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■ 10. Amend § 143.23 by revising § 145.31 [Amended] for a hearing or to participate in a paragraph (j) and adding paragraph (k) ■ 13. Amend § 145.31 by removing the hearing must be received on or before to read as follows: figure ‘‘$200’’ and adding in its place September 26, 2016. ADDRESSES: § 143.23 Form of entry. ‘‘$800’’ in the section heading and text. To ensure proper handling of comments, please reference ‘‘Docket * * * * * R. Gil Kerlikowske, No. DEA–375’’ on all correspondence, (j) Except for mail importations (see Commissioner, U.S. Customs and Border including any attachments. §§ 145.31 and 145.32 of this chapter), or Protection. • Electronic comments: The Drug in the case of personal written or oral Approved: August 23, 2016. Enforcement Administration encourages declarations (see §§ 148.12, 148.13, and Timothy E. Skud, that all comments be submitted 148.62 of this chapter), a shipment of Assistant Secretary of the Treasury. electronically through the Federal merchandise that qualifies for informal [FR Doc. 2016–20581 Filed 8–25–16; 8:45 am] eRulemaking Portal, which provides the entry under 19 U.S.C. 1498 may be BILLING CODE 9111–14–P ability to type short comments directly entered, including the information into the comment field on the Web page listed in paragraph (k) of this section, by or attach a file for lengthier comments. presenting the bill of lading or a DEPARTMENT OF JUSTICE Please go to http://www.regulations.gov manifest listing each bill of lading and follow the online instructions at when: Drug Enforcement Administration that site for submitting comments. Upon (1) The value of the shipment does completion of your submission, you will not exceed $100 in the case of a bona 21 CFR Parts 1301, 1305, and 1308 receive a Comment Tracking Number for your comment. Please be aware that fide gift from a person in a foreign [Docket No. DEA–375] country to a person in the United States submitted comments are not and the shipment meets the Schedules of Controlled Substances: instantaneously available for public requirements in § 10.152 of this chapter Placement of Thiafentanil Into view on Regulations.gov. If you have (see § 10.152 of this chapter); Schedule II received a Comment Tracking Number, your comment has been successfully (2) The value of the shipment does AGENCY: Drug Enforcement submitted and there is no need to not exceed $200 in the case of articles Administration, Department of Justice. resubmit the same comment. (including bona fide gifts) from the • ACTION: Interim final rule with request Paper comments: Paper comments Virgin Islands, Guam, and American for comments. that duplicate the electronic submission Samoa and the shipment meets the are not necessary and are discouraged. requirements in § 10.152 of this chapter SUMMARY: The Drug Enforcement Should you wish to mail a paper (see § 10.152 of this chapter); or Administration is placing the substance comment in lieu of an electronic (3) The value of the shipment does thiafentanil (4-(methoxycarbonyl)-4-(N- comment, it should be sent via regular not exceed $800 and the shipment phenmethoxyacetamido)-1-[2- or express mail to: Drug Enforcement satisfies the requirements in § 10.151 of (thienyl)ethyl]piperidine), including its Administration, Attn: DEA Federal this chapter (see §§ 10.151 and 128.24(e) isomers, esters, ethers, salts and salts of Register Representative/ODW, 8701 of this chapter). isomers, esters and ethers as possible, Morrissette Drive, Springfield, Virginia into schedule II of the Controlled 22152. (k) The following information is • required to be filed as a part of entry Substances Act. This scheduling action Hearing requests: All requests for made under paragraph (j) of this section: is pursuant to the Controlled Substances hearing and waivers of participation Act, as revised by the Improving must be sent to: Drug Enforcement (1) Country of origin of the Regulatory Transparency for New Administration, Attn: Administrator, merchandise; Medical Therapies Act which was 8701 Morrissette Drive, Springfield, (2) Shipper name, address and signed into law on November 25, 2015. Virginia 22152. All requests for hearing country; DATES: The effective date of this rule is and waivers of participation should also (3) Ultimate consignee name and August 26, 2016. Interested persons may be sent to: (1) Drug Enforcement address; file written comments on this rule in Administration, Attn: Hearing Clerk/LJ, accordance with 21 U.S.C. 811(j)(3) and 8701 Morrissette Drive, Springfield, (4) Specific description of the Virginia 22152; and (2) Drug merchandise; 21 CFR 1308.43(g). Electronic comments must be submitted, and written Enforcement Administration, Attn: DEA (5) Quantity; comments must be postmarked, on or Federal Register Representative/ODW, (6) Shipping weight; and before September 26, 2016. Commenters 8701 Morrissette Drive, Springfield, Virginia 22152. (7) Value. should be aware that the electronic Federal Docket Management System FOR FURTHER INFORMATION CONTACT: ■ 11. Amend § 143.26 by removing the will not accept comments after 11:59 Michael J. Lewis, Office of Diversion figure ‘‘$200’’ and adding in its place p.m. Eastern Time on the last day of the Control, Drug Enforcement ‘‘$800’’ in two places each in paragraphs comment period. Administration; Mailing Address: 8701 (a) and (b). Interested persons, defined at 21 CFR Morrissette Drive, Springfield, Virginia 1300.01 as those ‘‘adversely affected or 22152; Telephone: (202) 598–6812. PART 145—MAIL IMPORTATIONS aggrieved by any rule or proposed rule SUPPLEMENTARY INFORMATION: issuable pursuant to section 201 of the ■ 12. The general authority citation for Act (21 U.S.C. 811),’’ may file a request Posting of Public Comments part 145 continues to read as follows: for hearing or waiver of hearing Please note that all comments Authority: 19 U.S.C. 66, 1202 (General pursuant to 21 CFR 1308.44 and in received are considered part of the Note 3(i), Harmonized Tariff Schedule of the accordance with 21 CFR 1316.45 and/or public record. They will, unless United States), 1624. 1316.47, as applicable. Requests for reasonable cause is given, be made * * * * * hearing and waivers of an opportunity available by the Drug Enforcement

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Administration (DEA) for public (c), requests for a hearing, notices of request for the addition of Thianil to the inspection online at http:// appearance, and waivers of an Index under Minor Species Index File www.regulations.gov. Such information opportunity for a hearing or to (MIF) 900000. Thianil is indicated for includes personal identifying participate in a hearing may be use in the immobilization of non- information (such as your name, submitted only by interested persons, domestic, non-food-producing minor address, etc.) voluntarily submitted by defined as those ‘‘adversely affected or species hoofstock. the commenter. The Freedom of aggrieved by any rule or proposed rule Thiafentanil will be marketed as Information Act (FOIA) applies to all issuable pursuant to section 201 of the thiafentanil oxalate, 4- comments received. If you want to Act (21 U.S.C. 811).’’ 21 CFR 1300.01. (methoxycarbonyl)-4-(N- submit personal identifying information Requests for a hearing and notices of phenylmethoxyacetamido)-1-[2-(2- (such as your name, address, etc.) as participation must conform to the thienyl)ethyl]piperidinium oxalate. part of your comment, but do not want requirements of 21 CFR 1308.44(a) or Thiafentanil should not be confused it to be made publicly available, you (b), as applicable, and include a with (N-phenyl-N-(1-(2- must include the phrase ‘‘PERSONAL statement of the interest of the person in (thiophen-2-yl)ethyl)piperidin-4- IDENTIFYING INFORMATION’’ in the the proceeding and the objections or yl)propionamide), which is currently first paragraph of your comment. You issues, if any, concerning which the listed as a controlled schedule I must also place all of the personal person desires to be heard. Any waiver substance. identifying information you do not want of an opportunity for a hearing must Under the Controlled Substances Act made publicly available in the first conform to the requirements of 21 CFR (CSA), as amended in 2015 by the paragraph of your comment and identify 1308.44(c), including a written Improving Regulatory Transparency for what information you want redacted. statement regarding the interested New Medical Therapies Act (Pub. L. If you want to submit confidential person’s position on the matters of fact 114–89), where the DEA receives business information as part of your and law involved in any hearing. notification from HHS that the Secretary comment, but do not want it to be made Please note that pursuant to 21 U.S.C. has indexed a drug under section 572 of publicly available, you must include the 811(a), the purpose and subject matter the FDCA, the DEA is required to issue phrase ‘‘CONFIDENTIAL BUSINESS of the hearing are restricted to ‘‘(A) an interim final rule controlling the INFORMATION’’ in the first paragraph find[ing] that such drug or other drug not later than 90 days after of your comment. You must also substance has a potential for abuse, and receiving such notification from HHS. prominently identify the confidential (B) mak[ing] with respect to such drug 21 U.S.C. 811(j). Accordingly, the DEA business information to be redacted or other substance the findings is issuing this interim final rule within the comment. prescribed by subsection (b) of section controlling thiafentanil. Comments containing personal 812 of this title for the schedule in When controlling a drug pursuant to identifying information and confidential which such drug is to be placed . . . .’’ section 811(j), the DEA must apply the business information identified as Requests for a hearing and waivers of scheduling criteria of subsections directed above will generally be made participation in the hearing should be 811(b), (c), and (d) and section 812(b). publicly available in redacted form. If a submitted to the DEA on or before the 21 U.S.C. 811(j)(3). In accordance with comment has so much confidential deadline specified above, using the these criteria, the DEA has reviewed the business information or personal address information provided therein. scientific and medical evaluation and identifying information that it cannot be scheduling recommendation provided effectively redacted, all or part of that Background, Legal Authority, and Basis by the HHS, along with all other for This Scheduling Action comment may not be made publicly relevant data, and completed its own available. Comments posted to http:// Thiafentanil, known chemically as 4- eight-factor review document on www.regulations.gov may include any (methoxycarbonyl)-4-(N- thiafentanil pursuant to 21 U.S.C. personal identifying information (such phenylmethoxyacetamido)-1-[2-(2- 811(c). As explained below, based on as name, address, and phone number) thienyl)ethyl]piperidine, a potent these considerations, the DEA included in the text of your electronic , is an analogue of . The concludes that thiafentanil meets the submission that is not identified as product Thianil (thiafentanil oxalate, a criteria for placement in schedule II of directed above as confidential. salt form of thiafentanil) was reviewed the CSA. An electronic copy of this document by the Food and Drug Administration On November 28, 2011, the HHS and supplemental information, (FDA) to determine whether it meets the provided the DEA with its initial including the complete Department of requirements for addition to the Index scientific and medical evaluation and Health and Human Services and Drug of Legally Marketed Unapproved New scheduling recommendation regarding Enforcement Administration eight-factor Animal Drugs for Minor Species (the thiafentanil. Pursuant to 21 U.S.C. analyses, to this interim final rule are Index) (21 U.S.C. 360ccc–1) as set forth 811(b), this document contained an available at http://www.regulations.gov by the Minor Use and Minor Species eight-factor analysis of the abuse for easy reference. Animal Health Act of 2004 (MUMS Act, potential of thiafentanil as a new drug, 2004). The MUMS Act amended the along with the HHS’ recommendation to Request for Hearing, Notice of Federal Food, Drug, and Cosmetic Act control thiafentanil and its salts under Appearance at Hearing, or Waiver of (FDCA) to allow for the legal marketing schedule II of the CSA. Subsequently, Participation in Hearing of unapproved new animal drugs on March 23, 2016, the HHS provided Pursuant to 21 U.S.C. 811(a), this intended for use in minor species. In a the DEA with a supplement to its 2011 action is a formal rulemaking ‘‘on the letter from the Department of Health analysis, which indicated that the HHS/ record after opportunity for a hearing.’’ and Human Services (HHS) dated June FDA planned to add Thianil Such proceedings are conducted 20, 2016, the DEA received notification (thiafentanil oxalate) to the Index for pursuant to the provisions of the that HHS/FDA added Thianil use in the immobilization of non- Administrative Procedure Act (APA), 5 (thiafentanil oxalate) to the Index under domestic, non-food-producing minor U.S.C. 551–559. 21 CFR 1308.41– section 572 of the FDCA. In this same species hoofstock and reiterated their 1308.45; 21 CFR part 1316, subpart D. notification, HHS/FDA stated that on recommendation that thiafentanil be In accordance with 21 CFR 1308.44(a)– June 16, 2016, HHS/FDA granted the placed in schedule II of the CSA. By

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letter dated June 20, 2016, the DEA shares chemical and pharmacological registered for use in the Republic of received notification from the HHS that similarities with schedule II fentanyl South Africa. Thiafentanil oxalate is the FDA had granted the request on June and its analogues, the abuse potential of suggested as a drug of choice in the 16, 2016, for Thianil (thiafentanil thiafentanil is considered similar to that capture of exotic and ungulate wildlife oxalate) to be added to the Index. of schedule II opioid substances such as species. Pursuant to 21 U.S.C. 811(j), and and . 3. The State of Current Scientific based on the HHS recommendation, Pharmacologically, as a potent m Knowledge Regarding Thiafentanil: The MUMS Act indication by the HHS/FDA, agonist, thiafentanil is chemical name of free base thiafentanil and the DEA’s determination, the DEA slightly less potent than carfentanil, is 4-(methoxycarbonyl)-4-(N- finds that thiafentanil has a high which is 100 times more potent than phenylmethoxyacetamido)-1-[2-(2- potential for abuse, a currently accepted fentanyl and 10,000 times more potent thienyl)ethyl]piperidine. It has a medical use with severe restrictions, than . Thiafentanil is a potent molecular formula of C22H28N2O4S and and that abuse of thiafentanil may lead fentanyl analogue. Thus, it is reasonable a molecular weight of 416.52 g/mol with to severe psychological or physical to assume that there will be potentially a Chemical Abstract Registry Number dependence. Accordingly, the DEA is significant diversion of thiafentanil from (CAS) of 101345–60–2. Thiafentanil issuing this interim final rule to add legitimate channels by people who have oxalate is also known as A3080 with a thiafentanil (4-(methoxycarbonyl)-4-(N- access to it, and that thiafentanil would CAS number of 101365–73–5 and has a phenylmethoxyacetamido)-1-[2-(2- be used without medical advice, molecular formula of C24H30N2O8S with thienyl)ethyl]piperidine) and its therefore causing substantial hazards to a molecular weight of 506.57 g/mol. isomers, esters, ethers, salts and salts of the users or to the safety of the Thiafentanil oxalate is a white isomers, esters and ethers, whenever the community if not controlled. The crystalline powder with a melting point existence of such, to schedule II of the chemical and potent opioid-like of 190–192 °C and its salt crystalizes CSA. pharmacological properties of from absolute alcohol. Thiafentanil Included below is a brief summary of thiafentanil predict that its risk to the should not be confused with each factor as analyzed by the HHS and public health is likely to be similar to thiofentanyl (N-phenyl-N-(1-(2- the DEA, and as considered by the DEA fentanyl (schedule II) and its analogues (thiophen-2-yl)ethyl)piperidin-4- in its scheduling action. Please note that such as carfentanil (schedule II), yl)propionamide), which is currently the DEA and HHS analyses, along with sufentanil (schedule II) and alpha- listed as a schedule I substance. the HHS supplement, are available in methylfentanyl (schedule I). 4. Its History and Current Pattern of their entirety under ‘‘Supporting 2. Scientific Evidence of the Drug’s Abuse: According to the HHS’ review, Documents’’ in the public docket for Pharmacological Effects, if Known: there are no reports of actual abuse and According to HHS’ scientific and this interim final rule at http:// misuse of thiafentanil. This may be due www.regulations.gov, under Docket medical review, there are no data on the to the limited use of thiafentanil as an Number ‘‘DEA–375.’’ Full analysis of, effects of thiafentanil in humans. immobilizing agent by trained and citations to, the information Thiafentanil’s effects in humans are veterinarians. referenced in the summary may also be predicted from its effects in animals and Current data from the National found in the supporting and related its chemical and pharmacological Forensic Laboratory System (NFLIS),1 material. similarity to other schedule II potent the System to Retrieve Information from 1. The Drug’s Actual or Relative such as fentanyl and carfentanil. 2 Potential for Abuse: Thiafentanil is a The HHS eight-factor review Drug Evidence (STRIDE), and the chemical substance that has not been document described a study directly STARLiMS databases show that there is marketed in the United States, however, comparing the immobilizing effects of no evidence of law enforcement it is approved and marketed in the thiafentanil (15 mg) and carfentanil (2 or encounters of thiafentanil in the United Republic of South Africa as a salt form 4 mg) in elk in which thiafentanil States. However, thiafentanil’s under the brand name Thianil produced a faster immobilization effect pharmacological and structural (thiafentanil oxalate). There is no (0.7 to 2.2 minutes) than carfentanil. In properties suggest that its pattern of information available which details addition, the elk returned to standing abuse would be similar to other potent actual abuse of thiafentanil. 0.9 to 1.4 minutes faster under the According to the HHS, thiafentanil is thiafentanil condition. This study 1 The National Forensic Laboratory System a synthetic analogue of fentanyl and is (NFLIS) is a program of the DEA, Office of appears to support a faster Diversion Control. NFLIS systematically collects structurally related to other fentanyl- immobilization and recovery time with drug identification results and associated like opioids such as sufentanil thiafentanil relative to carfentanil. information from drug cases submitted to and (schedule II) and carfentanil (schedule However, the authors stated that the role analyzed by State and local forensic laboratories. II). It acts as a potent m-opioid receptor NFLIS represents an important resource in of the increased dose of thiafentanil is monitoring illicit drug abuse and trafficking, agonist and produces strong morphine- unknown. including the diversion of legally manufactured like effects in animals. It is only Animal studies described by the HHS pharmaceuticals into illegal markets. NFLIS is a intended for the immobilization of non- demonstrated that the effects of comprehensive information system that includes domestic, non-food-producing minor thiafentanil and carfentanil are data from forensic laboratories that handle approximately 90% of an estimated 1.0 million species hoofstock. Thiafentanil has been completely reversed by . As a distinct annual State and local drug analysis cases. used in a manner similar to other opioid m-opioid receptor antagonist, naltrexone NFLIS includes drug chemistry results from immobilizing agents such as can reverse the effects of a variety of completed analyses only. While NFLIS data is not hydrochloride (schedule II) and opioid drugs including thiafentanil and direct evidence of abuse, it can lead to an inference that a drug has been diverted and abused. See 76 carfentanil (schedule II), which are carfentanil. Those studies suggest that FR 77330, 77332, Dec. 12, 2011. approved only for veterinary use as thiafentanil possesses a neuro- 2 The System to Retrieve Information from Drug animal immobilization agents. The pharmacological mechanism of action Evidence (STRIDE) is a database of drug exhibits abuse potential of thiafentanil has not similar to other schedule II opioid drugs sent to DEA laboratories for analysis. Exhibits from the database are from the DEA, other federal been evaluated in humans or in animal with a high abuse potential. agencies, and local law enforcement agencies. behavioral models that are predictors of According to HHS’ review, Thianil Reporting via STRIDE ceased on September 30, abuse by humans. Because thiafentanil (thiafentanil) is currently approved and 2014. STRIDE was succeeded by STARLiMS.

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schedule II m-opioid receptor agonists used unless an adequate amount of 21 U.S.C. 812(b). After consideration of such as fentanyl and carfentanil. reversal agent (naltrexone the analysis and recommendation of the 5. The Scope, Duration, and hydrochloride) is immediately available. Assistant Secretary for Health of the Significance of Abuse: An assessment of HHS also describes the risk of HHS and review of all available data, the scope, duration, and significance of thiafentanil intoxication upon ingestion the Acting Administrator of the DEA, thiafentanil abuse is not available since of animals immobilized with pursuant to 21 U.S.C. 812(b)(2), finds it has only been used in a limited thiafentanil. The label information that: market. However, as stated in the HHS states that thiafentanil is not intended 1. Thiafentanil has a high potential for review, the structural and for human or animal consumption or in abuse. Based on its structural and pharmacological properties of non-food producing minor species that pharmacological properties, thiafentanil thiafentanil suggest that it could lead to become eligible for consumption by has an abuse potential that is an abuse pattern with a scope, duration, humans or food-producing animals. comparable to other schedule II opioid and significance of abuse similar to that Because thiafentanil, similar to drugs such as fentanyl, carfentanil, and observed with other opioid drugs and carfentanil, etorphine hydrochloride sufentanil; opioid analogues if it were marketed in and , is a potent m-opioid 2. FDA determined that Thianil a non-controlled status or were the receptor agonist, it will be subject to (thiafentanil oxalate) meets the subject of clandestine synthesis. The specialized handling, distribution and requirements for addition to the Index HHS and DEA note that thiafentanil is storage procedures similar to those as set forth by the MUMS Act, 2004 and not known to be or to have been the applicable for carfentanil, etorphine accordingly added Thianil (thiafentanil subject of abuse in the United States. hydrochloride and diprenorphine as set oxalate) to the Index of Legally 6. What, if any, Risk There is to the forth in 21 CFR parts 1301 and 1305. As Marketed Unapproved New Animal Public Health: The HHS review a result, this interim final rule revises 21 Drugs for Minor Species (the Index) indicates that thiafentanil presents a CFR 1301.74(g), 1301.75(e), 1305.07 under section 572 of the Federal Food, significant risk to the public health and, introductory text and paragraph (a), and Drug, and Cosmetic Act. Thianil in this vein, that thiafentanil should 1305.17(d) to include ‘‘thiafentanil.’’ (thiafentanil oxalate) will be legally only be used in certain animals for very 7. Its Psychic or Physiological marketed in the United States and will limited purposes and with extreme Dependence Liability: HHS’ review have an accepted medical use with caution. Based on the review of the states that the structural and severe restrictions; 3 and structural and pharmacological pharmacological properties of 3. Due to the chemical and properties of thiafentanil, the HHS thiafentanil suggest that it possesses a pharmacological similarities of concluded that the abuse of thiafentanil psychic and physiological dependence thiafentanil to other schedule II fentanyl is likely to pose a similar risk to public liability that is similar to other schedule derivatives, abuse of thiafentanil may health as that of other potent opioid II related m-opioid receptor agonist lead to severe psychological or physical drugs such as sufentanil (schedule II), drugs such as sufentanil, fentanyl and dependence. fentanyl (schedule II), carfentanil carfentanil. Based on these findings, the Acting (schedule II) and clandestinely As cited by the HHS review, a double- Administrator of the DEA concludes synthesized alpha-methylfentanyl blind abuse liability study examining that thiafentanil, including its isomers, (schedule I). Thus, inappropriate use of intravenous fentanyl, , esters, ethers, salts and salts of isomers, thiafentanil poses a high risk to the , morphine, and in esters and ethers whenever the public health. Among other things, HHS -maintained patients existences of such isomers, esters, noted that as a fentanyl derivative, and reported that fentanyl produced ethers, and salts is possible warrants assuming that thiafentanil can be subjective effects similar to heroin control in schedule II of the CSA. 21 aerosolized, the use of thiafentanil (schedule I) on several outcome U.S.C. 812(b)(2). presents a significant risk to the public measures indicating that the two drugs health. produce similar subjective effects. It Requirements for Handling HHS described that thiafentanil’s also demonstrates the psychic Thiafentanil labeling indicates that it is solely dependence liability of fentanyl, and Thiafentanil is subject to the CSA’s intended for use by zoologic, wildlife, or thiafentanil is expected to produce schedule II regulatory controls and exotic animal veterinarians or field effects similar to fentanyl and to present administrative, civil, and criminal biologists who have received training a similar risk of psychic and sanctions applicable to the manufacture, and are supervised by veterinarians. The physiological dependence. There has distribution, reverse distribution, sponsor recommends the use of been a major increase in abuse of dispensing, importing, exporting, handling protocols similar to those in opioids in the United States research, and conduct of instructional place for other scheduled potent opioids (HHS review document, 2011; Compton such as carfentanil. HHS further and Volkow, 2006). Thiafentanil, similar 3 According to the HHS analysis, ‘‘[u]se of a new indicated that thiafentanil should be to these opioid analgesics, presents a animal indexed drug is subject to significant handled in teams consisting of at least risk of severe psychic and physiological restrictions. For example, use of an indexed new two individuals knowledgeable about dependence. animal drug for minor species is limited to a minor m species for which there is a reasonable certainty the hazards of working with potent - 8. Whether the Substance is an that the animal or edible products from the animal opioid agonist substances. Personal Immediate Precursor of a Substance will not be consumed by humans or food producing protective equipment such as latex Already Controlled under the CSA: animals. 21 U.S.C. § 360ccc–l(a)(1). The requester gloves and protective eyewear should be must label, distribute, and promote the new animal Thiafentanil is not considered an drug in accordance with the Index entry, and the used and syringes must be disposed of immediate precursor of any controlled FDA may remove a new animal drug from the Index properly. If exposure to thiafentanil substance. if the conditions and limitations of use have not occurs in a remote or distant been followed. 21 U.S.C. 360ccc–l(d)(l)(G); (f)(l)(F). environment, veterinary naltrexone is Determination of Appropriate Schedule The labeling of an indexed new animal drug must prominently state that the extra-label use of the recommended for use as a reversal The CSA lists the findings required to product is prohibited. 21 U.S.C. 360ccc–l(h). Such agent. The label information will further place a drug or other substance in any restrictions are not imposed upon approved human state that thiafentanil must never be particular schedule (I, II, III, IV, or V). or animal drugs.’’

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activities and chemical analysis with, (including thiafentanil) on hand on the 12. Liability. Any activity involving and possession involving schedule II date the registrant first engages in the thiafentanil not authorized by, or in substances, including the following: handling of controlled substances, violation of, the CSA or its 1. Registration. Any person who pursuant to 21 U.S.C. 827 and 958, and implementing regulations, is unlawful, desires to handle thiafentanil in accordance with 21 CFR 1304.03, and may subject the person to (manufacture, distribute, reverse 1304.04, and 1304.11. administrative, civil, and/or criminal distribute, dispense, import, export, After the initial inventory, every DEA sanctions. engage in research, or conduct registrant must take a new inventory of Regulatory Analyses instructional activities or chemical all stocks of controlled substances analysis with, or possess), must be (including thiafentanil) on hand every Administrative Procedure Act registered with the DEA to conduct such two years, pursuant to 21 U.S.C. 827 Public Law 114–89 was signed into activities pursuant to 21 U.S.C. 822, and 958, and in accordance with 21 CFR law, amending 21 U.S.C. 811. This 823, 957, and 958 and in accordance 1304.03, 1304.04, and 1304.11. amendment provides that in cases with 21 CFR parts 1301 and 1312. 7. Records and Reports. Every DEA where a new drug is (1) approved or 2. Quota. Only registered registrant must maintain records and indexed by the Department of Health manufacturers are permitted to submit reports for thiafentanil, or and Human Services (HHS) and (2) HHS manufacture thiafentanil in accordance products containing thiafentanil, recommends control in CSA schedule with a quota assigned pursuant to 21 pursuant to 21 U.S.C. 827 and 958(e), II–V, the DEA shall issue an interim U.S.C. 826 and in accordance with 21 and in accordance with 21 CFR parts final rule scheduling the drug within 90 CFR part 1303. 1304, 1312, and 1317. days. Additionally, the law specifies 3. Disposal of stocks. Upon obtaining 8. Orders for thiafentanil. Every DEA that the rulemaking shall become a schedule II registration to handle registrant who distributes thiafentanil is immediately effective as an interim final thiafentanil, and if subsequently, any required to comply with order form rule without requiring the DEA to person who does not desire or is not demonstrate good cause. Therefore, the able to maintain a schedule II requirements, pursuant to 21 U.S.C. 828, DEA has determined that the notice and registration must surrender all and in accordance with 21 CFR part comment requirements of section 553 of quantities of currently held thiafentanil, 1305. the APA, 5 U.S.C. 553, do not apply to or may transfer all quantities of 9. Prescriptions and other dispensing. this scheduling action. currently held thiafentanil to a person All prescriptions for thiafentanil or registered with the DEA in accordance products containing thiafentanil must Executive Orders 12866, Regulatory with 21 CFR part 1317, in addition to comply with 21 U.S.C. 829, and be Planning and Review, and 13563, all other applicable federal, state, local, issued in accordance with 21 CFR parts Improving Regulation and Regulatory and tribal laws. 1306 and 1311, subpart C. Moreover, Review 4. Security. Thiafentanil is subject to given that thiafentanil is not the subject of an approved new drug application In accordance with Public Law 114– schedule II security requirements and 89, this scheduling action is subject to must be handled and stored pursuant to under the FDCA, and that it is only allowed under the MUMS Act formal rulemaking procedures 21 U.S.C. 821 and 823, and in performed ‘‘on the record after accordance with 21 CFR 1301.71– amendments to the FDCA to be marketed for extremely limited use in opportunity for a hearing,’’ which are 1301.93. conducted pursuant to the provisions of 5. Labeling and Packaging. All labels, minor species, DEA would not consider any dispensing of thiafentanil for 5 U.S.C. 556 and 557. The CSA sets labeling, and packaging for commercial forth the procedures and criteria for containers of thiafentanil must comply human use to be for a legitimate medical purpose within the meaning of the CSA. scheduling a drug or other substance. with 21 U.S.C. 825 and 958(e), and be Such actions are exempt from review by in accordance with 21 CFR part 1302. In Likewise, DEA would not consider any dispensing of thiafentanil for animal use the Office of Management and Budget addition, thiafentanil is subject to (OMB) pursuant to section 3(d)(1) of additional labeling requirements beyond the scope of the drug’s labeling authorized under the MUMS Act Executive Order 12866 and the provided by FDA. Thiafentanil must be principles reaffirmed in Executive Order amendments to the FDCA to be for a labeled, distributed, and promoted in 13563. accordance with the Index entry of the legitimate medical purpose within the new animal drug and the FDA may meaning of the CSA. Executive Order 12988, Civil Justice remove a new animal drug from the 10. Manufacturing and Distributing. Reform Index if the conditions and limitations In addition to the general requirements This regulation meets the applicable of use have not been followed. 21 U.S.C. of the CSA and DEA regulations that are standards set forth in sections 3(a) and 360ccc–l(d)(l)(G); (f)(l)(F). The labeling applicable to manufacturers and 3(b)(2) of Executive Order 12988 to of an indexed new animal drug must distributors of schedule II controlled eliminate drafting errors and ambiguity, prominently state that the extra-label substances, such registrants should be minimize litigation, provide a clear legal use of the product is prohibited. 21 advised that (consistent with the standard for affected conduct, and U.S.C. 360ccc–l(h). foregoing considerations) any promote simplification and burden 6. Inventory. Every DEA registrant manufacturing or distribution of reduction. who desires to possess any quantity of thiafentanil may only be for the thiafentanil must take an inventory of legitimate purposes consistent with the Executive Order 13132, Federalism thiafentanil on hand, pursuant to 21 drug’s labeling authorized under the This rulemaking does not have U.S.C. 827 and 958, and in accordance MUMS Act, or for research activities federalism implications warranting the with 21 CFR 1304.03, 1304.04, and authorized by the FDCA and CSA. application of Executive Order 13132. 1304.11. 11. Importation and Exportation. All The rule does not have substantial Any person who becomes registered importation and exportation of direct effects on the States, on the with the DEA to handle thiafentanil thiafentanil must be in compliance with relationship between the national must take an initial inventory of all 21 U.S.C. 952, 953, 957, and 958, and government and the States, or on the stocks of controlled substances in accordance with 21 CFR part 1312. distribution of power and

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responsibilities among the various Business Regulatory Enforcement § 1301.75 Physical security controls for levels of government. Fairness Act of 1996 (Congressional practitioners. Review Act (CRA)). This rule will not * * * * * Executive Order 13175, Consultation result in: An annual effect on the and Coordination With Indian Tribal (e) Thiafentanil, carfentanil, etorphine economy of $100,000,000 or more; a Governments hydrochloride and diprenorphine shall major increase in costs or prices for be stored in a safe or steel cabinet This rule does not have tribal consumers, individual industries, equivalent to a U.S. Government Class implications warranting the application Federal, State, or local government V security container. of Executive Order 13175. It does not agencies, or geographic regions; or have substantial direct effects on one or significant adverse effects on PART 1305—ORDERS FOR SCHEDULE more Indian tribes, on the relationship competition, employment, investment, I AND II CONTROLLED SUBSTANCES between the Federal government and productivity, innovation, or on the Indian tribes, or on the distribution of ability of U.S.-based companies to ■ 4. The authority citation for 21 CFR power and responsibilities between the compete with foreign based companies part 1305 continues to read as follows: Federal government and Indian tribes. in domestic and export markets. Authority: 21 U.S.C. 821, 828, 871(b), Regulatory Flexibility Act However, pursuant to the CRA, the DEA unless otherwise noted. has submitted a copy of this interim In accordance with 5 U.S.C. 603(a), final rule to both Houses of Congress ■ 5. In § 1305.07, revise the introductory ‘‘[w]henever an agency is required by [5 and to the Comptroller General. text and paragraph (a) to read as follows: U.S.C. 553], or any other law, to publish general notice of proposed rulemaking List of Subjects § 1305.07 Special procedure for filling certain orders. for any proposed rule, or publishes a 21 CFR Part 1301 notice of proposed rulemaking for an A supplier of thiafentanil, carfentanil, interpretive rule involving the internal Administrative practice and etorphine hydrochloride, or revenue laws of the United States, the procedure, Drug traffic control, Security diprenorphine, if he or she determines agency shall prepare and make available measures. that the purchaser is a veterinarian engaged in zoo and exotic animal for public comment an initial regulatory 21 CFR Part 1305 flexibility analysis.’’ As noted in the practice, wildlife management above discussion regarding applicability Drug traffic control, Reporting and programs, or research, and is authorized of the Administrative Procedure Act, the recordkeeping requirements. by the Administrator to handle these substances, may fill the order in DEA has determined that the notice and 21 CFR Part 1308 comment requirements of section 553 of accordance with the procedures set the APA, 5 U.S.C. 553, do not apply to Administrative practice and forth in § 1305.17 except that: this scheduling action. Consequently, procedure, Drug traffic control, (a) A DEA Form 222 or an electronic the RFA does not apply to this interim Reporting and recordkeeping order for thiafentanil, carfentanil, final rule. requirements. etorphine hydrochloride, and diprenorphine must contain only these Unfunded Mandates Reform Act of 1995 For the reasons set out above, the DEA amends 21 CFR parts 1301, 1305 and substances in reasonable quantities. In accordance with the Unfunded 1308 as follows: * * * * * Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1501 et seq., the DEA has PART 1301—REGISTRATION OF ■ 6. In § 1305.17, revise paragraph (d) to determined and certifies that this action MANUFACTURERS, DISTRIBUTORS, read as follows: would not result in any Federal AND DISPENSERS OF CONTROLLED § 1305.17 Preservation of DEA Forms 222. mandate that may result ‘‘in the SUBSTANCES * * * * * expenditure by State, local, and tribal governments, in the aggregate, or by the ■ 1. The authority citation for 21 CFR (d) The supplier of thiafentanil, private sector, of $100,000,000 or more part 1301 continues to read as follows: carfentanil, etorphine hydrochloride, (adjusted for inflation) in any one year.’’ and diprenorphine must maintain DEA Authority: 21 U.S.C. 821, 822, 823, 824, Forms 222 for these substances Therefore, neither a Small Government 831, 871(b), 875, 877, 886a, 951, 952, 953, Agency Plan nor any other action is 956, 957, 958, 965. separately from all other DEA Forms required under UMRA of 1995. 222 and records required to be ■ 2. In § 1301.74, revise paragraph (g) to maintained by the registrant. Paperwork Reduction Act of 1995 read as follows: This action does not impose a new PART 1308—SCHEDULES OF § 1301.74 Other security controls for non- CONTROLLED SUBSTANCES collection of information requirement practitioners; narcotic treatment programs under the Paperwork Reduction Act of and compounders for narcotic treatment ■ 1995. 44 U.S.C. 3501–3521. This action programs. 7. The authority citation for 21 CFR part 1308 continues to read as follows: would not impose recordkeeping or * * * * * reporting requirements on State or local (g) Before the initial distribution of Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted. governments, individuals, businesses, or thiafentanil, carfentanil, etorphine organizations. An agency may not hydrochloride and/or diprenorphine to ■ 8. In § 1308.12, add paragraph (c)(29) conduct or sponsor, and a person is not any person, the registrant must verify to read as follows: required to respond to, a collection of that the person is authorized to handle information unless it displays a the substance(s) by contacting the Drug § 1308.12 Schedule II. currently valid OMB control number. Enforcement Administration. * * * * * Congressional Review Act * * * * * (c) * * * This rule is not a major rule as ■ 3. In § 1301.75, revise paragraph (e) to (29) Thiafentanil ...... 9729 defined by section 804 of the Small read as follows: * * * * *

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Dated: August 18, 2016. other amendments, the July 2015 Final supplementary information to the July Chuck Rosenberg, Rule modified provisions relating to the 2015 Final Rule discusses coverage of Acting Administrator. optional mechanism a creditor may use overdraft products. [FR Doc. 2016–20463 Filed 8–25–16; 8:45 am] when assessing whether a consumer is The MLA regulation defines BILLING CODE 4410–09–P a ‘‘covered borrower,’’ modified the ‘‘consumer credit’’ as credit offered or disclosures that a creditor must provide extended to a covered borrower to a covered borrower, and implemented primarily for personal, family or DEPARTMENT OF DEFENSE the enforcement provisions of the MLA. household purposes that is either Subsequently, the Department subject to a finance charge or payable by Office of the Secretary received requests to clarify its a written agreement in more than four interpretation of points raised in the installments, with some exceptions. The 32 CFR Part 232 July 2015 Final Rule. The Department is exceptions include: Residential issuing this interpretive rule to inform mortgage transactions; purchase money [Docket ID: DOD–2013–OS–0133] the public of its views. The Department credit for a vehicle or personal property RIN 0790–ZA11 has chosen to provide this guidance in that is secured by the purchased vehicle the form of a question and answer or personal property; certain Military Lending Act Limitations on document to assist industry in transactions exempt from Regulation Z Terms of Consumer Credit Extended to complying with the July 2015 Final (not including transactions exempt Service Members and Dependents Rule. This interpretive rule does not under 12 CFR 1026.29); and credit substantively change the regulation extended to non-covered borrowers AGENCY: Under Secretary of Defense for implementing the MLA, but rather consistent with 32 CFR 232.5(b). Personnel and Readiness, Department of merely states the Department’s Although coverage by the MLA and the Defense. preexisting interpretations of an existing MLA regulation is not completely ACTION: Interpretive rule. regulation. Therefore, under 5 U.S.C. identical to that of TILA and Regulation 553(b)(A), this rulemaking is exempt SUMMARY: The Department of Defense Z, the July 2015 Final Rule amends the from the notice and comment (Department) is interpreting its definition of consumer credit under the requirements of the Administrative regulation implementing the Military MLA to be more consistent with how Procedure Act, and, pursuant to 5 U.S.C. Lending Act (the MLA). The MLA as credit is defined under TILA. The 553(d)(2), this rule is effective implemented by the Department, limits supplementary information to the July immediately upon publication in the 2015 Final Rule states: the military annual percentage rate Federal Register. (MAPR) that a creditor may charge to a As proposed, the Department is amending maximum of 36 percent, requires certain II. Interpretations of the Department its regulation so that, in general, consumer disclosures, and provides other The following questions and answers credit covered under the MLA would be substantive consumer protections on represent official interpretations of the defined consistently with credit that for decades has been subject to TILA, namely: ‘‘consumer credit’’ extended to Service Department on issues related to 32 CFR members and their families. On July 22, Credit offered or extended to a covered part 232. For ease of reference, the borrower primarily for personal, family, or 2015, the Department amended its following terms are used throughout household purposes, and that is (i) subject to regulation primarily for the purpose of this document: MLA refers to the a finance charge or (ii) payable by a written extending the protections of the MLA to Military Lending Act (codified at 10 agreement in more than four installments.5 a broader range of closed-end and open- U.S.C. 987); MAPR refers to the military The MLA regulation also defines end credit products (the July 2015 Final annual percentage rate, as defined in 32 ‘‘closed-end credit’’ and ‘‘open-end Rule). This interpretive rule provides CFR 232.3(p); TILA refers to the Truth credit’’ with express references to the guidance on certain questions the in Lending Act (codified at 15 U.S.C. definitions of the same terms in Department has received regarding 1601 et seq.); Regulation Z refers to the Regulation Z. compliance with the July 2015 Final regulation, and interpretations thereof, The supplementary information to the Rule. issued by the Consumer Financial July 2015 Final Rule illustrates how to DATES: Effective Date: August 26, 2016. Protection Bureau (or the Board of apply these standards specifically with FOR FURTHER INFORMATION CONTACT: Governors of the Federal Reserve respect to overdraft products and Marcus Beauregard, 571–372–5357. System, as applicable) to implement services.6 It states that consistent with TILA, as defined in 32 CFR 232.3(s); SUPPLEMENTARY INFORMATION: Regulation Z, an overdraft line of credit DMDC refers to the Defense Manpower with a finance charge is a covered I. Background and Purpose Data Center. consumer credit product when: It is In July, 2015, the Department of 1. What types of overdraft products are offered to a covered borrower; the credit Defense (Department) issued a final within the scope of 32 CFR 232.3(f) extended by the creditor is primarily for rule 1 (the July 2015 Final Rule) defining ‘‘consumer credit’’? personal, family, or household amending its regulation implementing purposes; it is used to pay an item that 2 Answer: The MLA regulation the Military Lending Act (MLA) generally directs creditors to look to overdraws an asset account and results primarily for the purpose of extending provisions of TILA and its in a fee or charge to the covered the protections of the MLA to a broader implementing regulation, Regulation Z, borrower; and, the extension of credit range of closed-end and open-end credit in determining whether a product or products, rather than the limited credit connection with certain credit features offered in service is considered ‘‘consumer credit’’ conjunction with prepaid card accounts). It is the products that had been defined as 4 3 for purposes of the MLA. Also, the Department’s intention that this part should ‘‘consumer credit.’’ Moreover, among wherever possible be interpreted consistently with 4 The Department notes that the Consumer Regulation Z as it evolves in order to harmonize the 1 80 FR 435560. Financial Protection Bureau may from time to time two regulations and thereby minimize compliance 2 10 U.S.C. 987. revise Regulation Z. See, e.g., 79 FR 77102 (Dec. 23, burden. 3 32 CFR 232.3(b) as implemented in a final rule 2014) (proposing to revise the definition of finance 5 80 FR 43563 (footnotes omitted). published at 72 FR 50580 (Aug. 31, 2007). charge with respect to charges imposed in 6 80 FR 43579–43580.

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