) of the FD&C Act. Thus, in order to maintain OMB approval of § 101.108 to accommodate the possibility that a food producer may propose to conduct a labeling experiment on its own initiative, we estimate that we will receive one or fewer submissions under § 101.108 in the next 3 years. Dated: December 23, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–31215 Filed 12–27–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–1676] International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Tapentadol; Tramadol; Ketamine; gamma-Butyrolactone; 22 Additional Substances; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is requesting SUMMARY: E:\FR\FM\30DEN1.SGM 30DEN1 79466 Federal Register / Vol. 78, No. 250 / Monday, December 30, 2013 / Notices interested persons to submit comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 26 drug substances. These comments will be considered in preparing a response from the United States to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs. WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drugs. This notice requesting comments is required by the Controlled Substances Act (CSA). DATES: Submit written or electronic comments by January 29, 2014. ADDRESSES: Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to http:// www.regulations.gov. maindgalligan on DSK5TPTVN1PROD with NOTICES FOR FURTHER INFORMATION CONTACT: James R. Hunter, Center for Drug Evaluation and Research, Controlled Substance Staff, Food and Drug Administration, Bldg. 51, Rm. 5150, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–3156, email: james.hunter@fda.hhs.gov. SUPPLEMENTARY INFORMATION: The United States is a party to the 1971 Convention on Psychotropic Substances. Article 2 of the Convention on Psychotropic Substances provides that if a party to the convention or WHO has information about a substance, which in its opinion may require international control or change in such control, it shall so notify the Secretary General of the United Nations and provide the Secretary General of the United Nations with information in support of its opinion. Section 201 of the CSA (21 U.S.C. 801 et seq.) (Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970) provides that when WHO notifies the United States under Article 2 of the Convention on Psychotropic Substances that it has information that may justify adding a drug or other substances to one of the schedules of the convention, transferring a drug or substance from one schedule to another, or deleting it from the schedules, the Secretary of State must transmit the notice to the Secretary of Health and Human Services (the Secretary of HHS). The Secretary of HHS must then publish the notice in the Federal Register and provide opportunity for interested persons to submit comments that will be considered by HHS in its preparation of VerDate Mar<15>2010 17:15 Dec 27, 2013 Jkt 232001 the scientific and medical evaluations of the drug or substance. I. WHO Notification Substances Identified for Evaluation During the 36th Expert Committee on Drug Dependence Tapentadol N-benzylpiperazine (BZP) Gamma-Butyrolactone (GBL) 1,4-Butanediol (I,4BD) Synthetic cannabinoids JWH–018 JWH–073 AM–2201 UR–144 APINACA (AKB 48) RCS–4 JWH–250 Synthetic Cathinones Mephedrone 4-methylmethcathinone (4– MMC) 3,4-Methylenedioxypyrovalerone (MDPV) Methylone (bk-MDMA) 4-Methylethcathinone (4–MEC) 4-Fluoromethcathinone (flephedrone; 4–FMC) Miscellaneous 25 B NBOMe 25 C NBOMe 25 I NBOMe Alpha-methyltryptamine (AMT) AH–7921 Methoxetamine (MXE) Methiopropamine (MPA) Lisdexamphetamine Tramadol Ketamine The Secretary of HHS received the following notices from WHO: Ref.: C.L.29.2013 The World Health Organization (WHO) presents its compliments to Member States and Associate Members and has the pleasure of informing that the Thirty-sixth Expert Committee on Drug Dependence (ECDD) will meet in June 2014 to review a number of substances with potential for misuse in order to make recommendations to the DirectorGeneral, on the need for and level of international control of these substances. At its 126th session in January 2010, the Executive Board approved the publication ‘‘Guidance on the WHO review of psychoactive substances for international control’’ (EB126/2010/REC1, Annex 6) which requires the Secretariat to request relevant information from Ministers of Health in Member States to prepare a report for submission to the ECDD. For this purpose, a questionnaire was designed to gather information on the legitimate use, harmful use, status of national control and potential impact of international control for each substance under evaluation. Member States are invited to collaborate, as in the past, in this process by providing pertinent information mentioned in the questionnaire concerning substances under review. It would be appreciated if a person from the Ministry of Health could be designated as the focal point responsible for coordinating and answering the questionnaire. It is requested that the email address of the focal point be shared with the Secretariat * * *. Upon receipt of the email of the designated person, the focal point will receive a unique user name, password and link for accessing the questionnaire and responding to questions. Further instructions on answering the questionnaire will be provided, along with the questionnaire, online. Further clarification on the above items can be obtained from the Secretariat by emailing: ecdd_secretariat@who.int. Replies to the questionnaire must reach the Secretariat by 1 February 2014 in order to facilitate analyses and preparation of the report before the planned meeting. Where there is a Competent National Authority under the International Drug Control Treaties, it is kindly requested that the questionnaire be completed in collaboration with such body. The summary information from the questionnaire will be published online as part of the report at the Web site for the Thirty-sixth ECDD linked to the Department of Essential Medicines and Health Products (EMP): http://www.who.int/ medicines/areas/quality_safety/ECDD/en/ index.html. The World Health Organization takes this opportunity to renew to Member States and Associate Members the assurance of its highest consideration. GENEVA, 11 November 2013 * * * * * ENCL.: (1) PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 * * * * * WHO Questionnaire for the 36th Meeting of Expert Committee on Drug Dependence: Substance Definitions: (Def. 1) Legitimate use is use of a substance for legally valid purposes such as medical scientific and industrial. (Def. 2) Harmful use is defined as a pattern of psychoactive substance use that increases the risk of harmful physical, mental, and social consequences for the user or to others. Harmful use of drugs by an individual has potential for adverse effects on the substance user’s family, the community and society in general. Substance* (Insert name of substance) —Do you have any information on this substance on legitimate use, recreational/ harmful use or control status in your country? * (Yes/No) A. LEGITIMATE MEDICAL OR OTHER SCIENTIFIC USE OF THE SUBSTANCE (Def. 1) —Is the substance currently authorized or in the process of being authorized/registered as a medical product in your country? (Yes/No) If ‘‘yes,’’ since when has it been on the market? (input year) —Please state registered indications for this medicine: —Please mention other, if any, medical use not included in the approved indications (off label use): —Please indicate dosage form(s) and strength(s) available in your country; also E:\FR\FM\30DEN1.SGM 30DEN1 Federal Register / Vol. 78, No. 250 / Monday, December 30, 2013 / Notices indicate special properties such as slow release, etc.: Dosage form Strength Remarks 1. 2. 3. —Please list alphabetically the brand names available in your country (there is no need for dosage forms, strengths, etc.): —Are there any other uses for the substance in health care (such as for diagnostic tests) in your country? (Yes/No) If ‘‘yes,’’ what is the use? —Is the chemical used for medical or scientific research in your country? (Yes/ No) If ‘‘yes,’’ please specify: —Is the substance used for animal care (veterinary use)? (Yes/No) —Is there any other legitimate (Def. 1) use of the substance (e.g. industry uses)? (Yes/No) If ‘‘yes,’’ please state the purpose: —If there is any legitimate (Def. 1) use of the substance, how is the substance sourced? (Manufactured in country/Imported) —What is the estimated approximate amount needed for its legitimate use in your country per year? —Is the substance used for cultural or ceremonial purposes? (Yes/No) If ‘‘yes,’’ specify why it is used: Who uses it (the group using)? How is it used? (route of administration): What is its source? 79467 B. HARMFUL USE OF THE SUBSTANCE (Def. 2) —Is there recreational/harmful use of this substance in your country? (Def. 2) (Yes/ No/Unknown) If ‘‘yes,’’ please specify how the substance is used and the extent of use by answering the following questions: Common route(s) of administration (Oral/ Injection/Inhaling or sniffing) How is it obtained? (Diversion/Trafficking/ Clandestine manufacturing) Common formulation(s) available: (Powder/Tablet/Liquid) —Any other information on recreational/ harmful use: —Quantity of substance used by an average misuse per sitting (average dose used): —Is it used by special population(s)? (Club use/General population) Club use (percent) General population (percent) Emergency room visits resulting from the use of this substance Dependence to this substance Estimated proportion of the population using the substance ...................................................................... —Please provide any information on the extent/magnitude of public health or social harm from the use of the substance (Def. 2) in your country: Overdose deaths reported Addiction programme enrolment from the use of this substance Numbers in 2012 ..................................................................... —Are there reports of withdrawal, tolerance, other adverse effects or medical illnesses caused by this substance in your country? (Yes/No) If ‘‘yes,’’ please provide details: —Any other relevant information on harm to individuals or the society: —Please indicate the sources of information on harm: —If actual data are not available, please provide a short description on harm caused by this substance: C. CONTROL OF THE SUBSTANCE —Is the substance controlled under legislation that is intended to regulate its availability in the country? (Yes/No) Number of seizures Year If ‘‘yes,’’ please select which one: (Controlled substances act/Medicines law/ Poisons acts/Consumer protection acts/ Generic legislation/Analogue legislation/ Temporary ban/Other legislation (name)) —How is this law enforced? Please provide a short description: —Are there challenges to implementation? (Yes/No) If ‘‘yes,’’ please specify (e.g. laboratory capacity, resources to implement and/or enforce, expertise): —Are there illicit activities involving the substance? (Yes/No) Clandestine manufacture? (Yes/No) Kilograms Litres The manufacture (synthesis) of the chemical itself (Yes/No) The processing into the consumer product, i.e. adding it to herbal material, packaging (Yes/No) Trafficking (Yes/No) Diversion (Yes/No) Internet market (Yes/No) Other (please specify): —Please provide any other relevant information on illicit activities: —Data on seizures Number of ampoules Number of tablets/pills Other type (quantity) maindgalligan on DSK5TPTVN1PROD with NOTICES 2011 ..................... 2012 ..................... D. IMPACT OF SCHEDULING —If this substance is placed under international control, does your country have the lab capacity to identify the substance? (Yes/No/Unknown) —If this substance is placed under international control, do you think its availability for medical use will be affected? (Yes/No) VerDate Mar<15>2010 17:15 Dec 27, 2013 Jkt 232001 If ‘‘yes,’’ please explain (consider both human and veterinary needs): How could control impact its medical availability? Please identify specific population groups that may be affected, and describe the implications of increased control. —Any additional information on impact of scheduling: * PO 00000 * * Frm 00078 * Fmt 4703 * Sfmt 4703 II. Background Tapentadol is a central nervous system active analgesic agent that has mu (m) opioid agonist properties and inhibits the reuptake of norepinephrine. Tapentadol is approved for marketing in the United States for the treatment of moderate to severe acute pain. E:\FR\FM\30DEN1.SGM 30DEN1 maindgalligan on DSK5TPTVN1PROD with NOTICES 79468 Federal Register / Vol. 78, No. 250 / Monday, December 30, 2013 / Notices Tapentadol is controlled in Schedule II under the CSA in the United States. Tapentadol was pre-reviewed by the WHO Expert Committee on Drug Dependence at its 35th meeting and recommended for critical review at its 36th meeting. N-benzylpiperazine (BZP) is used as an intermediate in chemical synthesis but has been taken orally as either powder or tablets and by other routes, including smoking or snorting. It has no medical use in the United States. BZP is controlled in Schedule I under the CSA in the United States. BZP is not controlled internationally under the Convention on Psychotropic Substances or the Single Convention on Narcotic Drugs. BZP was pre-reviewed by the WHO Expert Committee on Drug Dependence at its 35th meeting and recommended for critical review at its 36th meeting. Gamma-Butyrolactone (GBL) is used as an industrial solvent. GBL can be converted in the body to the central nervous system depressant drug gammahydroxybutyric acid (GHB). GBL is controlled as a List I chemical in the United States under the CSA. It is not controlled internationally under the Convention on Psychotropic Substances or the Single Convention on Narcotic Drugs. GBL was pre-reviewed by the WHO Expert Committee on Drug Dependence at its 35th meeting and recommended for critical review at its 36th meeting. 1,4-Butanediol is used as an industrial solvent for manufacturing and also used for the synthesis of GBL. 1,4-Butanediol can also be converted to the central nervous depressant drug GHB. It has no medical use in the United States. 1,4Butanediol is not controlled under the CSA in the United States, but it is subject to controls in several states under state law. 1,4-Butanediol was prereviewed by the WHO Expert Committee on Drug Dependence at its 35th meeting and recommended for critical review at its 36th meeting. The following substances are classified as synthetic cannabinoids with pharmacological properties like tetrahydrocannabinol: (1-pentyl-1Hindol-3-yl)-1-naphthalenyl-methanone (JWH–018), (1-butyl-1H-indol-3-yl)-1naphthalenyl-methanone (JWH–073), 1(1-pentyl-1H-indol-3-yl)-2-(2methoxyphenyl)-ethanone (JWH–250), [1-(5-fluoropentyl)-1H-indol-3-yl]-1naphthalenyl-methanone (AM–2201), (1-pentyl-1H-indol-3-yl)(2,2,3,3tetramethylcyclopropyl)-methanone (UR–144), 1-pentyl-Ntricyclo[3.3.1.13,7]dec-l-yl-1H-indazole3-carboxamide (APINACA; AKB48), and (4-methoxyphenyl)(1-pentyl-1H-indol-3- VerDate Mar<15>2010 17:15 Dec 27, 2013 Jkt 232001 yl)methanone (RCS–4). JWH–018, JWH– 073, JWH–250, AM–2201, and RCS–4 are controlled in Schedule I under the CSA in the United States. On May 16, 2013, UR–144 and AKB 48 were temporarily placed in Schedule I under the CSA pursuant to the temporary scheduling provisions of section 201(h) of the CSA (21 U.S.C. 811(h)). 4-Methylmethcathinone (4–MMC; mephedrone), 3,4methylenedioxypyrovalerone (MDPV), 3,4-methylenedioxy-N-methylcathinone (bk-MDMA; Methylone), 4methylethcathinone (4–MEC), and 4fluoromethcathinone (flephedrone; 4– FMC) are classified as synthetic cathinones in the phenethylamine class and are structurally and pharmacologically similar to amphetamine, 3,4methylenedioxymethamphetamine (MDMA), cathinone and other related substances. 4–MMC, MDPV, and Methylone are controlled in Schedule I under the CSA in the United States. 4– MEC and 4–FMC are not controlled under the CSA in the United States. 2-(4-bromo-2,5-dimethoxyphenyl)-N[(2-methoxyphenyl)methyl]ethanamine (25B–NBOMe), 2-(4-chloro-2,5dimethoxyphenyl)-N-(2methoxybenzyl)ethanamine (25C– NBOMe), and 2-(4-iodo-2,5dimethoxyphenyl)-N-[(2methoxyphenyl)methyl]ethanamine (25I–NBOMe) are synthetic 2C phenethylamine substances and were developed for use in mapping and investigating the serotonin receptors in the mammalian brain. On November 15, 2013, 25B–NBOMe, 25C–NBOMe, and 25I–NBOMe were temporarily placed in Schedule I of the CSA pursuant to the temporary scheduling provision of section 201(h) of the CSA. Alpha-Methyltryptamine (AMT) is a tryptamine (indoleethylamine) derivative and shares several similarities with the Schedule I tryptamine hallucinogens, such as alpha-ethyltryptamine (AET) and N,Ndimethyltryptamine (DMT). AMT is controlled in Schedule I under the CSA in the United States. AH–7921, or 1-(3,4dichlorobenzamidomethyl) cyclohexyldimethylamine, is an opioid analgesic drug selective for the m-opioid receptor and is not controlled under the CSA in the United States. Methoxetamine (MXE), or 2(ethylamino)-2-(3-methoxyphenyl)cyclohexanone, is an arylcyclohexamine and is not controlled under the CSA in the United States. MXE can be considered as a controlled substance analogue of eticyclidine (PCE) under the PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 CSA if intended for human consumption. Methiopropamine (MPA) is a thiophene analog of methamphetamine and is not controlled under the CSA in the United States. Lisdexamphetamine is an amide ester conjugate comprised of the amino acid L-lysine covalently bound to the amino group of d-amphetamine. Lisdexamphetamine was approved for marketing in the United States in 2007 and is used for the treatment of Attention Deficit Hyperactivity Disorder. Lisdexamphetamine was placed in Schedule II of the CSA in June 2007. Tramadol is an opioid analgesic that produces its primary opioid-like action through an active metabolite referred to as the M1 metabolite·(Odesmethyltramadol). Tramadol was first approved for marketing in the United States in 1995 and is available in immediate-release, extended-release, and combination product for the treatment of moderate to moderatelysevere pain. In November 2013, Tramadol was proposed to be placed in Schedule IV of the CSA. The Secretariat indicates that additional safety information on this substance is available, thus an updated review for Tramadol is necessary for presentation at the 36th meeting of the WHO Expert Committee on Drug Dependence. Ketamine is classified as a rapidacting general anesthetic agent used for short diagnostic and surgical procedures that do not require skeletal muscle relaxation. It is marketed in the United States as an injectable. Ketamine is controlled in Schedule III of the CSA in the United States. It is not controlled internationally under the Convention on Psychotropic Substances or the Single Convention on Narcotic Drugs. The WHO Expert Committee on Drug Dependence reviewed ketamine at its 34th and 35th meetings. The Secretariat indicates that additional safety information on this substance is available, thus an updated review for ketamine is necessary for presentation at the 36th meeting of the WHO Expert Committee on Drug Dependence. III. Opportunity To Submit Domestic Information As required by section 201(d)(2)(A) of the CSA, FDA, on behalf of the Department of Health and Human Services (HHS), invites interested persons to submit comments regarding the 26 named drugs. Any comments received will be considered by HHS when it prepares a scientific and medical evaluation of these drugs. HHS will forward a scientific and medical E:\FR\FM\30DEN1.SGM 30DEN1 Federal Register / Vol. 78, No. 250 / Monday, December 30, 2013 / Notices evaluation of these drugs to WHO, through the Secretary of State, for WHO’s consideration in deciding whether to recommend international control/decontrol of any of these drugs. Such control could limit, among other things, the manufacture and distribution (import/export) of these drugs and could impose certain recordkeeping requirements on them. HHS will not now make any recommendations to WHO regarding whether any of these drugs should be subjected to international controls. Instead, HHS will defer such consideration until WHO has made official recommendations to the Commission on Narcotic Drugs, which are expected to be made in early 2015. Any HHS position regarding international control of these drugs will be preceded by another Federal Register notice soliciting public comments, as required by section 201(d)(2)(B) of the CSA. IV. Comments Interested persons may submit either electronic comments regarding the drugs to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES) by January 29, 2014. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this notice. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http:// www.regulations.gov. Dated: December 24, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–31212 Filed 12–27–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Strategies To Address Hemolytic Complications of Immune Globulin Infusions; Public Workshop maindgalligan on DSK5TPTVN1PROD with NOTICES AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA) is announcing a public workshop entitled ‘‘Strategies to Address Hemolytic Complications of Immune Globulin Infusions.’’ The purpose of the public workshop is to identify and VerDate Mar<15>2010 17:15 Dec 27, 2013 Jkt 232001 discuss potential risk mitigation strategies for Immune Globulin (Ig)associated hemolysis and to identify and discuss important research questions related to patient risk and product characteristics. The workshop has been planned in partnership with the National Heart, Lung, and Blood Institute, National Institutes of Health, and the Plasma Protein Therapeutics Association. The workshop will include presentations and panel discussions by experts from academic institutions, industry, and government agencies. Dates and Times: The public workshop will be held on January 28, 2014, 8:30 a.m. to 5 p.m. and January 29, 2014, 8:30 a.m. to 12 noon. Location: The public workshop will be held at Lister Hill Center Auditorium, National Institutes of Health Campus, Building 38A, 8600 Rockville Pike, Bethesda, MD 20894. Contact Person: Chris Nguyen, Center for Biologics Evaluation and Research (HFM–49), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–2000, FAX: 301–827–3079, email: CBERPublicEvents@fda.hhs.gov. Registration: Mail or fax your registration information (including name, title, firm name, address, telephone, and fax numbers) to Chris Nguyen (see Contact Person) or email to CBERPublicEvents@fda.hhs.gov (subject line: IG Hemolysis Workshop Registration) by January 10, 2014. There is no registration fee for the public workshop. Early registration is recommended because seating is limited. Registration on the day of the public workshop will be provided on a space available basis beginning at 7:30 a.m. Pre-registered participants will receive additional information on security procedures, parking, and public transportation with their email registration confirmation. If you need special accommodations due to a disability, please contact Chris Nguyen (see Contact Person) at least 7 days in advance. SUPPLEMENTARY INFORMATION: Clinically significant hemolysis is a longrecognized complication of Immune Globulin Intravenous (IGIV) (Human) infusion. Complications of hemolysis include severe anemia requiring transfusion, renal failure, and disseminated intravascular coagulation. Ig-associated hemolysis has been generally thought to be caused by the presence of Immunoglobulin G (IgG) antibodies against major red blood cell antigens. All FDA-licensed Ig products are tested and have upper limit release specifications for antibodies against PO 00000 Frm 00080 Fmt 4703 Sfmt 9990 79469 blood group antigens A, B, and Rho(D). However, IGIV-associated hemolysis occurs despite adherence to these specifications. In addition, there are factors that may increase a patient’s risk for hemolysis. Known patient risk factors for hemolysis include: (1) High doses of IGIV; (2) recipient blood type A, AB, or B; and (3) other factors, such as history of hemolysis and possibly underlying inflammatory disease. The goals of the workshop are to identify and discuss potential risk mitigation strategies for Ig-associated hemolysis, including improved identification of patients at high risk for hemolysis; changes in product specifications, tests, or test methods; and modifications to manufacturing to lower product risk. In addition, this workshop is intended to identify and discuss important outstanding research questions related to patient risk and product characteristics. The first day of this workshop will include presentations and panel discussions on the following topics: (1) Pathogenesis and epidemiology of IGIVassociated hemolysis; (2) patient risk factors; and (3) possible product risk factors, including the presence of AntiA and Anti-B hemagglutinins. The second day of the workshop will include presentations and panel discussions on the following topics: (1) Immune globulin manufacturing and risk mitigation strategies and (2) workshop summary and conclusions. Transcripts: Please be advised that as soon as possible after a transcript of the public workshop is available, it will be accessible at: http://www.fda.gov/ BiologicsBloodVaccines/NewsEvents/ WorkshopsMeetingsConferences/ TranscriptsMinutes/default.htm. Transcripts of the public workshop may also be requested in writing from the Division of Freedom of Information (ELEM–1029), Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857. Dated: December 23, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–31213 Filed 12–27–13; 8:45 am] BILLING CODE 4160–01–P E:\FR\FM\30DEN1.SGM 30DEN1

Agencies

[Federal Register Volume 78, Number 250 (Monday, December 30, 2013)]
[Notices]
[Pages 79465-79469]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-31212]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1676]


International Drug Scheduling; Convention on Psychotropic 
Substances; Single Convention on Narcotic Drugs; Tapentadol; Tramadol; 
Ketamine; gamma-Butyrolactone; 22 Additional Substances; Request for 
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is requesting

[[Page 79466]]

interested persons to submit comments concerning abuse potential, 
actual abuse, medical usefulness, trafficking, and impact of scheduling 
changes on availability for medical use of 26 drug substances. These 
comments will be considered in preparing a response from the United 
States to the World Health Organization (WHO) regarding the abuse 
liability and diversion of these drugs. WHO will use this information 
to consider whether to recommend that certain international 
restrictions be placed on these drugs. This notice requesting comments 
is required by the Controlled Substances Act (CSA).

DATES: Submit written or electronic comments by January 29, 2014.

ADDRESSES: Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: James R. Hunter, Center for Drug 
Evaluation and Research, Controlled Substance Staff, Food and Drug 
Administration, Bldg. 51, Rm. 5150, 10903 New Hampshire Ave., Silver 
Spring, MD 20993-0002, 301-796-3156, email: james.hunter@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: The United States is a party to the 1971 
Convention on Psychotropic Substances. Article 2 of the Convention on 
Psychotropic Substances provides that if a party to the convention or 
WHO has information about a substance, which in its opinion may require 
international control or change in such control, it shall so notify the 
Secretary General of the United Nations and provide the Secretary 
General of the United Nations with information in support of its 
opinion.
    Section 201 of the CSA (21 U.S.C. 801 et seq.) (Title II of the 
Comprehensive Drug Abuse Prevention and Control Act of 1970) provides 
that when WHO notifies the United States under Article 2 of the 
Convention on Psychotropic Substances that it has information that may 
justify adding a drug or other substances to one of the schedules of 
the convention, transferring a drug or substance from one schedule to 
another, or deleting it from the schedules, the Secretary of State must 
transmit the notice to the Secretary of Health and Human Services (the 
Secretary of HHS). The Secretary of HHS must then publish the notice in 
the Federal Register and provide opportunity for interested persons to 
submit comments that will be considered by HHS in its preparation of 
the scientific and medical evaluations of the drug or substance.

I. WHO Notification

    The Secretary of HHS received the following notices from WHO:

Ref.: C.L.29.2013

    The World Health Organization (WHO) presents its compliments to 
Member States and Associate Members and has the pleasure of 
informing that the Thirty-sixth Expert Committee on Drug Dependence 
(ECDD) will meet in June 2014 to review a number of substances with 
potential for misuse in order to make recommendations to the 
Director-General, on the need for and level of international control 
of these substances.
    At its 126th session in January 2010, the Executive Board 
approved the publication ``Guidance on the WHO review of 
psychoactive substances for international control'' (EB126/2010/
REC1, Annex 6) which requires the Secretariat to request relevant 
information from Ministers of Health in Member States to prepare a 
report for submission to the ECDD. For this purpose, a questionnaire 
was designed to gather information on the legitimate use, harmful 
use, status of national control and potential impact of 
international control for each substance under evaluation. Member 
States are invited to collaborate, as in the past, in this process 
by providing pertinent information mentioned in the questionnaire 
concerning substances under review.
    It would be appreciated if a person from the Ministry of Health 
could be designated as the focal point responsible for coordinating 
and answering the questionnaire. It is requested that the email 
address of the focal point be shared with the Secretariat * * *. 
Upon receipt of the email of the designated person, the focal point 
will receive a unique user name, password and link for accessing the 
questionnaire and responding to questions. Further instructions on 
answering the questionnaire will be provided, along with the 
questionnaire, online. Further clarification on the above items can 
be obtained from the Secretariat by emailing: ecdd_secretariat@who.int. Replies to the questionnaire must reach the 
Secretariat by 1 February 2014 in order to facilitate analyses and 
preparation of the report before the planned meeting. Where there is 
a Competent National Authority under the International Drug Control 
Treaties, it is kindly requested that the questionnaire be completed 
in collaboration with such body. The summary information from the 
questionnaire will be published online as part of the report at the 
Web site for the Thirty-sixth ECDD linked to the Department of 
Essential Medicines and Health Products (EMP): http://www.who.int/medicines/areas/quality_safety/ECDD/en/index.html.
    The World Health Organization takes this opportunity to renew to 
Member States and Associate Members the assurance of its highest 
consideration.

    GENEVA, 11 November 2013
* * * * *
ENCL.: (1)

Substances Identified for Evaluation During the 36th Expert Committee 
on Drug Dependence

Tapentadol
N-benzylpiperazine (BZP)
Gamma-Butyrolactone (GBL)
1,4-Butanediol (I,4BD)
Synthetic cannabinoids
    JWH-018
    JWH-073
    AM-2201
    UR-144
    APINACA (AKB 48)
    RCS-4
    JWH-250

Synthetic Cathinones
    Mephedrone 4-methylmethcathinone (4-MMC)
    3,4-Methylenedioxypyrovalerone (MDPV)
    Methylone (bk-MDMA)
    4-Methylethcathinone (4-MEC)
    4-Fluoromethcathinone (flephedrone; 4-FMC)
Miscellaneous
    25 B NBOMe
    25 C NBOMe
    25 I NBOMe
    Alpha-methyltryptamine (AMT)
    AH-7921
    Methoxetamine (MXE)
    Methiopropamine (MPA)
Lisdexamphetamine
Tramadol
Ketamine

* * * * *

WHO Questionnaire for the 36th Meeting of Expert Committee on Drug 
Dependence: Substance

Definitions:

    (Def. 1) Legitimate use is use of a substance for legally valid 
purposes such as medical scientific and industrial.
    (Def. 2) Harmful use is defined as a pattern of psychoactive 
substance use that increases the risk of harmful physical, mental, 
and social consequences for the user or to others. Harmful use of 
drugs by an individual has potential for adverse effects on the 
substance user's family, the community and society in general.

Substance* (Insert name of substance)

--Do you have any information on this substance on legitimate use, 
recreational/harmful use or control status in your country? \*\ 
(Yes/No)

A. LEGITIMATE MEDICAL OR OTHER SCIENTIFIC USE OF THE SUBSTANCE (Def. 1)

--Is the substance currently authorized or in the process of being 
authorized/registered as a medical product in your country? (Yes/No)

    If ``yes,'' since when has it been on the market? (input year)

--Please state registered indications for this medicine:
--Please mention other, if any, medical use not included in the 
approved indications (off label use):
--Please indicate dosage form(s) and strength(s) available in your 
country; also

[[Page 79467]]

indicate special properties such as slow release, etc.:

------------------------------------------------------------------------
                      Dosage form         Strength           Remarks
------------------------------------------------------------------------
1.                 .................  ................  ................
2.                 .................  ................  ................
3.                 .................  ................  ................
------------------------------------------------------------------------

--Please list alphabetically the brand names available in your 
country (there is no need for dosage forms, strengths, etc.):
--Are there any other uses for the substance in health care (such as 
for diagnostic tests) in your country? (Yes/No)
    If ``yes,'' what is the use?
--Is the chemical used for medical or scientific research in your 
country? (Yes/No)
    If ``yes,'' please specify:
--Is the substance used for animal care (veterinary use)? (Yes/No)
--Is there any other legitimate (Def. 1) use of the substance (e.g. 
industry uses)? (Yes/No)
    If ``yes,'' please state the purpose:
--If there is any legitimate (Def. 1) use of the substance, how is 
the substance sourced? (Manufactured in country/Imported)
--What is the estimated approximate amount needed for its legitimate 
use in your country per year?
--Is the substance used for cultural or ceremonial purposes? (Yes/
No)
    If ``yes,'' specify why it is used:
    Who uses it (the group using)?
    How is it used? (route of administration):
    What is its source?

B. HARMFUL USE OF THE SUBSTANCE (Def. 2)

--Is there recreational/harmful use of this substance in your 
country? (Def. 2) (Yes/No/Unknown)
    If ``yes,'' please specify how the substance is used and the 
extent of use by answering the following questions:
    Common route(s) of administration (Oral/Injection/Inhaling or 
sniffing)
    How is it obtained? (Diversion/Trafficking/Clandestine 
manufacturing)
    Common formulation(s) available: (Powder/Tablet/Liquid)

--Any other information on recreational/harmful use:
--Quantity of substance used by an average misuse per sitting 
(average dose used):
--Is it used by special population(s)? (Club use/General population)

------------------------------------------------------------------------
                                                            General
                                         Club use          population
                                        (percent)          (percent)
------------------------------------------------------------------------
Estimated proportion of the
 population using the substance...
------------------------------------------------------------------------

--Please provide any information on the extent/magnitude of public 
health or social harm from the use of the substance (Def. 2) in your 
country:

----------------------------------------------------------------------------------------------------------------
                                                             Addiction
                                                             programme        Emergency room
                                       Overdose deaths     enrolment from    visits resulting    Dependence to
                                           reported       the use of this    from the use of     this substance
                                                             substance        this substance
----------------------------------------------------------------------------------------------------------------
Numbers in 2012.....................
----------------------------------------------------------------------------------------------------------------

--Are there reports of withdrawal, tolerance, other adverse effects 
or medical illnesses caused by this substance in your country? (Yes/
No)
    If ``yes,'' please provide details:
--Any other relevant information on harm to individuals or the 
society:
--Please indicate the sources of information on harm:
--If actual data are not available, please provide a short 
description on harm caused by this substance:

C. CONTROL OF THE SUBSTANCE

--Is the substance controlled under legislation that is intended to 
regulate its availability in the country? (Yes/No)

    If ``yes,'' please select which one: (Controlled substances act/
Medicines law/Poisons acts/Consumer protection acts/Generic 
legislation/Analogue legislation/Temporary ban/Other legislation 
(name))

--How is this law enforced? Please provide a short description:
--Are there challenges to implementation? (Yes/No)

    If ``yes,'' please specify (e.g. laboratory capacity, resources 
to implement and/or enforce, expertise):

--Are there illicit activities involving the substance? (Yes/No)
    Clandestine manufacture? (Yes/No)
    The manufacture (synthesis) of the chemical itself (Yes/No)
    The processing into the consumer product, i.e. adding it to 
herbal material, packaging (Yes/No)
    Trafficking (Yes/No)
    Diversion (Yes/No)
    Internet market (Yes/No)
    Other (please specify):
--Please provide any other relevant information on illicit 
activities:
--Data on seizures

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                            Number of                                                Number of      Number of tablets/     Other type
                 Year                        seizures          Kilograms            Litres            ampoules            pills            (quantity)
--------------------------------------------------------------------------------------------------------------------------------------------------------
2011..................................
2012..................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

D. IMPACT OF SCHEDULING

--If this substance is placed under international control, does your 
country have the lab capacity to identify the substance? (Yes/No/
Unknown)
--If this substance is placed under international control, do you 
think its availability for medical use will be affected? (Yes/No)

    If ``yes,'' please explain (consider both human and veterinary 
needs): How could control impact its medical availability? Please 
identify specific population groups that may be affected, and 
describe the implications of increased control.

--Any additional information on impact of scheduling:
* * * * *

II. Background

    Tapentadol is a central nervous system active analgesic agent that 
has mu ([micro]) opioid agonist properties and inhibits the reuptake of 
norepinephrine. Tapentadol is approved for marketing in the United 
States for the treatment of moderate to severe acute pain.

[[Page 79468]]

Tapentadol is controlled in Schedule II under the CSA in the United 
States. Tapentadol was pre-reviewed by the WHO Expert Committee on Drug 
Dependence at its 35th meeting and recommended for critical review at 
its 36th meeting.
    N-benzylpiperazine (BZP) is used as an intermediate in chemical 
synthesis but has been taken orally as either powder or tablets and by 
other routes, including smoking or snorting. It has no medical use in 
the United States. BZP is controlled in Schedule I under the CSA in the 
United States. BZP is not controlled internationally under the 
Convention on Psychotropic Substances or the Single Convention on 
Narcotic Drugs. BZP was pre-reviewed by the WHO Expert Committee on 
Drug Dependence at its 35th meeting and recommended for critical review 
at its 36th meeting.
    Gamma-Butyrolactone (GBL) is used as an industrial solvent. GBL can 
be converted in the body to the central nervous system depressant drug 
gamma-hydroxybutyric acid (GHB). GBL is controlled as a List I chemical 
in the United States under the CSA. It is not controlled 
internationally under the Convention on Psychotropic Substances or the 
Single Convention on Narcotic Drugs. GBL was pre-reviewed by the WHO 
Expert Committee on Drug Dependence at its 35th meeting and recommended 
for critical review at its 36th meeting.
    1,4-Butanediol is used as an industrial solvent for manufacturing 
and also used for the synthesis of GBL. 1,4-Butanediol can also be 
converted to the central nervous depressant drug GHB. It has no medical 
use in the United States. 1,4-Butanediol is not controlled under the 
CSA in the United States, but it is subject to controls in several 
states under state law. 1,4-Butanediol was pre-reviewed by the WHO 
Expert Committee on Drug Dependence at its 35th meeting and recommended 
for critical review at its 36th meeting.
    The following substances are classified as synthetic cannabinoids 
with pharmacological properties like tetrahydrocannabinol: (1-pentyl-
1H-indol-3-yl)-1-naphthalenyl-methanone (JWH-018), (1-butyl-1H-indol-3-
yl)-1-naphthalenyl-methanone (JWH-073), 1-(1-pentyl-1H-indol-3-yl)-2-
(2-methoxyphenyl)-ethanone (JWH-250), [1-(5-fluoropentyl)-1H-indol-3-
yl]-1-naphthalenyl-methanone (AM-2201), (1-pentyl-1H-indol-3-
yl)(2,2,3,3-tetramethylcyclopropyl)-methanone (UR-144), 1-pentyl-N-
tricyclo[3.3.1.13,7]dec-l-yl-1H-indazole-3-carboxamide (APINACA; 
AKB48), and (4-methoxyphenyl)(1-pentyl-1H-indol-3-yl)methanone (RCS-4). 
JWH-018, JWH-073, JWH-250, AM-2201, and RCS-4 are controlled in 
Schedule I under the CSA in the United States. On May 16, 2013, UR-144 
and AKB 48 were temporarily placed in Schedule I under the CSA pursuant 
to the temporary scheduling provisions of section 201(h) of the CSA (21 
U.S.C. 811(h)).
    4-Methylmethcathinone (4-MMC; mephedrone), 3,4-
methylenedioxypyrovalerone (MDPV), 3,4-methylenedioxy-N-methylcathinone 
(bk-MDMA; Methylone), 4-methylethcathinone (4-MEC), and 4-
fluoromethcathinone (flephedrone; 4-FMC) are classified as synthetic 
cathinones in the phenethylamine class and are structurally and 
pharmacologically similar to amphetamine, 3,4-
methylenedioxymethamphetamine (MDMA), cathinone and other related 
substances. 4-MMC, MDPV, and Methylone are controlled in Schedule I 
under the CSA in the United States. 4-MEC and 4-FMC are not controlled 
under the CSA in the United States.
    2-(4-bromo-2,5-dimethoxyphenyl)-N-[(2-
methoxyphenyl)methyl]ethanamine (25B-NBOMe), 2-(4-chloro-2,5-
dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-NBOMe), and 2-(4-
iodo-2,5-dimethoxyphenyl)-N-[(2-methoxyphenyl)methyl]ethanamine (25I-
NBOMe) are synthetic 2C phenethylamine substances and were developed 
for use in mapping and investigating the serotonin receptors in the 
mammalian brain. On November 15, 2013, 25B-NBOMe, 25C-NBOMe, and 25I-
NBOMe were temporarily placed in Schedule I of the CSA pursuant to the 
temporary scheduling provision of section 201(h) of the CSA.
    Alpha-Methyltryptamine (AMT) is a tryptamine (indoleethylamine) 
derivative and shares several similarities with the Schedule I 
tryptamine hallucinogens, such as alpha-ethyltryptamine (AET) and N,N-
dimethyltryptamine (DMT). AMT is controlled in Schedule I under the CSA 
in the United States.
    AH-7921, or 1-(3,4-dichlorobenzamidomethyl)cyclohexyldimethylamine, 
is an opioid analgesic drug selective for the [micro]-opioid receptor 
and is not controlled under the CSA in the United States.
    Methoxetamine (MXE), or 2-(ethylamino)-2-(3-methoxyphenyl)-
cyclohexanone, is an arylcyclohexamine and is not controlled under the 
CSA in the United States. MXE can be considered as a controlled 
substance analogue of eticyclidine (PCE) under the CSA if intended for 
human consumption.
    Methiopropamine (MPA) is a thiophene analog of methamphetamine and 
is not controlled under the CSA in the United States.
    Lisdexamphetamine is an amide ester conjugate comprised of the 
amino acid L-lysine covalently bound to the amino group of d-
amphetamine. Lisdexamphetamine was approved for marketing in the United 
States in 2007 and is used for the treatment of Attention Deficit 
Hyperactivity Disorder. Lisdexamphetamine was placed in Schedule II of 
the CSA in June 2007.
    Tramadol is an opioid analgesic that produces its primary opioid-
like action through an active metabolite referred to as the M1 
metabolite[middot](O-desmethyltramadol). Tramadol was first approved 
for marketing in the United States in 1995 and is available in 
immediate-release, extended-release, and combination product for the 
treatment of moderate to moderately-severe pain. In November 2013, 
Tramadol was proposed to be placed in Schedule IV of the CSA. The 
Secretariat indicates that additional safety information on this 
substance is available, thus an updated review for Tramadol is 
necessary for presentation at the 36th meeting of the WHO Expert 
Committee on Drug Dependence.
    Ketamine is classified as a rapid-acting general anesthetic agent 
used for short diagnostic and surgical procedures that do not require 
skeletal muscle relaxation. It is marketed in the United States as an 
injectable. Ketamine is controlled in Schedule III of the CSA in the 
United States. It is not controlled internationally under the 
Convention on Psychotropic Substances or the Single Convention on 
Narcotic Drugs. The WHO Expert Committee on Drug Dependence reviewed 
ketamine at its 34th and 35th meetings. The Secretariat indicates that 
additional safety information on this substance is available, thus an 
updated review for ketamine is necessary for presentation at the 36th 
meeting of the WHO Expert Committee on Drug Dependence.

III. Opportunity To Submit Domestic Information

    As required by section 201(d)(2)(A) of the CSA, FDA, on behalf of 
the Department of Health and Human Services (HHS), invites interested 
persons to submit comments regarding the 26 named drugs. Any comments 
received will be considered by HHS when it prepares a scientific and 
medical evaluation of these drugs. HHS will forward a scientific and 
medical

[[Page 79469]]

evaluation of these drugs to WHO, through the Secretary of State, for 
WHO's consideration in deciding whether to recommend international 
control/decontrol of any of these drugs. Such control could limit, 
among other things, the manufacture and distribution (import/export) of 
these drugs and could impose certain recordkeeping requirements on 
them.
    HHS will not now make any recommendations to WHO regarding whether 
any of these drugs should be subjected to international controls. 
Instead, HHS will defer such consideration until WHO has made official 
recommendations to the Commission on Narcotic Drugs, which are expected 
to be made in early 2015. Any HHS position regarding international 
control of these drugs will be preceded by another Federal Register 
notice soliciting public comments, as required by section 201(d)(2)(B) 
of the CSA.

IV. Comments

    Interested persons may submit either electronic comments regarding 
the drugs to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES) by January 29, 2014. It 
is only necessary to send one set of comments. Identify comments with 
the docket number found in brackets in the heading of this notice. 
Received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to 
the docket at http://www.regulations.gov.

    Dated: December 24, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-31212 Filed 12-27-13; 8:45 am]
BILLING CODE 4160-01-P