Schedules of Controlled Substances: Placement of Thiafentanil Into Schedule II, 58834-58840 [2016-20463]

Download as PDF 58834 Federal Register / Vol. 81, No. 166 / Friday, August 26, 2016 / Rules and Regulations 10. Amend § 143.23 by revising paragraph (j) and adding paragraph (k) to read as follows: ■ § 143.23 Form of entry. * * * * * (j) Except for mail importations (see §§ 145.31 and 145.32 of this chapter), or in the case of personal written or oral declarations (see §§ 148.12, 148.13, and 148.62 of this chapter), a shipment of merchandise that qualifies for informal entry under 19 U.S.C. 1498 may be entered, including the information listed in paragraph (k) of this section, by presenting the bill of lading or a manifest listing each bill of lading when: (1) The value of the shipment does not exceed $100 in the case of a bona fide gift from a person in a foreign country to a person in the United States and the shipment meets the requirements in § 10.152 of this chapter (see § 10.152 of this chapter); (2) The value of the shipment does not exceed $200 in the case of articles (including bona fide gifts) from the Virgin Islands, Guam, and American Samoa and the shipment meets the requirements in § 10.152 of this chapter (see § 10.152 of this chapter); or (3) The value of the shipment does not exceed $800 and the shipment satisfies the requirements in § 10.151 of this chapter (see §§ 10.151 and 128.24(e) of this chapter). (k) The following information is required to be filed as a part of entry made under paragraph (j) of this section: (1) Country of origin of the merchandise; (2) Shipper name, address and country; (3) Ultimate consignee name and address; (4) Specific description of the merchandise; (5) Quantity; (6) Shipping weight; and (7) Value. 11. Amend § 143.26 by removing the figure ‘‘$200’’ and adding in its place ‘‘$800’’ in two places each in paragraphs (a) and (b). ■ ehiers on DSK5VPTVN1PROD with RULES PART 145—MAIL IMPORTATIONS 12. The general authority citation for part 145 continues to read as follows: ■ Authority: 19 U.S.C. 66, 1202 (General Note 3(i), Harmonized Tariff Schedule of the United States), 1624. * * * VerDate Sep<11>2014 * * 14:39 Aug 25, 2016 Jkt 238001 § 145.31 [Amended] 13. Amend § 145.31 by removing the figure ‘‘$200’’ and adding in its place ‘‘$800’’ in the section heading and text. ■ R. Gil Kerlikowske, Commissioner, U.S. Customs and Border Protection. Approved: August 23, 2016. Timothy E. Skud, Assistant Secretary of the Treasury. [FR Doc. 2016–20581 Filed 8–25–16; 8:45 am] BILLING CODE 9111–14–P DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Parts 1301, 1305, and 1308 [Docket No. DEA–375] Schedules of Controlled Substances: Placement of Thiafentanil Into Schedule II Drug Enforcement Administration, Department of Justice. ACTION: Interim final rule with request for comments. AGENCY: The Drug Enforcement Administration is placing the substance thiafentanil (4-(methoxycarbonyl)-4-(Nphenmethoxyacetamido)-1-[2(thienyl)ethyl]piperidine), including its isomers, esters, ethers, salts and salts of isomers, esters and ethers as possible, into schedule II of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act, as revised by the Improving Regulatory Transparency for New Medical Therapies Act which was signed into law on November 25, 2015. DATES: The effective date of this rule is August 26, 2016. Interested persons may file written comments on this rule in accordance with 21 U.S.C. 811(j)(3) and 21 CFR 1308.43(g). Electronic comments must be submitted, and written comments must be postmarked, on or before September 26, 2016. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period. Interested persons, defined at 21 CFR 1300.01 as those ‘‘adversely affected or aggrieved by any rule or proposed rule issuable pursuant to section 201 of the Act (21 U.S.C. 811),’’ may file a request for hearing or waiver of hearing pursuant to 21 CFR 1308.44 and in accordance with 21 CFR 1316.45 and/or 1316.47, as applicable. Requests for hearing and waivers of an opportunity SUMMARY: PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 for a hearing or to participate in a hearing must be received on or before September 26, 2016. ADDRESSES: To ensure proper handling of comments, please reference ‘‘Docket No. DEA–375’’ on all correspondence, including any attachments. • Electronic comments: The Drug Enforcement Administration encourages that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the Web page or attach a file for lengthier comments. Please go to http://www.regulations.gov and follow the online instructions at that site for submitting comments. Upon completion of your submission, you will receive a Comment Tracking Number for your comment. Please be aware that submitted comments are not instantaneously available for public view on Regulations.gov. If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment. • Paper comments: Paper comments that duplicate the electronic submission are not necessary and are discouraged. Should you wish to mail a paper comment in lieu of an electronic comment, it should be sent via regular or express mail to: Drug Enforcement Administration, Attn: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. • Hearing requests: All requests for hearing and waivers of participation must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing and waivers of participation should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Office of Diversion Control, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598–6812. SUPPLEMENTARY INFORMATION: Posting of Public Comments Please note that all comments received are considered part of the public record. They will, unless reasonable cause is given, be made available by the Drug Enforcement E:\FR\FM\26AUR1.SGM 26AUR1 Federal Register / Vol. 81, No. 166 / Friday, August 26, 2016 / Rules and Regulations ehiers on DSK5VPTVN1PROD with RULES Administration (DEA) for public inspection online at http:// www.regulations.gov. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. The Freedom of Information Act (FOIA) applies to all comments received. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be made publicly available, you must include the phrase ‘‘PERSONAL IDENTIFYING INFORMATION’’ in the first paragraph of your comment. You must also place all of the personal identifying information you do not want made publicly available in the first paragraph of your comment and identify what information you want redacted. If you want to submit confidential business information as part of your comment, but do not want it to be made publicly available, you must include the phrase ‘‘CONFIDENTIAL BUSINESS INFORMATION’’ in the first paragraph of your comment. You must also prominently identify the confidential business information to be redacted within the comment. Comments containing personal identifying information and confidential business information identified as directed above will generally be made publicly available in redacted form. If a comment has so much confidential business information or personal identifying information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to http:// www.regulations.gov may include any personal identifying information (such as name, address, and phone number) included in the text of your electronic submission that is not identified as directed above as confidential. An electronic copy of this document and supplemental information, including the complete Department of Health and Human Services and Drug Enforcement Administration eight-factor analyses, to this interim final rule are available at http://www.regulations.gov for easy reference. Request for Hearing, Notice of Appearance at Hearing, or Waiver of Participation in Hearing Pursuant to 21 U.S.C. 811(a), this action is a formal rulemaking ‘‘on the record after opportunity for a hearing.’’ Such proceedings are conducted pursuant to the provisions of the Administrative Procedure Act (APA), 5 U.S.C. 551–559. 21 CFR 1308.41– 1308.45; 21 CFR part 1316, subpart D. In accordance with 21 CFR 1308.44(a)– VerDate Sep<11>2014 16:25 Aug 25, 2016 Jkt 238001 (c), requests for a hearing, notices of appearance, and waivers of an opportunity for a hearing or to participate in a hearing may be submitted only by interested persons, defined as those ‘‘adversely affected or aggrieved by any rule or proposed rule issuable pursuant to section 201 of the Act (21 U.S.C. 811).’’ 21 CFR 1300.01. Requests for a hearing and notices of participation must conform to the requirements of 21 CFR 1308.44(a) or (b), as applicable, and include a statement of the interest of the person in the proceeding and the objections or issues, if any, concerning which the person desires to be heard. Any waiver of an opportunity for a hearing must conform to the requirements of 21 CFR 1308.44(c), including a written statement regarding the interested person’s position on the matters of fact and law involved in any hearing. Please note that pursuant to 21 U.S.C. 811(a), the purpose and subject matter of the hearing are restricted to ‘‘(A) find[ing] that such drug or other substance has a potential for abuse, and (B) mak[ing] with respect to such drug or other substance the findings prescribed by subsection (b) of section 812 of this title for the schedule in which such drug is to be placed . . . .’’ Requests for a hearing and waivers of participation in the hearing should be submitted to the DEA on or before the deadline specified above, using the address information provided therein. Background, Legal Authority, and Basis for This Scheduling Action Thiafentanil, known chemically as 4(methoxycarbonyl)-4-(Nphenylmethoxyacetamido)-1-[2-(2thienyl)ethyl]piperidine, a potent opioid, is an analogue of fentanyl. The product Thianil (thiafentanil oxalate, a salt form of thiafentanil) was reviewed by the Food and Drug Administration (FDA) to determine whether it meets the requirements for addition to the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (the Index) (21 U.S.C. 360ccc–1) as set forth by the Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act, 2004). The MUMS Act amended the Federal Food, Drug, and Cosmetic Act (FDCA) to allow for the legal marketing of unapproved new animal drugs intended for use in minor species. In a letter from the Department of Health and Human Services (HHS) dated June 20, 2016, the DEA received notification that HHS/FDA added Thianil (thiafentanil oxalate) to the Index under section 572 of the FDCA. In this same notification, HHS/FDA stated that on June 16, 2016, HHS/FDA granted the PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 58835 request for the addition of Thianil to the Index under Minor Species Index File (MIF) 900000. Thianil is indicated for use in the immobilization of nondomestic, non-food-producing minor species hoofstock. Thiafentanil will be marketed as thiafentanil oxalate, 4(methoxycarbonyl)-4-(Nphenylmethoxyacetamido)-1-[2-(2thienyl)ethyl]piperidinium oxalate. Thiafentanil should not be confused with thiofentanyl (N-phenyl-N-(1-(2(thiophen-2-yl)ethyl)piperidin-4yl)propionamide), which is currently listed as a controlled schedule I substance. Under the Controlled Substances Act (CSA), as amended in 2015 by the Improving Regulatory Transparency for New Medical Therapies Act (Pub. L. 114–89), where the DEA receives notification from HHS that the Secretary has indexed a drug under section 572 of the FDCA, the DEA is required to issue an interim final rule controlling the drug not later than 90 days after receiving such notification from HHS. 21 U.S.C. 811(j). Accordingly, the DEA is issuing this interim final rule controlling thiafentanil. When controlling a drug pursuant to section 811(j), the DEA must apply the scheduling criteria of subsections 811(b), (c), and (d) and section 812(b). 21 U.S.C. 811(j)(3). In accordance with these criteria, the DEA has reviewed the scientific and medical evaluation and scheduling recommendation provided by the HHS, along with all other relevant data, and completed its own eight-factor review document on thiafentanil pursuant to 21 U.S.C. 811(c). As explained below, based on these considerations, the DEA concludes that thiafentanil meets the criteria for placement in schedule II of the CSA. On November 28, 2011, the HHS provided the DEA with its initial scientific and medical evaluation and scheduling recommendation regarding thiafentanil. Pursuant to 21 U.S.C. 811(b), this document contained an eight-factor analysis of the abuse potential of thiafentanil as a new drug, along with the HHS’ recommendation to control thiafentanil and its salts under schedule II of the CSA. Subsequently, on March 23, 2016, the HHS provided the DEA with a supplement to its 2011 analysis, which indicated that the HHS/ FDA planned to add Thianil (thiafentanil oxalate) to the Index for use in the immobilization of nondomestic, non-food-producing minor species hoofstock and reiterated their recommendation that thiafentanil be placed in schedule II of the CSA. By E:\FR\FM\26AUR1.SGM 26AUR1 ehiers on DSK5VPTVN1PROD with RULES 58836 Federal Register / Vol. 81, No. 166 / Friday, August 26, 2016 / Rules and Regulations letter dated June 20, 2016, the DEA received notification from the HHS that the FDA had granted the request on June 16, 2016, for Thianil (thiafentanil oxalate) to be added to the Index. Pursuant to 21 U.S.C. 811(j), and based on the HHS recommendation, MUMS Act indication by the HHS/FDA, and the DEA’s determination, the DEA finds that thiafentanil has a high potential for abuse, a currently accepted medical use with severe restrictions, and that abuse of thiafentanil may lead to severe psychological or physical dependence. Accordingly, the DEA is issuing this interim final rule to add thiafentanil (4-(methoxycarbonyl)-4-(Nphenylmethoxyacetamido)-1-[2-(2thienyl)ethyl]piperidine) and its isomers, esters, ethers, salts and salts of isomers, esters and ethers, whenever the existence of such, to schedule II of the CSA. Included below is a brief summary of each factor as analyzed by the HHS and the DEA, and as considered by the DEA in its scheduling action. Please note that the DEA and HHS analyses, along with the HHS supplement, are available in their entirety under ‘‘Supporting Documents’’ in the public docket for this interim final rule at http:// www.regulations.gov, under Docket Number ‘‘DEA–375.’’ Full analysis of, and citations to, the information referenced in the summary may also be found in the supporting and related material. 1. The Drug’s Actual or Relative Potential for Abuse: Thiafentanil is a chemical substance that has not been marketed in the United States, however, it is approved and marketed in the Republic of South Africa as a salt form under the brand name Thianil (thiafentanil oxalate). There is no information available which details actual abuse of thiafentanil. According to the HHS, thiafentanil is a synthetic analogue of fentanyl and is structurally related to other fentanyllike opioids such as sufentanil (schedule II) and carfentanil (schedule II). It acts as a potent m-opioid receptor agonist and produces strong morphinelike effects in animals. It is only intended for the immobilization of nondomestic, non-food-producing minor species hoofstock. Thiafentanil has been used in a manner similar to other opioid immobilizing agents such as etorphine hydrochloride (schedule II) and carfentanil (schedule II), which are approved only for veterinary use as animal immobilization agents. The abuse potential of thiafentanil has not been evaluated in humans or in animal behavioral models that are predictors of abuse by humans. Because thiafentanil VerDate Sep<11>2014 14:39 Aug 25, 2016 Jkt 238001 shares chemical and pharmacological similarities with schedule II fentanyl and its analogues, the abuse potential of thiafentanil is considered similar to that of schedule II opioid substances such as sufentanil and carfentanil. Pharmacologically, as a potent m opioid receptor agonist, thiafentanil is slightly less potent than carfentanil, which is 100 times more potent than fentanyl and 10,000 times more potent than morphine. Thiafentanil is a potent fentanyl analogue. Thus, it is reasonable to assume that there will be potentially significant diversion of thiafentanil from legitimate channels by people who have access to it, and that thiafentanil would be used without medical advice, therefore causing substantial hazards to the users or to the safety of the community if not controlled. The chemical and potent opioid-like pharmacological properties of thiafentanil predict that its risk to the public health is likely to be similar to fentanyl (schedule II) and its analogues such as carfentanil (schedule II), sufentanil (schedule II) and alphamethylfentanyl (schedule I). 2. Scientific Evidence of the Drug’s Pharmacological Effects, if Known: According to HHS’ scientific and medical review, there are no data on the effects of thiafentanil in humans. Thiafentanil’s effects in humans are predicted from its effects in animals and its chemical and pharmacological similarity to other schedule II potent opioids such as fentanyl and carfentanil. The HHS eight-factor review document described a study directly comparing the immobilizing effects of thiafentanil (15 mg) and carfentanil (2 or 4 mg) in elk in which thiafentanil produced a faster immobilization effect (0.7 to 2.2 minutes) than carfentanil. In addition, the elk returned to standing 0.9 to 1.4 minutes faster under the thiafentanil condition. This study appears to support a faster immobilization and recovery time with thiafentanil relative to carfentanil. However, the authors stated that the role of the increased dose of thiafentanil is unknown. Animal studies described by the HHS demonstrated that the effects of thiafentanil and carfentanil are completely reversed by naltrexone. As a m-opioid receptor antagonist, naltrexone can reverse the effects of a variety of opioid drugs including thiafentanil and carfentanil. Those studies suggest that thiafentanil possesses a neuropharmacological mechanism of action similar to other schedule II opioid drugs with a high abuse potential. According to HHS’ review, Thianil (thiafentanil) is currently approved and PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 registered for use in the Republic of South Africa. Thiafentanil oxalate is suggested as a drug of choice in the capture of exotic and ungulate wildlife species. 3. The State of Current Scientific Knowledge Regarding Thiafentanil: The chemical name of free base thiafentanil is 4-(methoxycarbonyl)-4-(Nphenylmethoxyacetamido)-1-[2-(2thienyl)ethyl]piperidine. It has a molecular formula of C22H28N2O4S and a molecular weight of 416.52 g/mol with a Chemical Abstract Registry Number (CAS) of 101345–60–2. Thiafentanil oxalate is also known as A3080 with a CAS number of 101365–73–5 and has a molecular formula of C24H30N2O8S with a molecular weight of 506.57 g/mol. Thiafentanil oxalate is a white crystalline powder with a melting point of 190–192 °C and its salt crystalizes from absolute alcohol. Thiafentanil should not be confused with thiofentanyl (N-phenyl-N-(1-(2(thiophen-2-yl)ethyl)piperidin-4yl)propionamide), which is currently listed as a schedule I substance. 4. Its History and Current Pattern of Abuse: According to the HHS’ review, there are no reports of actual abuse and misuse of thiafentanil. This may be due to the limited use of thiafentanil as an immobilizing agent by trained veterinarians. Current data from the National Forensic Laboratory System (NFLIS),1 the System to Retrieve Information from Drug Evidence (STRIDE),2 and the STARLiMS databases show that there is no evidence of law enforcement encounters of thiafentanil in the United States. However, thiafentanil’s pharmacological and structural properties suggest that its pattern of abuse would be similar to other potent 1 The National Forensic Laboratory System (NFLIS) is a program of the DEA, Office of Diversion Control. NFLIS systematically collects drug identification results and associated information from drug cases submitted to and analyzed by State and local forensic laboratories. NFLIS represents an important resource in monitoring illicit drug abuse and trafficking, including the diversion of legally manufactured pharmaceuticals into illegal markets. NFLIS is a comprehensive information system that includes data from forensic laboratories that handle approximately 90% of an estimated 1.0 million distinct annual State and local drug analysis cases. NFLIS includes drug chemistry results from completed analyses only. While NFLIS data is not direct evidence of abuse, it can lead to an inference that a drug has been diverted and abused. See 76 FR 77330, 77332, Dec. 12, 2011. 2 The System to Retrieve Information from Drug Evidence (STRIDE) is a database of drug exhibits sent to DEA laboratories for analysis. Exhibits from the database are from the DEA, other federal agencies, and local law enforcement agencies. Reporting via STRIDE ceased on September 30, 2014. STRIDE was succeeded by STARLiMS. E:\FR\FM\26AUR1.SGM 26AUR1 ehiers on DSK5VPTVN1PROD with RULES Federal Register / Vol. 81, No. 166 / Friday, August 26, 2016 / Rules and Regulations schedule II m-opioid receptor agonists such as fentanyl and carfentanil. 5. The Scope, Duration, and Significance of Abuse: An assessment of the scope, duration, and significance of thiafentanil abuse is not available since it has only been used in a limited market. However, as stated in the HHS review, the structural and pharmacological properties of thiafentanil suggest that it could lead to an abuse pattern with a scope, duration, and significance of abuse similar to that observed with other opioid drugs and opioid analogues if it were marketed in a non-controlled status or were the subject of clandestine synthesis. The HHS and DEA note that thiafentanil is not known to be or to have been the subject of abuse in the United States. 6. What, if any, Risk There is to the Public Health: The HHS review indicates that thiafentanil presents a significant risk to the public health and, in this vein, that thiafentanil should only be used in certain animals for very limited purposes and with extreme caution. Based on the review of the structural and pharmacological properties of thiafentanil, the HHS concluded that the abuse of thiafentanil is likely to pose a similar risk to public health as that of other potent opioid drugs such as sufentanil (schedule II), fentanyl (schedule II), carfentanil (schedule II) and clandestinely synthesized alpha-methylfentanyl (schedule I). Thus, inappropriate use of thiafentanil poses a high risk to the public health. Among other things, HHS noted that as a fentanyl derivative, and assuming that thiafentanil can be aerosolized, the use of thiafentanil presents a significant risk to the public health. HHS described that thiafentanil’s labeling indicates that it is solely intended for use by zoologic, wildlife, or exotic animal veterinarians or field biologists who have received training and are supervised by veterinarians. The sponsor recommends the use of handling protocols similar to those in place for other scheduled potent opioids such as carfentanil. HHS further indicated that thiafentanil should be handled in teams consisting of at least two individuals knowledgeable about the hazards of working with potent mopioid agonist substances. Personal protective equipment such as latex gloves and protective eyewear should be used and syringes must be disposed of properly. If exposure to thiafentanil occurs in a remote or distant environment, veterinary naltrexone is recommended for use as a reversal agent. The label information will further state that thiafentanil must never be VerDate Sep<11>2014 14:39 Aug 25, 2016 Jkt 238001 used unless an adequate amount of reversal agent (naltrexone hydrochloride) is immediately available. HHS also describes the risk of thiafentanil intoxication upon ingestion of animals immobilized with thiafentanil. The label information states that thiafentanil is not intended for human or animal consumption or in non-food producing minor species that become eligible for consumption by humans or food-producing animals. Because thiafentanil, similar to carfentanil, etorphine hydrochloride and diprenorphine, is a potent m-opioid receptor agonist, it will be subject to specialized handling, distribution and storage procedures similar to those applicable for carfentanil, etorphine hydrochloride and diprenorphine as set forth in 21 CFR parts 1301 and 1305. As a result, this interim final rule revises 21 CFR 1301.74(g), 1301.75(e), 1305.07 introductory text and paragraph (a), and 1305.17(d) to include ‘‘thiafentanil.’’ 7. Its Psychic or Physiological Dependence Liability: HHS’ review states that the structural and pharmacological properties of thiafentanil suggest that it possesses a psychic and physiological dependence liability that is similar to other schedule II related m-opioid receptor agonist drugs such as sufentanil, fentanyl and carfentanil. As cited by the HHS review, a doubleblind abuse liability study examining intravenous fentanyl, buprenorphine, heroin, morphine, and oxycodone in methadone-maintained patients reported that fentanyl produced subjective effects similar to heroin (schedule I) on several outcome measures indicating that the two drugs produce similar subjective effects. It also demonstrates the psychic dependence liability of fentanyl, and thiafentanil is expected to produce effects similar to fentanyl and to present a similar risk of psychic and physiological dependence. There has been a major increase in abuse of opioids analgesics in the United States (HHS review document, 2011; Compton and Volkow, 2006). Thiafentanil, similar to these opioid analgesics, presents a risk of severe psychic and physiological dependence. 8. Whether the Substance is an Immediate Precursor of a Substance Already Controlled under the CSA: Thiafentanil is not considered an immediate precursor of any controlled substance. Determination of Appropriate Schedule The CSA lists the findings required to place a drug or other substance in any particular schedule (I, II, III, IV, or V). PO 00000 Frm 00029 Fmt 4700 Sfmt 4700 58837 21 U.S.C. 812(b). After consideration of the analysis and recommendation of the Assistant Secretary for Health of the HHS and review of all available data, the Acting Administrator of the DEA, pursuant to 21 U.S.C. 812(b)(2), finds that: 1. Thiafentanil has a high potential for abuse. Based on its structural and pharmacological properties, thiafentanil has an abuse potential that is comparable to other schedule II opioid drugs such as fentanyl, carfentanil, and sufentanil; 2. FDA determined that Thianil (thiafentanil oxalate) meets the requirements for addition to the Index as set forth by the MUMS Act, 2004 and accordingly added Thianil (thiafentanil oxalate) to the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (the Index) under section 572 of the Federal Food, Drug, and Cosmetic Act. Thianil (thiafentanil oxalate) will be legally marketed in the United States and will have an accepted medical use with severe restrictions; 3 and 3. Due to the chemical and pharmacological similarities of thiafentanil to other schedule II fentanyl derivatives, abuse of thiafentanil may lead to severe psychological or physical dependence. Based on these findings, the Acting Administrator of the DEA concludes that thiafentanil, including its isomers, esters, ethers, salts and salts of isomers, esters and ethers whenever the existences of such isomers, esters, ethers, and salts is possible warrants control in schedule II of the CSA. 21 U.S.C. 812(b)(2). Requirements for Handling Thiafentanil Thiafentanil is subject to the CSA’s schedule II regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, dispensing, importing, exporting, research, and conduct of instructional 3 According to the HHS analysis, ‘‘[u]se of a new animal indexed drug is subject to significant restrictions. For example, use of an indexed new animal drug for minor species is limited to a minor species for which there is a reasonable certainty that the animal or edible products from the animal will not be consumed by humans or food producing animals. 21 U.S.C. § 360ccc–l(a)(1). The requester must label, distribute, and promote the new animal drug in accordance with the Index entry, and the FDA may remove a new animal drug from the Index if the conditions and limitations of use have not been followed. 21 U.S.C. 360ccc–l(d)(l)(G); (f)(l)(F). The labeling of an indexed new animal drug must prominently state that the extra-label use of the product is prohibited. 21 U.S.C. 360ccc–l(h). Such restrictions are not imposed upon approved human or animal drugs.’’ E:\FR\FM\26AUR1.SGM 26AUR1 ehiers on DSK5VPTVN1PROD with RULES 58838 Federal Register / Vol. 81, No. 166 / Friday, August 26, 2016 / Rules and Regulations activities and chemical analysis with, and possession involving schedule II substances, including the following: 1. Registration. Any person who desires to handle thiafentanil (manufacture, distribute, reverse distribute, dispense, import, export, engage in research, or conduct instructional activities or chemical analysis with, or possess), must be registered with the DEA to conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958 and in accordance with 21 CFR parts 1301 and 1312. 2. Quota. Only registered manufacturers are permitted to manufacture thiafentanil in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303. 3. Disposal of stocks. Upon obtaining a schedule II registration to handle thiafentanil, and if subsequently, any person who does not desire or is not able to maintain a schedule II registration must surrender all quantities of currently held thiafentanil, or may transfer all quantities of currently held thiafentanil to a person registered with the DEA in accordance with 21 CFR part 1317, in addition to all other applicable federal, state, local, and tribal laws. 4. Security. Thiafentanil is subject to schedule II security requirements and must be handled and stored pursuant to 21 U.S.C. 821 and 823, and in accordance with 21 CFR 1301.71– 1301.93. 5. Labeling and Packaging. All labels, labeling, and packaging for commercial containers of thiafentanil must comply with 21 U.S.C. 825 and 958(e), and be in accordance with 21 CFR part 1302. In addition, thiafentanil is subject to additional labeling requirements provided by FDA. Thiafentanil must be labeled, distributed, and promoted in accordance with the Index entry of the new animal drug and the FDA may remove a new animal drug from the Index if the conditions and limitations of use have not been followed. 21 U.S.C. 360ccc–l(d)(l)(G); (f)(l)(F). The labeling of an indexed new animal drug must prominently state that the extra-label use of the product is prohibited. 21 U.S.C. 360ccc–l(h). 6. Inventory. Every DEA registrant who desires to possess any quantity of thiafentanil must take an inventory of thiafentanil on hand, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. Any person who becomes registered with the DEA to handle thiafentanil must take an initial inventory of all stocks of controlled substances VerDate Sep<11>2014 14:39 Aug 25, 2016 Jkt 238001 (including thiafentanil) on hand on the date the registrant first engages in the handling of controlled substances, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. After the initial inventory, every DEA registrant must take a new inventory of all stocks of controlled substances (including thiafentanil) on hand every two years, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. 7. Records and Reports. Every DEA registrant must maintain records and submit reports for thiafentanil, or products containing thiafentanil, pursuant to 21 U.S.C. 827 and 958(e), and in accordance with 21 CFR parts 1304, 1312, and 1317. 8. Orders for thiafentanil. Every DEA registrant who distributes thiafentanil is required to comply with order form requirements, pursuant to 21 U.S.C. 828, and in accordance with 21 CFR part 1305. 9. Prescriptions and other dispensing. All prescriptions for thiafentanil or products containing thiafentanil must comply with 21 U.S.C. 829, and be issued in accordance with 21 CFR parts 1306 and 1311, subpart C. Moreover, given that thiafentanil is not the subject of an approved new drug application under the FDCA, and that it is only allowed under the MUMS Act amendments to the FDCA to be marketed for extremely limited use in minor species, DEA would not consider any dispensing of thiafentanil for human use to be for a legitimate medical purpose within the meaning of the CSA. Likewise, DEA would not consider any dispensing of thiafentanil for animal use beyond the scope of the drug’s labeling authorized under the MUMS Act amendments to the FDCA to be for a legitimate medical purpose within the meaning of the CSA. 10. Manufacturing and Distributing. In addition to the general requirements of the CSA and DEA regulations that are applicable to manufacturers and distributors of schedule II controlled substances, such registrants should be advised that (consistent with the foregoing considerations) any manufacturing or distribution of thiafentanil may only be for the legitimate purposes consistent with the drug’s labeling authorized under the MUMS Act, or for research activities authorized by the FDCA and CSA. 11. Importation and Exportation. All importation and exportation of thiafentanil must be in compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance with 21 CFR part 1312. PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 12. Liability. Any activity involving thiafentanil not authorized by, or in violation of, the CSA or its implementing regulations, is unlawful, and may subject the person to administrative, civil, and/or criminal sanctions. Regulatory Analyses Administrative Procedure Act Public Law 114–89 was signed into law, amending 21 U.S.C. 811. This amendment provides that in cases where a new drug is (1) approved or indexed by the Department of Health and Human Services (HHS) and (2) HHS recommends control in CSA schedule II–V, the DEA shall issue an interim final rule scheduling the drug within 90 days. Additionally, the law specifies that the rulemaking shall become immediately effective as an interim final rule without requiring the DEA to demonstrate good cause. Therefore, the DEA has determined that the notice and comment requirements of section 553 of the APA, 5 U.S.C. 553, do not apply to this scheduling action. Executive Orders 12866, Regulatory Planning and Review, and 13563, Improving Regulation and Regulatory Review In accordance with Public Law 114– 89, this scheduling action is subject to formal rulemaking procedures performed ‘‘on the record after opportunity for a hearing,’’ which are conducted pursuant to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the procedures and criteria for scheduling a drug or other substance. Such actions are exempt from review by the Office of Management and Budget (OMB) pursuant to section 3(d)(1) of Executive Order 12866 and the principles reaffirmed in Executive Order 13563. Executive Order 12988, Civil Justice Reform This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction. Executive Order 13132, Federalism This rulemaking does not have federalism implications warranting the application of Executive Order 13132. The rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and E:\FR\FM\26AUR1.SGM 26AUR1 Federal Register / Vol. 81, No. 166 / Friday, August 26, 2016 / Rules and Regulations responsibilities among the various levels of government. Executive Order 13175, Consultation and Coordination With Indian Tribal Governments This rule does not have tribal implications warranting the application of Executive Order 13175. It does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes. Regulatory Flexibility Act In accordance with 5 U.S.C. 603(a), ‘‘[w]henever an agency is required by [5 U.S.C. 553], or any other law, to publish general notice of proposed rulemaking for any proposed rule, or publishes a notice of proposed rulemaking for an interpretive rule involving the internal revenue laws of the United States, the agency shall prepare and make available for public comment an initial regulatory flexibility analysis.’’ As noted in the above discussion regarding applicability of the Administrative Procedure Act, the DEA has determined that the notice and comment requirements of section 553 of the APA, 5 U.S.C. 553, do not apply to this scheduling action. Consequently, the RFA does not apply to this interim final rule. ehiers on DSK5VPTVN1PROD with RULES Unfunded Mandates Reform Act of 1995 In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1501 et seq., the DEA has determined and certifies that this action would not result in any Federal mandate that may result ‘‘in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted for inflation) in any one year.’’ Therefore, neither a Small Government Agency Plan nor any other action is required under UMRA of 1995. Paperwork Reduction Act of 1995 This action does not impose a new collection of information requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501–3521. This action would not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Congressional Review Act This rule is not a major rule as defined by section 804 of the Small VerDate Sep<11>2014 14:39 Aug 25, 2016 Jkt 238001 58839 Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act (CRA)). This rule will not result in: An annual effect on the economy of $100,000,000 or more; a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of U.S.-based companies to compete with foreign based companies in domestic and export markets. However, pursuant to the CRA, the DEA has submitted a copy of this interim final rule to both Houses of Congress and to the Comptroller General. § 1301.75 Physical security controls for practitioners. List of Subjects § 1305.07 Special procedure for filling certain orders. 21 CFR Part 1301 Administrative practice and procedure, Drug traffic control, Security measures. 21 CFR Part 1305 Drug traffic control, Reporting and recordkeeping requirements. 21 CFR Part 1308 Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements. For the reasons set out above, the DEA amends 21 CFR parts 1301, 1305 and 1308 as follows: PART 1301—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES 1. The authority citation for 21 CFR part 1301 continues to read as follows: ■ Authority: 21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877, 886a, 951, 952, 953, 956, 957, 958, 965. 2. In § 1301.74, revise paragraph (g) to read as follows: ■ § 1301.74 Other security controls for nonpractitioners; narcotic treatment programs and compounders for narcotic treatment programs. * * * * * (g) Before the initial distribution of thiafentanil, carfentanil, etorphine hydrochloride and/or diprenorphine to any person, the registrant must verify that the person is authorized to handle the substance(s) by contacting the Drug Enforcement Administration. * * * * * ■ 3. In § 1301.75, revise paragraph (e) to read as follows: PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 * * * * * (e) Thiafentanil, carfentanil, etorphine hydrochloride and diprenorphine shall be stored in a safe or steel cabinet equivalent to a U.S. Government Class V security container. PART 1305—ORDERS FOR SCHEDULE I AND II CONTROLLED SUBSTANCES 4. The authority citation for 21 CFR part 1305 continues to read as follows: ■ Authority: 21 U.S.C. 821, 828, 871(b), unless otherwise noted. 5. In § 1305.07, revise the introductory text and paragraph (a) to read as follows: ■ A supplier of thiafentanil, carfentanil, etorphine hydrochloride, or diprenorphine, if he or she determines that the purchaser is a veterinarian engaged in zoo and exotic animal practice, wildlife management programs, or research, and is authorized by the Administrator to handle these substances, may fill the order in accordance with the procedures set forth in § 1305.17 except that: (a) A DEA Form 222 or an electronic order for thiafentanil, carfentanil, etorphine hydrochloride, and diprenorphine must contain only these substances in reasonable quantities. * * * * * 6. In § 1305.17, revise paragraph (d) to read as follows: ■ § 1305.17 Preservation of DEA Forms 222. * * * * * (d) The supplier of thiafentanil, carfentanil, etorphine hydrochloride, and diprenorphine must maintain DEA Forms 222 for these substances separately from all other DEA Forms 222 and records required to be maintained by the registrant. PART 1308—SCHEDULES OF CONTROLLED SUBSTANCES 7. The authority citation for 21 CFR part 1308 continues to read as follows: ■ Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted. 8. In § 1308.12, add paragraph (c)(29) to read as follows: ■ § 1308.12 * Schedule II. * * (c) * * * * * (29) Thiafentanil ................................ * E:\FR\FM\26AUR1.SGM * * 26AUR1 * * 9729 58840 Federal Register / Vol. 81, No. 166 / Friday, August 26, 2016 / Rules and Regulations Dated: August 18, 2016. Chuck Rosenberg, Acting Administrator. [FR Doc. 2016–20463 Filed 8–25–16; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF DEFENSE Office of the Secretary 32 CFR Part 232 [Docket ID: DOD–2013–OS–0133] RIN 0790–ZA11 Military Lending Act Limitations on Terms of Consumer Credit Extended to Service Members and Dependents Under Secretary of Defense for Personnel and Readiness, Department of Defense. ACTION: Interpretive rule. AGENCY: The Department of Defense (Department) is interpreting its regulation implementing the Military Lending Act (the MLA). The MLA as implemented by the Department, limits the military annual percentage rate (MAPR) that a creditor may charge to a maximum of 36 percent, requires certain disclosures, and provides other substantive consumer protections on ‘‘consumer credit’’ extended to Service members and their families. On July 22, 2015, the Department amended its regulation primarily for the purpose of extending the protections of the MLA to a broader range of closed-end and openend credit products (the July 2015 Final Rule). This interpretive rule provides guidance on certain questions the Department has received regarding compliance with the July 2015 Final Rule. DATES: Effective Date: August 26, 2016. FOR FURTHER INFORMATION CONTACT: Marcus Beauregard, 571–372–5357. SUPPLEMENTARY INFORMATION: ehiers on DSK5VPTVN1PROD with RULES SUMMARY: I. Background and Purpose In July, 2015, the Department of Defense (Department) issued a final rule 1 (the July 2015 Final Rule) amending its regulation implementing the Military Lending Act (MLA) 2 primarily for the purpose of extending the protections of the MLA to a broader range of closed-end and open-end credit products, rather than the limited credit products that had been defined as ‘‘consumer credit.’’ 3 Moreover, among 1 80 FR 435560. 2 10 U.S.C. 987. 3 32 CFR 232.3(b) as implemented in a final rule published at 72 FR 50580 (Aug. 31, 2007). VerDate Sep<11>2014 14:39 Aug 25, 2016 Jkt 238001 other amendments, the July 2015 Final Rule modified provisions relating to the optional mechanism a creditor may use when assessing whether a consumer is a ‘‘covered borrower,’’ modified the disclosures that a creditor must provide to a covered borrower, and implemented the enforcement provisions of the MLA. Subsequently, the Department received requests to clarify its interpretation of points raised in the July 2015 Final Rule. The Department is issuing this interpretive rule to inform the public of its views. The Department has chosen to provide this guidance in the form of a question and answer document to assist industry in complying with the July 2015 Final Rule. This interpretive rule does not substantively change the regulation implementing the MLA, but rather merely states the Department’s preexisting interpretations of an existing regulation. Therefore, under 5 U.S.C. 553(b)(A), this rulemaking is exempt from the notice and comment requirements of the Administrative Procedure Act, and, pursuant to 5 U.S.C. 553(d)(2), this rule is effective immediately upon publication in the Federal Register. II. Interpretations of the Department The following questions and answers represent official interpretations of the Department on issues related to 32 CFR part 232. For ease of reference, the following terms are used throughout this document: MLA refers to the Military Lending Act (codified at 10 U.S.C. 987); MAPR refers to the military annual percentage rate, as defined in 32 CFR 232.3(p); TILA refers to the Truth in Lending Act (codified at 15 U.S.C. 1601 et seq.); Regulation Z refers to the regulation, and interpretations thereof, issued by the Consumer Financial Protection Bureau (or the Board of Governors of the Federal Reserve System, as applicable) to implement TILA, as defined in 32 CFR 232.3(s); DMDC refers to the Defense Manpower Data Center. 1. What types of overdraft products are within the scope of 32 CFR 232.3(f) defining ‘‘consumer credit’’? Answer: The MLA regulation generally directs creditors to look to provisions of TILA and its implementing regulation, Regulation Z, in determining whether a product or service is considered ‘‘consumer credit’’ for purposes of the MLA.4 Also, the 4 The Department notes that the Consumer Financial Protection Bureau may from time to time revise Regulation Z. See, e.g., 79 FR 77102 (Dec. 23, 2014) (proposing to revise the definition of finance charge with respect to charges imposed in PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 supplementary information to the July 2015 Final Rule discusses coverage of overdraft products. The MLA regulation defines ‘‘consumer credit’’ as credit offered or extended to a covered borrower primarily for personal, family or household purposes that is either subject to a finance charge or payable by a written agreement in more than four installments, with some exceptions. The exceptions include: Residential mortgage transactions; purchase money credit for a vehicle or personal property that is secured by the purchased vehicle or personal property; certain transactions exempt from Regulation Z (not including transactions exempt under 12 CFR 1026.29); and credit extended to non-covered borrowers consistent with 32 CFR 232.5(b). Although coverage by the MLA and the MLA regulation is not completely identical to that of TILA and Regulation Z, the July 2015 Final Rule amends the definition of consumer credit under the MLA to be more consistent with how credit is defined under TILA. The supplementary information to the July 2015 Final Rule states: As proposed, the Department is amending its regulation so that, in general, consumer credit covered under the MLA would be defined consistently with credit that for decades has been subject to TILA, namely: Credit offered or extended to a covered borrower primarily for personal, family, or household purposes, and that is (i) subject to a finance charge or (ii) payable by a written agreement in more than four installments.5 The MLA regulation also defines ‘‘closed-end credit’’ and ‘‘open-end credit’’ with express references to the definitions of the same terms in Regulation Z. The supplementary information to the July 2015 Final Rule illustrates how to apply these standards specifically with respect to overdraft products and services.6 It states that consistent with Regulation Z, an overdraft line of credit with a finance charge is a covered consumer credit product when: It is offered to a covered borrower; the credit extended by the creditor is primarily for personal, family, or household purposes; it is used to pay an item that overdraws an asset account and results in a fee or charge to the covered borrower; and, the extension of credit connection with certain credit features offered in conjunction with prepaid card accounts). It is the Department’s intention that this part should wherever possible be interpreted consistently with Regulation Z as it evolves in order to harmonize the two regulations and thereby minimize compliance burden. 5 80 FR 43563 (footnotes omitted). 6 80 FR 43579–43580. E:\FR\FM\26AUR1.SGM 26AUR1

Agencies

[Federal Register Volume 81, Number 166 (Friday, August 26, 2016)]
[Rules and Regulations]
[Pages 58834-58840]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-20463]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1301, 1305, and 1308

[Docket No. DEA-375]


Schedules of Controlled Substances: Placement of Thiafentanil 
Into Schedule II

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Interim final rule with request for comments.

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

SUMMARY: The Drug Enforcement Administration is placing the substance 
thiafentanil (4-(methoxycarbonyl)-4-(N-phenmethoxyacetamido)-1-[2-
(thienyl)ethyl]piperidine), including its isomers, esters, ethers, 
salts and salts of isomers, esters and ethers as possible, into 
schedule II of the Controlled Substances Act. This scheduling action is 
pursuant to the Controlled Substances Act, as revised by the Improving 
Regulatory Transparency for New Medical Therapies Act which was signed 
into law on November 25, 2015.

DATES: The effective date of this rule is August 26, 2016. Interested 
persons may file written comments on this rule in accordance with 21 
U.S.C. 811(j)(3) and 21 CFR 1308.43(g). Electronic comments must be 
submitted, and written comments must be postmarked, on or before 
September 26, 2016. Commenters should be aware that the electronic 
Federal Docket Management System will not accept comments after 11:59 
p.m. Eastern Time on the last day of the comment period.
    Interested persons, defined at 21 CFR 1300.01 as those ``adversely 
affected or aggrieved by any rule or proposed rule issuable pursuant to 
section 201 of the Act (21 U.S.C. 811),'' may file a request for 
hearing or waiver of hearing pursuant to 21 CFR 1308.44 and in 
accordance with 21 CFR 1316.45 and/or 1316.47, as applicable. Requests 
for hearing and waivers of an opportunity for a hearing or to 
participate in a hearing must be received on or before September 26, 
2016.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-375'' on all correspondence, including any 
attachments.
     Electronic comments: The Drug Enforcement Administration 
encourages that all comments be submitted electronically through the 
Federal eRulemaking Portal, which provides the ability to type short 
comments directly into the comment field on the Web page or attach a 
file for lengthier comments. Please go to http://www.regulations.gov 
and follow the online instructions at that site for submitting 
comments. Upon completion of your submission, you will receive a 
Comment Tracking Number for your comment. Please be aware that 
submitted comments are not instantaneously available for public view on 
Regulations.gov. If you have received a Comment Tracking Number, your 
comment has been successfully submitted and there is no need to 
resubmit the same comment.
     Paper comments: Paper comments that duplicate the 
electronic submission are not necessary and are discouraged. Should you 
wish to mail a paper comment in lieu of an electronic comment, it 
should be sent via regular or express mail to: Drug Enforcement 
Administration, Attn: DEA Federal Register Representative/ODW, 8701 
Morrissette Drive, Springfield, Virginia 22152.
     Hearing requests: All requests for hearing and waivers of 
participation must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests for hearing and waivers of participation should also be sent 
to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 
Morrissette Drive, Springfield, Virginia 22152; and (2) Drug 
Enforcement Administration, Attn: DEA Federal Register Representative/
ODW, 8701 Morrissette Drive, Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Office of Diversion 
Control, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-
6812.

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

    Please note that all comments received are considered part of the 
public record. They will, unless reasonable cause is given, be made 
available by the Drug Enforcement

[[Page 58835]]

Administration (DEA) for public inspection online at http://www.regulations.gov. Such information includes personal identifying 
information (such as your name, address, etc.) voluntarily submitted by 
the commenter. The Freedom of Information Act (FOIA) applies to all 
comments received. If you want to submit personal identifying 
information (such as your name, address, etc.) as part of your comment, 
but do not want it to be made publicly available, you must include the 
phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first paragraph of 
your comment. You must also place all of the personal identifying 
information you do not want made publicly available in the first 
paragraph of your comment and identify what information you want 
redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be made publicly available, you 
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the 
first paragraph of your comment. You must also prominently identify the 
confidential business information to be redacted within the comment.
    Comments containing personal identifying information and 
confidential business information identified as directed above will 
generally be made publicly available in redacted form. If a comment has 
so much confidential business information or personal identifying 
information that it cannot be effectively redacted, all or part of that 
comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information 
(such as name, address, and phone number) included in the text of your 
electronic submission that is not identified as directed above as 
confidential.
    An electronic copy of this document and supplemental information, 
including the complete Department of Health and Human Services and Drug 
Enforcement Administration eight-factor analyses, to this interim final 
rule are available at http://www.regulations.gov for easy reference.

Request for Hearing, Notice of Appearance at Hearing, or Waiver of 
Participation in Hearing

    Pursuant to 21 U.S.C. 811(a), this action is a formal rulemaking 
``on the record after opportunity for a hearing.'' Such proceedings are 
conducted pursuant to the provisions of the Administrative Procedure 
Act (APA), 5 U.S.C. 551-559. 21 CFR 1308.41-1308.45; 21 CFR part 1316, 
subpart D. In accordance with 21 CFR 1308.44(a)-(c), requests for a 
hearing, notices of appearance, and waivers of an opportunity for a 
hearing or to participate in a hearing may be submitted only by 
interested persons, defined as those ``adversely affected or aggrieved 
by any rule or proposed rule issuable pursuant to section 201 of the 
Act (21 U.S.C. 811).'' 21 CFR 1300.01. Requests for a hearing and 
notices of participation must conform to the requirements of 21 CFR 
1308.44(a) or (b), as applicable, and include a statement of the 
interest of the person in the proceeding and the objections or issues, 
if any, concerning which the person desires to be heard. Any waiver of 
an opportunity for a hearing must conform to the requirements of 21 CFR 
1308.44(c), including a written statement regarding the interested 
person's position on the matters of fact and law involved in any 
hearing.
    Please note that pursuant to 21 U.S.C. 811(a), the purpose and 
subject matter of the hearing are restricted to ``(A) find[ing] that 
such drug or other substance has a potential for abuse, and (B) 
mak[ing] with respect to such drug or other substance the findings 
prescribed by subsection (b) of section 812 of this title for the 
schedule in which such drug is to be placed . . . .'' Requests for a 
hearing and waivers of participation in the hearing should be submitted 
to the DEA on or before the deadline specified above, using the address 
information provided therein.

Background, Legal Authority, and Basis for This Scheduling Action

    Thiafentanil, known chemically as 4-(methoxycarbonyl)-4-(N-
phenylmethoxyacetamido)-1-[2-(2-thienyl)ethyl]piperidine, a potent 
opioid, is an analogue of fentanyl. The product Thianil (thiafentanil 
oxalate, a salt form of thiafentanil) was reviewed by the Food and Drug 
Administration (FDA) to determine whether it meets the requirements for 
addition to the Index of Legally Marketed Unapproved New Animal Drugs 
for Minor Species (the Index) (21 U.S.C. 360ccc-1) as set forth by the 
Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act, 2004). 
The MUMS Act amended the Federal Food, Drug, and Cosmetic Act (FDCA) to 
allow for the legal marketing of unapproved new animal drugs intended 
for use in minor species. In a letter from the Department of Health and 
Human Services (HHS) dated June 20, 2016, the DEA received notification 
that HHS/FDA added Thianil (thiafentanil oxalate) to the Index under 
section 572 of the FDCA. In this same notification, HHS/FDA stated that 
on June 16, 2016, HHS/FDA granted the request for the addition of 
Thianil to the Index under Minor Species Index File (MIF) 900000. 
Thianil is indicated for use in the immobilization of non-domestic, 
non-food-producing minor species hoofstock.
    Thiafentanil will be marketed as thiafentanil oxalate, 4-
(methoxycarbonyl)-4-(N-phenylmethoxyacetamido)-1-[2-(2-
thienyl)ethyl]piperidinium oxalate. Thiafentanil should not be confused 
with thiofentanyl (N-phenyl-N-(1-(2-(thiophen-2-yl)ethyl)piperidin-4-
yl)propionamide), which is currently listed as a controlled schedule I 
substance.
    Under the Controlled Substances Act (CSA), as amended in 2015 by 
the Improving Regulatory Transparency for New Medical Therapies Act 
(Pub. L. 114-89), where the DEA receives notification from HHS that the 
Secretary has indexed a drug under section 572 of the FDCA, the DEA is 
required to issue an interim final rule controlling the drug not later 
than 90 days after receiving such notification from HHS. 21 U.S.C. 
811(j). Accordingly, the DEA is issuing this interim final rule 
controlling thiafentanil.
    When controlling a drug pursuant to section 811(j), the DEA must 
apply the scheduling criteria of subsections 811(b), (c), and (d) and 
section 812(b). 21 U.S.C. 811(j)(3). In accordance with these criteria, 
the DEA has reviewed the scientific and medical evaluation and 
scheduling recommendation provided by the HHS, along with all other 
relevant data, and completed its own eight-factor review document on 
thiafentanil pursuant to 21 U.S.C. 811(c). As explained below, based on 
these considerations, the DEA concludes that thiafentanil meets the 
criteria for placement in schedule II of the CSA.
    On November 28, 2011, the HHS provided the DEA with its initial 
scientific and medical evaluation and scheduling recommendation 
regarding thiafentanil. Pursuant to 21 U.S.C. 811(b), this document 
contained an eight-factor analysis of the abuse potential of 
thiafentanil as a new drug, along with the HHS' recommendation to 
control thiafentanil and its salts under schedule II of the CSA. 
Subsequently, on March 23, 2016, the HHS provided the DEA with a 
supplement to its 2011 analysis, which indicated that the HHS/FDA 
planned to add Thianil (thiafentanil oxalate) to the Index for use in 
the immobilization of non-domestic, non-food-producing minor species 
hoofstock and reiterated their recommendation that thiafentanil be 
placed in schedule II of the CSA. By

[[Page 58836]]

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

[[Page 58837]]

schedule II [micro]-opioid receptor agonists such as fentanyl and 
carfentanil.
---------------------------------------------------------------------------

    \1\ The National Forensic Laboratory System (NFLIS) is a program 
of the DEA, Office of Diversion Control. NFLIS systematically 
collects drug identification results and associated information from 
drug cases submitted to and analyzed by State and local forensic 
laboratories. NFLIS represents an important resource in monitoring 
illicit drug abuse and trafficking, including the diversion of 
legally manufactured pharmaceuticals into illegal markets. NFLIS is 
a comprehensive information system that includes data from forensic 
laboratories that handle approximately 90% of an estimated 1.0 
million distinct annual State and local drug analysis cases. NFLIS 
includes drug chemistry results from completed analyses only. While 
NFLIS data is not direct evidence of abuse, it can lead to an 
inference that a drug has been diverted and abused. See 76 FR 77330, 
77332, Dec. 12, 2011.
    \2\ The System to Retrieve Information from Drug Evidence 
(STRIDE) is a database of drug exhibits sent to DEA laboratories for 
analysis. Exhibits from the database are from the DEA, other federal 
agencies, and local law enforcement agencies. Reporting via STRIDE 
ceased on September 30, 2014. STRIDE was succeeded by STARLiMS.
---------------------------------------------------------------------------

    5. The Scope, Duration, and Significance of Abuse: An assessment of 
the scope, duration, and significance of thiafentanil abuse is not 
available since it has only been used in a limited market. However, as 
stated in the HHS review, the structural and pharmacological properties 
of thiafentanil suggest that it could lead to an abuse pattern with a 
scope, duration, and significance of abuse similar to that observed 
with other opioid drugs and opioid analogues if it were marketed in a 
non-controlled status or were the subject of clandestine synthesis. The 
HHS and DEA note that thiafentanil is not known to be or to have been 
the subject of abuse in the United States.
    6. What, if any, Risk There is to the Public Health: The HHS review 
indicates that thiafentanil presents a significant risk to the public 
health and, in this vein, that thiafentanil should only be used in 
certain animals for very limited purposes and with extreme caution. 
Based on the review of the structural and pharmacological properties of 
thiafentanil, the HHS concluded that the abuse of thiafentanil is 
likely to pose a similar risk to public health as that of other potent 
opioid drugs such as sufentanil (schedule II), fentanyl (schedule II), 
carfentanil (schedule II) and clandestinely synthesized alpha-
methylfentanyl (schedule I). Thus, inappropriate use of thiafentanil 
poses a high risk to the public health. Among other things, HHS noted 
that as a fentanyl derivative, and assuming that thiafentanil can be 
aerosolized, the use of thiafentanil presents a significant risk to the 
public health.
    HHS described that thiafentanil's labeling indicates that it is 
solely intended for use by zoologic, wildlife, or exotic animal 
veterinarians or field biologists who have received training and are 
supervised by veterinarians. The sponsor recommends the use of handling 
protocols similar to those in place for other scheduled potent opioids 
such as carfentanil. HHS further indicated that thiafentanil should be 
handled in teams consisting of at least two individuals knowledgeable 
about the hazards of working with potent [mu]-opioid agonist 
substances. Personal protective equipment such as latex gloves and 
protective eyewear should be used and syringes must be disposed of 
properly. If exposure to thiafentanil occurs in a remote or distant 
environment, veterinary naltrexone is recommended for use as a reversal 
agent. The label information will further state that thiafentanil must 
never be used unless an adequate amount of reversal agent (naltrexone 
hydrochloride) is immediately available.
    HHS also describes the risk of thiafentanil intoxication upon 
ingestion of animals immobilized with thiafentanil. The label 
information states that thiafentanil is not intended for human or 
animal consumption or in non-food producing minor species that become 
eligible for consumption by humans or food-producing animals. Because 
thiafentanil, similar to carfentanil, etorphine hydrochloride and 
diprenorphine, is a potent [mu]-opioid receptor agonist, it will be 
subject to specialized handling, distribution and storage procedures 
similar to those applicable for carfentanil, etorphine hydrochloride 
and diprenorphine as set forth in 21 CFR parts 1301 and 1305. As a 
result, this interim final rule revises 21 CFR 1301.74(g), 1301.75(e), 
1305.07 introductory text and paragraph (a), and 1305.17(d) to include 
``thiafentanil.''
    7. Its Psychic or Physiological Dependence Liability: HHS' review 
states that the structural and pharmacological properties of 
thiafentanil suggest that it possesses a psychic and physiological 
dependence liability that is similar to other schedule II related 
[micro]-opioid receptor agonist drugs such as sufentanil, fentanyl and 
carfentanil.
    As cited by the HHS review, a double-blind abuse liability study 
examining intravenous fentanyl, buprenorphine, heroin, morphine, and 
oxycodone in methadone-maintained patients reported that fentanyl 
produced subjective effects similar to heroin (schedule I) on several 
outcome measures indicating that the two drugs produce similar 
subjective effects. It also demonstrates the psychic dependence 
liability of fentanyl, and thiafentanil is expected to produce effects 
similar to fentanyl and to present a similar risk of psychic and 
physiological dependence. There has been a major increase in abuse of 
opioids analgesics in the United States (HHS review document, 2011; 
Compton and Volkow, 2006). Thiafentanil, similar to these opioid 
analgesics, presents a risk of severe psychic and physiological 
dependence.
    8. Whether the Substance is an Immediate Precursor of a Substance 
Already Controlled under the CSA: Thiafentanil is not considered an 
immediate precursor of any controlled substance.

Determination of Appropriate Schedule

    The CSA lists the findings required to place a drug or other 
substance in any particular schedule (I, II, III, IV, or V). 21 U.S.C. 
812(b). After consideration of the analysis and recommendation of the 
Assistant Secretary for Health of the HHS and review of all available 
data, the Acting Administrator of the DEA, pursuant to 21 U.S.C. 
812(b)(2), finds that:
    1. Thiafentanil has a high potential for abuse. Based on its 
structural and pharmacological properties, thiafentanil has an abuse 
potential that is comparable to other schedule II opioid drugs such as 
fentanyl, carfentanil, and sufentanil;
    2. FDA determined that Thianil (thiafentanil oxalate) meets the 
requirements for addition to the Index as set forth by the MUMS Act, 
2004 and accordingly added Thianil (thiafentanil oxalate) to the Index 
of Legally Marketed Unapproved New Animal Drugs for Minor Species (the 
Index) under section 572 of the Federal Food, Drug, and Cosmetic Act. 
Thianil (thiafentanil oxalate) will be legally marketed in the United 
States and will have an accepted medical use with severe restrictions; 
\3\ and
---------------------------------------------------------------------------

    \3\ According to the HHS analysis, ``[u]se of a new animal 
indexed drug is subject to significant restrictions. For example, 
use of an indexed new animal drug for minor species is limited to a 
minor species for which there is a reasonable certainty that the 
animal or edible products from the animal will not be consumed by 
humans or food producing animals. 21 U.S.C. Sec.  360ccc-l(a)(1). 
The requester must label, distribute, and promote the new animal 
drug in accordance with the Index entry, and the FDA may remove a 
new animal drug from the Index if the conditions and limitations of 
use have not been followed. 21 U.S.C. 360ccc-l(d)(l)(G); (f)(l)(F). 
The labeling of an indexed new animal drug must prominently state 
that the extra-label use of the product is prohibited. 21 U.S.C. 
360ccc-l(h). Such restrictions are not imposed upon approved human 
or animal drugs.''
---------------------------------------------------------------------------

    3. Due to the chemical and pharmacological similarities of 
thiafentanil to other schedule II fentanyl derivatives, abuse of 
thiafentanil may lead to severe psychological or physical dependence.
    Based on these findings, the Acting Administrator of the DEA 
concludes that thiafentanil, including its isomers, esters, ethers, 
salts and salts of isomers, esters and ethers whenever the existences 
of such isomers, esters, ethers, and salts is possible warrants control 
in schedule II of the CSA. 21 U.S.C. 812(b)(2).

Requirements for Handling Thiafentanil

    Thiafentanil is subject to the CSA's schedule II regulatory 
controls and administrative, civil, and criminal sanctions applicable 
to the manufacture, distribution, reverse distribution, dispensing, 
importing, exporting, research, and conduct of instructional

[[Page 58838]]

activities and chemical analysis with, and possession involving 
schedule II substances, including the following:
    1. Registration. Any person who desires to handle thiafentanil 
(manufacture, distribute, reverse distribute, dispense, import, export, 
engage in research, or conduct instructional activities or chemical 
analysis with, or possess), must be registered with the DEA to conduct 
such activities pursuant to 21 U.S.C. 822, 823, 957, and 958 and in 
accordance with 21 CFR parts 1301 and 1312.
    2. Quota. Only registered manufacturers are permitted to 
manufacture thiafentanil in accordance with a quota assigned pursuant 
to 21 U.S.C. 826 and in accordance with 21 CFR part 1303.
    3. Disposal of stocks. Upon obtaining a schedule II registration to 
handle thiafentanil, and if subsequently, any person who does not 
desire or is not able to maintain a schedule II registration must 
surrender all quantities of currently held thiafentanil, or may 
transfer all quantities of currently held thiafentanil to a person 
registered with the DEA in accordance with 21 CFR part 1317, in 
addition to all other applicable federal, state, local, and tribal 
laws.
    4. Security. Thiafentanil is subject to schedule II security 
requirements and must be handled and stored pursuant to 21 U.S.C. 821 
and 823, and in accordance with 21 CFR 1301.71-1301.93.
    5. Labeling and Packaging. All labels, labeling, and packaging for 
commercial containers of thiafentanil must comply with 21 U.S.C. 825 
and 958(e), and be in accordance with 21 CFR part 1302. In addition, 
thiafentanil is subject to additional labeling requirements provided by 
FDA. Thiafentanil must be labeled, distributed, and promoted in 
accordance with the Index entry of the new animal drug and the FDA may 
remove a new animal drug from the Index if the conditions and 
limitations of use have not been followed. 21 U.S.C. 360ccc-l(d)(l)(G); 
(f)(l)(F). The labeling of an indexed new animal drug must prominently 
state that the extra-label use of the product is prohibited. 21 U.S.C. 
360ccc-l(h).
    6. Inventory. Every DEA registrant who desires to possess any 
quantity of thiafentanil must take an inventory of thiafentanil on 
hand, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 
1304.03, 1304.04, and 1304.11.
    Any person who becomes registered with the DEA to handle 
thiafentanil must take an initial inventory of all stocks of controlled 
substances (including thiafentanil) on hand on the date the registrant 
first engages in the handling of controlled substances, pursuant to 21 
U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 
1304.11.
    After the initial inventory, every DEA registrant must take a new 
inventory of all stocks of controlled substances (including 
thiafentanil) on hand every two years, pursuant to 21 U.S.C. 827 and 
958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
    7. Records and Reports. Every DEA registrant must maintain records 
and submit reports for thiafentanil, or products containing 
thiafentanil, pursuant to 21 U.S.C. 827 and 958(e), and in accordance 
with 21 CFR parts 1304, 1312, and 1317.
    8. Orders for thiafentanil. Every DEA registrant who distributes 
thiafentanil is required to comply with order form requirements, 
pursuant to 21 U.S.C. 828, and in accordance with 21 CFR part 1305.
    9. Prescriptions and other dispensing. All prescriptions for 
thiafentanil or products containing thiafentanil must comply with 21 
U.S.C. 829, and be issued in accordance with 21 CFR parts 1306 and 
1311, subpart C. Moreover, given that thiafentanil is not the subject 
of an approved new drug application under the FDCA, and that it is only 
allowed under the MUMS Act amendments to the FDCA to be marketed for 
extremely limited use in minor species, DEA would not consider any 
dispensing of thiafentanil for human use to be for a legitimate medical 
purpose within the meaning of the CSA. Likewise, DEA would not consider 
any dispensing of thiafentanil for animal use beyond the scope of the 
drug's labeling authorized under the MUMS Act amendments to the FDCA to 
be for a legitimate medical purpose within the meaning of the CSA.
    10. Manufacturing and Distributing. In addition to the general 
requirements of the CSA and DEA regulations that are applicable to 
manufacturers and distributors of schedule II controlled substances, 
such registrants should be advised that (consistent with the foregoing 
considerations) any manufacturing or distribution of thiafentanil may 
only be for the legitimate purposes consistent with the drug's labeling 
authorized under the MUMS Act, or for research activities authorized by 
the FDCA and CSA.
    11. Importation and Exportation. All importation and exportation of 
thiafentanil must be in compliance with 21 U.S.C. 952, 953, 957, and 
958, and in accordance with 21 CFR part 1312.
    12. Liability. Any activity involving thiafentanil not authorized 
by, or in violation of, the CSA or its implementing regulations, is 
unlawful, and may subject the person to administrative, civil, and/or 
criminal sanctions.

Regulatory Analyses

Administrative Procedure Act

    Public Law 114-89 was signed into law, amending 21 U.S.C. 811. This 
amendment provides that in cases where a new drug is (1) approved or 
indexed by the Department of Health and Human Services (HHS) and (2) 
HHS recommends control in CSA schedule II-V, the DEA shall issue an 
interim final rule scheduling the drug within 90 days. Additionally, 
the law specifies that the rulemaking shall become immediately 
effective as an interim final rule without requiring the DEA to 
demonstrate good cause. Therefore, the DEA has determined that the 
notice and comment requirements of section 553 of the APA, 5 U.S.C. 
553, do not apply to this scheduling action.

Executive Orders 12866, Regulatory Planning and Review, and 13563, 
Improving Regulation and Regulatory Review

    In accordance with Public Law 114-89, this scheduling action is 
subject to formal rulemaking procedures performed ``on the record after 
opportunity for a hearing,'' which are conducted pursuant to the 
provisions of 5 U.S.C. 556 and 557. The CSA sets forth the procedures 
and criteria for scheduling a drug or other substance. Such actions are 
exempt from review by the Office of Management and Budget (OMB) 
pursuant to section 3(d)(1) of Executive Order 12866 and the principles 
reaffirmed in Executive Order 13563.

Executive Order 12988, Civil Justice Reform

    This regulation meets the applicable standards set forth in 
sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate 
drafting errors and ambiguity, minimize litigation, provide a clear 
legal standard for affected conduct, and promote simplification and 
burden reduction.

Executive Order 13132, Federalism

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

[[Page 58839]]

responsibilities among the various levels of government.

Executive Order 13175, Consultation and Coordination With Indian Tribal 
Governments

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

Regulatory Flexibility Act

    In accordance with 5 U.S.C. 603(a), ``[w]henever an agency is 
required by [5 U.S.C. 553], or any other law, to publish general notice 
of proposed rulemaking for any proposed rule, or publishes a notice of 
proposed rulemaking for an interpretive rule involving the internal 
revenue laws of the United States, the agency shall prepare and make 
available for public comment an initial regulatory flexibility 
analysis.'' As noted in the above discussion regarding applicability of 
the Administrative Procedure Act, the DEA has determined that the 
notice and comment requirements of section 553 of the APA, 5 U.S.C. 
553, do not apply to this scheduling action. Consequently, the RFA does 
not apply to this interim final rule.

Unfunded Mandates Reform Act of 1995

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

Paperwork Reduction Act of 1995

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

Congressional Review Act

    This rule is not a major rule as defined by section 804 of the 
Small Business Regulatory Enforcement Fairness Act of 1996 
(Congressional Review Act (CRA)). This rule will not result in: An 
annual effect on the economy of $100,000,000 or more; a major increase 
in costs or prices for consumers, individual industries, Federal, 
State, or local government agencies, or geographic regions; or 
significant adverse effects on competition, employment, investment, 
productivity, innovation, or on the ability of U.S.-based companies to 
compete with foreign based companies in domestic and export markets. 
However, pursuant to the CRA, the DEA has submitted a copy of this 
interim final rule to both Houses of Congress and to the Comptroller 
General.

List of Subjects

21 CFR Part 1301

    Administrative practice and procedure, Drug traffic control, 
Security measures.

21 CFR Part 1305

    Drug traffic control, Reporting and recordkeeping requirements.

21 CFR Part 1308

    Administrative practice and procedure, Drug traffic control, 
Reporting and recordkeeping requirements.

    For the reasons set out above, the DEA amends 21 CFR parts 1301, 
1305 and 1308 as follows:

PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND 
DISPENSERS OF CONTROLLED SUBSTANCES

0
1. The authority citation for 21 CFR part 1301 continues to read as 
follows:

    Authority: 21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877, 
886a, 951, 952, 953, 956, 957, 958, 965.


0
2. In Sec.  1301.74, revise paragraph (g) to read as follows:


Sec.  1301.74  Other security controls for non-practitioners; narcotic 
treatment programs and compounders for narcotic treatment programs.

* * * * *
    (g) Before the initial distribution of thiafentanil, carfentanil, 
etorphine hydrochloride and/or diprenorphine to any person, the 
registrant must verify that the person is authorized to handle the 
substance(s) by contacting the Drug Enforcement Administration.
* * * * *

0
3. In Sec.  1301.75, revise paragraph (e) to read as follows:


Sec.  1301.75  Physical security controls for practitioners.

* * * * *
    (e) Thiafentanil, carfentanil, etorphine hydrochloride and 
diprenorphine shall be stored in a safe or steel cabinet equivalent to 
a U.S. Government Class V security container.

PART 1305--ORDERS FOR SCHEDULE I AND II CONTROLLED SUBSTANCES

0
4. The authority citation for 21 CFR part 1305 continues to read as 
follows:

    Authority: 21 U.S.C. 821, 828, 871(b), unless otherwise noted.


0
5. In Sec.  1305.07, revise the introductory text and paragraph (a) to 
read as follows:


Sec.  1305.07  Special procedure for filling certain orders.

    A supplier of thiafentanil, carfentanil, etorphine hydrochloride, 
or diprenorphine, if he or she determines that the purchaser is a 
veterinarian engaged in zoo and exotic animal practice, wildlife 
management programs, or research, and is authorized by the 
Administrator to handle these substances, may fill the order in 
accordance with the procedures set forth in Sec.  1305.17 except that:
    (a) A DEA Form 222 or an electronic order for thiafentanil, 
carfentanil, etorphine hydrochloride, and diprenorphine must contain 
only these substances in reasonable quantities.
* * * * *

0
6. In Sec.  1305.17, revise paragraph (d) to read as follows:


Sec.  1305.17  Preservation of DEA Forms 222.

* * * * *
    (d) The supplier of thiafentanil, carfentanil, etorphine 
hydrochloride, and diprenorphine must maintain DEA Forms 222 for these 
substances separately from all other DEA Forms 222 and records required 
to be maintained by the registrant.

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
7. The authority citation for 21 CFR part 1308 continues to read as 
follows:

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


0
8. In Sec.  1308.12, add paragraph (c)(29) to read as follows:


Sec.  1308.12  Schedule II.

* * * * *
    (c) * * *

(29) Thiafentanil...............................................    9729
 

* * * * *


[[Page 58840]]


    Dated: August 18, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-20463 Filed 8-25-16; 8:45 am]
 BILLING CODE 4410-09-P