Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Rules and Regulations 14815

DEPARTMENT OF JUSTICE • Electronic comments: The Drug Information Act (FOIA) applies to all Enforcement Administration encourages comments received. If you want to Drug Enforcement Administration that all comments be submitted submit personal identifying information electronically through the Federal (such as your name, address, etc.) as 21 CFR Part 1308 eRulemaking Portal, which provides the part of your comment, but do not want [Docket No. DEA–344] ability to type short comments directly it to be made publicly available, you into the comment field on the Web page must include the phrase ‘‘PERSONAL Schedules of Controlled Substances: or attach a file for lengthier comments. IDENTIFYING INFORMATION’’ in the Placement of FDA-Approved Products Please go to http://www.regulations.gov first paragraph of your comment. You of Oral Solutions Containing and follow the online instructions at must also place all of the personal Dronabinol [(-)-delta-9-trans- that site for submitting comments. Upon identifying information you do not want tetrahydrocannabinol (delta-9-THC)] in completion of your submission, you will made publicly available in the first Schedule II receive a Comment Tracking Number for paragraph of your comment and identify your comment. Please be aware that what information you want redacted. AGENCY: Drug Enforcement submitted comments are not If you want to submit confidential Administration, Department of Justice. instantaneously available for public business information as part of your ACTION: Interim final rule, with request view on Regulations.gov. If you have comment, but do not want it to be made for comments. received a Comment Tracking Number, publicly available, you must include the phrase ‘‘CONFIDENTIAL BUSINESS SUMMARY: On July 1, 2016, the U.S. Food your comment has been successfully INFORMATION’’ in the first paragraph and Drug Administration (FDA) submitted and there is no need to of your comment. You must also approved a new drug application for resubmit the same comment. • prominently identify the confidential Syndros, a drug product consisting of Paper comments: Paper comments business information to be redacted dronabinol [(-)-delta-9-trans- that duplicate the electronic submission are not necessary and are discouraged. within the comment. tetrahydrocannabinol (delta-9-THC)] Comments containing personal oral solution. Thereafter, the Should you wish to mail a paper comment in lieu of an electronic identifying information and confidential Department of Health and Human business information identified as Services (HHS) provided the Drug comment, it should be sent via regular or express mail to: Drug Enforcement directed above will generally be made Enforcement Administration (DEA) with publicly available in redacted form. If a a scheduling recommendation that Administration, Attn: DEA Federal Register Representative/DRW, 8701 comment has so much confidential would result in Syndros (and other oral business information or personal solutions containing dronabinol) being Morrissette Drive, Springfield, VA 22152. identifying information that it cannot be placed in schedule II of the Controlled effectively redacted, all or part of that Substances Act (CSA). In accordance • Hearing requests: All requests for hearing and waivers of participation comment may not be made publicly with the CSA, as revised by the available. Comments posted to http:// Improving Regulatory Transparency for must be sent to: Drug Enforcement Administration, Attn: Acting www.regulations.gov may include any New Medical Therapies Act, DEA is personal identifying information (such Administrator, 8701 Morrissette Drive, hereby issuing an interim final rule as name, address, and phone number) Springfield, Virginia 22152. All requests placing FDA-approved products of oral included in the text of your electronic for hearing and waivers of participation solutions containing dronabinol in submission that is not identified as should also be sent to: (1) Drug schedule II of the CSA. directed above as confidential. DATES: The effective date of this Enforcement Administration, Attn: An electronic copy of this document rulemaking is March 23, 2017. Hearing Clerk/LJ, 8701 Morrissette and supplemental information, Interested persons may file written Drive, Springfield, Virginia 22152; and including the complete Department of comments on this rulemaking in (2) Drug Enforcement Administration, Health and Human Services and Drug accordance with 21 CFR 1308.43(g). Attn: DEA Federal Register Enforcement Administration eight-factor Electronic comments must be Representative/DRW, 8701 Morrissette analyses, to this interim final rule are submitted, and written comments must Drive, Springfield, Virginia 22152. available at http://www.regulations.gov be postmarked, on or before April 24, FOR FURTHER INFORMATION CONTACT: for easy reference. 2017. Commenters should be aware that Michael J. Lewis, Diversion Control the electronic Federal Docket Division, Drug Enforcement Request for Hearing, Notice of Management System will not accept Administration; Mailing Address: 8701 Appearance at Hearing, or Waiver of comments after 11:59 p.m. Eastern Time Morrissette Drive, Springfield, Virginia Participation in Hearing on the last day of the comment period. 22152; Telephone: (202) 598–8953. Pursuant to 21 U.S.C. 811(a), this Interested persons, defined at 21 CFR SUPPLEMENTARY INFORMATION: action is a formal rulemaking ‘‘on the 1300.01 as those ‘‘adversely affected or record after opportunity for a hearing.’’ aggrieved by any rule or proposed rule Posting of Public Comments Such proceedings are conducted issuable pursuant to section 201 of the Please note that all comments pursuant to the provisions of the Act (21 U.S.C. 811),’’ may file a request received are considered part of the Administrative Procedure Act (APA), 5 for hearing or waiver of hearing public record. They will, unless U.S.C. 551–559. 21 CFR 1308.41– pursuant to 21 CFR 1308.44. Requests reasonable cause is given, be made 1308.45; 21 CFR part 1316, subpart D. for hearing and waivers of an available by the Drug Enforcement In accordance with 21 CFR 1308.44(a) opportunity for a hearing or to Administration (DEA) for public through (c), requests for a hearing, participate in a hearing must be inspection online at http:// notices of appearance, and waivers of an received on or before April 24, 2017. www.regulations.gov. Such information opportunity for a hearing or to ADDRESSES: To ensure proper handling includes personal identifying participate in a hearing may be of comments, please reference ‘‘Docket information (such as your name, submitted only by interested persons, No. DEA–344’’ on all correspondence, address, etc.) voluntarily submitted by defined as those ‘‘adversely affected or including any attachments. the commenter. The Freedom of aggrieved by any rule or proposed rule

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issuable pursuant to section 201 of the newly approved drugs that are currently scientific and medical evaluation Act (21 U.S.C. 811).’’ 21 CFR 1300.01. either in schedule I or not controlled contained an eight-factor analysis of the Requests for a hearing and notices of (but which have sufficient abuse abuse potential of FDA-approved participation must conform to the potential to warrant control) so that products of oral solutions containing requirements of 21 CFR 1308.44(a) or such drugs may be marketed without dronabinol and recommended that such (b), as applicable, and include a undue delay following FDA approval.1 products be placed in schedule II of the statement of the interest of the person in Subsection (j) further provides that CSA. the proceeding and the objections or the interim final rule shall give In response, the DEA reviewed the issues, if any, concerning which the interested persons the opportunity to scientific and medical evaluation and person desires to be heard. Any waiver comment and to request a hearing. After scheduling recommendation provided of an opportunity for a hearing must the conclusion of such proceedings, by the HHS, along with all other conform to the requirements of 21 CFR DEA must issue a final rule in relevant data, and completed its own 1308.44(c) including a written statement accordance with the scheduling criteria eight-factor review document pursuant regarding the interested person’s of subsections 21 U.S.C. 811(b), (c), and to 21 U.S.C. 811(c). The DEA concluded position on the matters of fact and law (d) and 21 U.S.C. 812(b). that FDA-approved dronabinol oral involved in any hearing. solutions met the 21 U.S.C. 812(b)(2) Please note that pursuant to 21 U.S.C. Background criteria for placement in schedule II of 811(a), the purpose and subject matter Syndros is an oral solution that the CSA. of the hearing are restricted to ‘‘(A) contains 5 mg of dronabinol (delta-9- Pursuant to subsection 811(j), and find[ing] that such drug or other THC) per mL of solution. Dronabinol is based on the HHS recommendation, substance has a potential for abuse, and the generic name (International NDA approval by HHS/FDA, and DEA’s (B) mak[ing] with respect to such drug Nonproprietary Name, INN) for the (-) determination, DEA is issuing this or other substance the findings delta-9-trans isomer of interim final rule to schedule FDA- prescribed by subsection (b) of section tetrahydrocannabinol (THC), the approved dronabinol oral solution as a 812 of this title for the schedule in primary psychoactive substance in schedule II controlled substance under which such drug is to be placed * * *.’’ marijuana. On June 1, 2015, Insys the CSA. Requests for a hearing and waivers of Therapeutics (Sponsor) submitted an Included below is a brief summary of participation in the hearing should be NDA to the U.S. Food and Drug each factor as analyzed by the HHS and submitted to DEA using the address Administration (FDA) for Syndros, an the DEA, and as considered by the DEA information provided above. oral formulation of dronabinol. The in its scheduling action. Please note that both the DEA and HHS analyses are Legal Authority FDA accepted the NDA filing for Syndros on August 6, 2015 and available in their entirety under Under the Improving Regulatory approved the NDA on July 5, 2016. On ‘‘Supporting Documents’’ in the public Transparency for New Medical December 28, 2016, the DEA received docket for this interim final rule at Therapies Act (Pub. L. 114–89), which notification that HHS/FDA approved http://www.regulations.gov, under was signed into law on November 25, Syndros for the treatment of anorexia Docket Number ‘‘DEA–344.’’ Full 2015, DEA is required to commence an associated with weight loss in patients analysis of, and citations to, the expedited scheduling action with with Acquired Immune Deficiency information referenced in the summary respect to certain new drugs approved Syndrome (AIDS), and for the treatment may also be found in the supporting and by the FDA. As provided in 21 U.S.C. of nausea and vomiting resulting from related material. 811(j), this expedited scheduling is cancer chemotherapy in patients who 1. Its Actual or Relative Potential for required where both of the following failed to respond to conventional anti- Abuse: Dronabinol is a generic name for conditions apply: (1) The Secretary of emetic therapies. the (-) delta-9-trans isomer of HHS has advised DEA that a New Drug tetrahydrocannabinol (THC). THC is the Application (NDA) has been submitted Determination To Schedule FDA- primary psychoactive substance in for a drug that has a stimulant, Approved Products Containing marijuana. Dronabinol is the active depressant, or hallucinogenic effect on Dronabinol in an Oral Solution pharmaceutical ingredient in Syndros. the central nervous system, and that it On December 28, 2016, the HHS As stated by HHS, Marinol (synthetic appears that such drug has an abuse provided the DEA with a scientific and dronabinol in sesame oil and potential and (2) the Secretary medical evaluation and scheduling encapsulated in a soft gelatin capsule) recommends that DEA control the drug recommendation related to dronabinol. was approved by the FDA for medical in schedule II, III, IV, or V pursuant to Because DEA’s authority to issue this use on May 31, 1985 and placed in 21 U.S.C. 811(a) and (b). In these interim final rule under subsection schedule II based on its accepted circumstances, DEA is required to issue 811(j) is limited to drugs that are the medical use and high abuse potential. an interim final rule controlling the subject of an approved NDA, and On July 2, 1999, Marinol was drug within 90 days. because the NDA was limited to an oral rescheduled from schedule II to The law further states that the 90-day solution containing dronabinol, DEA’s schedule III because of the findings of timeframe starts the later of (1) the date discussion here of the scheduling the DEA that the difficulty of separating DEA receives the HHS scientific and criteria is likewise limited to oral dronabinol from the sesame oil medical evaluation/scheduling solutions containing dronabinol in FDA- formulation and the delayed onset of recommendation or (2) the date DEA approved drug products.2 HHS’s behavioral effects due to oral route receives notice of the NDA approval by administration supported a lower abuse HHS. In addition, the law specifies that 1 Given the parameters of subsection (j), in DEA’s potential of Marinol as compared to the rulemaking shall become view, it would not apply to a reformulation of a substances in Schedule II. 64 FR 35928. immediately effective as an interim final drug containing a substance currently in schedules According to HHS, although Syndros rule without requiring the DEA to II through V for which an NDA has recently been approved. oral solution and Marinol capsules have demonstrate good cause therefor. Thus, 2 To the extent HHS’s submissions to DEA are the purpose of subsection (j) is to speed outside the scope of this interim final rule (i.e., in an FDA-approved oral solution), they will not be the process by which DEA schedules those addressing dronabinol beyond that contained addressed in this document.

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the same pharmacology, these dizziness, nausea, tachycardia, analysis of marijuana users, 12 percent formulations differ in their physical and euphoria, enhanced sensory perception, of users preferred vaping the drug over chemical properties. Both these heightened imagination, impaired any other method and considered it a formulations have abuse potential as judgment, emotional lability, and safer alternative to smoking. As a result, demonstrated by their effects on increased appetite. Dronabinol has been these data suggest that if dronabinol subjective scores of ‘‘Drug Liking’’ in reported to be self-administered extracts or concentrates are available human abuse potential studies. HHS intravenously by squirrel monkeys and from dronabinol sources such as indicated that the formulation of intracerebroventricularly by rats. Syndros, a certain percent of the Syndros (oral solution) is easier to abuse Discriminative stimulus effects of population are likely to vape these than Marinol because this liquid dronabinol are specific to CB1 substances. formulation can be manipulated to cannabinoids, and unique because 5. The Scope, Duration, and produce concentrated extracts of stimulants, hallucinogens, opioids, Significance of Abuse: As noted by dronabinol for abuse by inhalation benzodiazepines, barbiturates, NMDA HHS, information on the scope, (smoking or vaping) or through other antagonists, and antipsychotics do not duration, and significance of abuse of routes of administration. Because of the generalize to dronabinol. dronabinol was considered for both oral large amount of dronabinol in Syndros 3. The State of Current Scientific and inhalation routes. Data analyzed oral solution it has a greater potential Knowledge Regarding the Drug or Other from the 2014 Summer Styles Survey, a for extraction than Marinol and thus has Substance: Dronabinol is the generic national representative consumer panel a greater abuse potential. Based on the name for (-)delta-9-trans- survey of adult marijuana users aged 18 data from in vitro studies conducted by tetrahydrocannabinol (THC) and is or older, showed that the majority of the Sponsor, the large amount of chemically known as (-)-(6aR-trans)- current marijuana users prefer smoking dronabinol in the Syndros formulation, 6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3- marijuana. In the same survey, it was its pharmacokinetics upon oral pentyl-6H-dibenzo[b,d]pyran-1-ol and reported that 16 percent of the current administration, and its contribution to has the chemical formula C21H30O2. At ° users consumed THC containing edibles marijuana psychoactivity, HHS stated room temperature (25 C), dronabinol is or drinks. Individuals who preferred that the abuse potential of the a light-yellow oil and hardens upon ° vaping (using a device to vaporize dronabinol oral solution is similar to refrigeration (4 C) and is insoluble in liquid THC) believed that vaping is that of other THC containing products water. The FDA-approved Syndros ‘‘healthier, better tasting’’ and resulted such as concentrates, infused edibles formulation consists of 5 mg in ‘‘better effects’’ associated with and drinks. Similar to these THC dronabinol/mL of a 50 percent w/w marijuana and THC. alcoholic solution. Syndros will be containing products, Syndros oral 6. What, if any, Risk There is to the marketed as 30 mL aliquots in clear, solution can be easily manipulated to Public Health: As stated by HHS, other forms that can be easily abused amber glass bottles and each bottle will labeling on the Marinol packaging through inhalation and oral routes of contain 150 mg dronabinol. indicates that Central Nervous System administration. In vitro manipulation studies with The 2014 and 2015 Monitoring the Syndros and Marinol (positive control) (CNS) adverse reactions are dose-related Future (MTF) 3 survey indicated that were conducted by the Sponsor. It was and subject to patient variability. CNS THC containing products are being found that Syndros oral solution and adverse reactions are more likely to taken orally, smoked, and vaporized Marinol capsules differ in their occur at higher doses of dronabinol. using devices such as e-cigarettes. There physiochemical properties. Specifically, Following oral Marinol (dronabinol) is a lack of evidence pertaining to Syndros, unlike Marinol, can be doses of 0.4 mg/kg, CNS symptoms such diversion of Syndros or Marinol from manipulated such that the dronabinol as amnesia, confusion, delusions, legitimate drug channels. Syndros is not can be evaporated into residues that can depression, and hallucinations have yet available on the market. Marinol and be reconstituted for smoking or abused been observed. According to HHS, it is generic forms that reference it, have low intravenously. According to HHS, assumed that Syndros oral solution will levels of abuse and diversion according Syndros contains a large amount of have similar adverse effects to Marinol. to the HHS and DEA, and this is dronabinol (150 mg of dronabinol in 30 One concern with Syndros is that there attributed to the formulation of mL of solution) and would be an easily is a large amount of dronabinol present dronabinol in sesame oil. accessible source for abuse via the oral in the product (150 mg dronabinol per 2. Scientific Evidence of Its route. bottle, 30 mL solution) that can easily be Pharmacological Effects, if Known: 4. Its History and Current Pattern of abused orally and may result in Dronabinol, also known as THC, is the Abuse: There is a long history of abuse unintended overdoses. primary psychoactive substance in of THC in the United States. HHS noted Oral consumption of dronabinol, marijuana and is also the active that dronabinol in Marinol capsules is compared to inhaled THC, may result in pharmaceutical ingredient in Syndros difficult to extract and therefore, cannot psychoactive effects that are delayed and Marinol. Dronabinol binds to and be used for smoking, vaping, or as an and stronger with an increased risk of activates the cannabinoid receptors edible. The dronabinol in Syndros, experiencing serious adverse events. (CB1 and CB2). HHS states that CB1 however, is relatively easy to extract When dronabinol (THC) is smoked, the receptors activation underlie the and concentrated forms can be used for drug rapidly reaches the brain and psychotropic effects and many other smoking, vaping, or the sweetened psychoactive effects are felt within pharmacological effects of dronabinol. alcoholic dronabinol in Syndros can be minutes of inhalation, which allows the Some behavioral and other effects of used as a substitute for THC in edibles. subject to control the dose more readily. dronabinol in humans consist of In the 2015 MTF survey, it was reported Due to the absorption and metabolism that teens were more likely to use e- by the liver following oral ingestion of 3 MTF is a research program conducted at the cigarettes (vaping) than regular dronabinol, it takes longer for an University of Michigan’s Institute for Social cigarettes (smoking). In this survey, 6.1 individual to feel the psychoactive Research, under grants from NIDA. MTF tracks drug use trends among American adolescents in the 8th, percent of 12th graders reported effects. Therefore, the individual may 10th, and 12th grades and high school graduates vaporizing marijuana or hash oil in their underestimate the ingestion amount into adulthood by conducting national surveys. last e-cigarette. Additionally, in a recent needed to feel the psychoactive effects

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which may potentially result in an edibles or drinks. These data reverse distributes, dispenses, imports, overdose. collectively indicate FDA-approved oral exports, engages in research, or 7. Its Psychic or Physiological solutions containing dronabinol have conducts instructional activities or Dependence Liability: As stated in high potential for abuse. chemical analysis with, or possesses) labeling for Marinol and Syndros, 2. FDA-approved products containing FDA-approved products containing psychological and physical dependence dronabinol in an oral solution have a dronabinol in an oral solution, or who has been observed in healthy currently accepted medical use in desires to handle such products, must individuals following use of dronabinol. treatment in the United States. The FDA be registered with the DEA to conduct Abrupt discontinuation of dronabinol in approved an oral solution containing such activities pursuant to 21 U.S.C. individuals receiving 210 mg/day (25 dronabinol (Syndros) for the treatment 822, 823, 957, and 958 and in times the recommended daily dose for of anorexia associated with weight loss accordance with 21 CFR parts 1301 and the treatment of anorexia associated in patients with AIDS, and for the 1312. Any person who currently with weight loss in AIDS patients) for treatment of nausea and vomiting handles FDA-approved products 12 to 16 days resulted in undesirable associated with cancer chemotherapy in containing dronabinol in an oral symptoms including insomnia, patients who have failed to respond solution, and is not registered with the irritability, and restlessness at 12 hours adequately to conventional antiemetic DEA, must submit an application for after discontinuation. These symptoms treatments. registration and may not continue to worsened to include hot flashes, 3. FDA-approved products containing handle such products, unless the DEA anorexia, sweating, rhinorrhea, loose dronabinol in an oral solution may lead has approved that application for stools, and hiccoughs at 24 hours after to severe physical dependence. registration, pursuant to 21 U.S.C. 822, discontinuation of dronabinol. Following discontinuation of 823, 957, and 958, and in accordance 8. Whether the Substance is an dronabinol at a dose 210 mg/day (25 with 21 CFR parts 1301 and 1312. Immediate Precursor of a Substance times higher than the recommended 2. Quota. Only registered Already Controlled under the CSA: daily dose for anorexia associated with manufacturers are permitted to Dronabinol oral solution is not an weight loss in AIDS patients) for 12 to manufacture FDA-approved products immediate precursor of any controlled 16 consecutive days, withdrawal containing dronabinol in an oral substance. symptoms including irritability, solution in accordance with a quota Conclusion: After considering the insomnia, and restlessness were assigned pursuant to 21 U.S.C. 826 and scientific and medical evaluation observed at 12 hours after in accordance with 21 CFR part 1303. conducted by the HHS, the HHS’ discontinuation. These withdrawal 3. Disposal of stocks. Upon obtaining recommendation, and its own eight- symptoms worsened to include hot a schedule II registration to handle FDA- factor analysis, the DEA has determined flashes, sweating, rhinorrhea, loose approved products containing that these facts and all relevant data stools, hiccoughs, and anorexia at 24 dronabinol in an oral solution, any constitute substantial evidence of a hours after discontinuation of person who does not desire or is not potential for abuse of dronabinol oral dronabinol. The withdrawal symptoms able to maintain such registration must solution. As such, the DEA hereby decreased gradually over the next 48 surrender all quantities of such schedules FDA-approved products hours and patients reported having products, or may transfer all quantities containing dronabinol oral solution as disturbed sleep for several weeks after of such products to a person registered controlled substances under the CSA. discontinuation of dronabinol. with the DEA in accordance with 21 Based on these findings, the Acting Determination of Appropriate Schedule CFR part 1317, in addition to all other Administrator of the DEA concludes applicable federal, state, local, and tribal The CSA lists the findings required to that FDA-approved products containing laws. place a drug or other substance in any dronabinol [(-)-delta-9-trans 4. Security. FDA-approved products particular Schedule (I, II, III, IV, or V). tetrahydrocannabinol (delta-9-THC)] in containing dronabinol in an oral 21 U.S.C. 812(b). After consideration of an oral solution warrant control in solution are subject to schedule II the analysis and recommendation of the schedule II of the CSA. 21 U.S.C. security requirements and must be Assistant Secretary for Health of the 812(b)(2). handled and stored pursuant to 21 HHS and review of all available data, U.S.C. 821, 823, and in accordance with Requirements for Handling FDA- the Acting Administrator of the DEA, 21 CFR 1301.71–1301.93. pursuant to 21 U.S.C. 812(b)(2), finds Approved Products Containing 5. Labeling and Packaging. All labels, that: Dronabinol in an Oral Solution. labeling, and packaging for commercial 1. FDA-approved products containing Preliminarily, it should be noted that containers of FDA-approved products dronabinol in an oral solution have a any form of dronabinol other than in an containing dronabinol in an oral high potential for abuse. The FDA-approved drug product remains a solution must comply with 21 U.S.C. physicochemical properties of Syndros schedule I controlled substance, and 825 and 958(e), and be in accordance allow extraction of dronabinol for abuse those who handle such material remain with 21 CFR part 1302. through oral or inhalation (smoking or subject to the regulatory controls, and 6. Inventory. Every DEA registrant vaping) routes. Dronabinol is not easily administrative, civil, and criminal who possesses any quantity of FDA- extractable from Marinol. Oral abuse of sanctions, applicable to schedule I approved products containing dronabinol-containing products is controlled substances set forth in the dronabinol in an oral solution must take associated with hallucinations, mood CSA and DEA regulations. However, for an inventory of such products on hand, alterations, and paranoia. The 2015 those who handle dronabinol oral pursuant to 21 U.S.C. 827 and 958, and MTF Survey reported that 6.1 percent of solution exclusively in the form of an in accordance with 21 CFR 1304.03, the 12th graders used e-cigarettes to FDA-approved drug product, the 1304.04, and 1304.11. vaporize marijuana or cannabinoid following is a summary of the schedule Any person who becomes registered substances. Similarly, the 2014 Summer II regulatory requirements that apply as with the DEA to handle FDA-approved Styles Survey, 16 percent of current a result of this interim final rule: products containing dronabinol in an marijuana users indicated that they have 1. Registration. Any person who oral solution must take an initial consumed dronabinol containing handles (manufactures, distributes, inventory of all stocks of controlled

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substances (including FDA-approved Regulatory Analyses have substantial direct effects on one or products containing dronabinol in an more Indian tribes, on the relationship Administrative Procedure Act oral solution) on hand on the date the between the Federal government and registrant first engages in the handling As explained above, under 21 U.S.C. Indian tribes, or on the distribution of of controlled substances, pursuant to 21 811(j), where a new drug is (1) approved power and responsibilities between the U.S.C. 827 and 958, and in accordance by the Department of Health and Human Federal government and Indian tribes. with 21 CFR 1304.03, 1304.04, and Services (HHS) and (2) HHS Regulatory Flexibility Act 1304.11. recommends control in CSA schedule After the initial inventory, every DEA II–V, the DEA is required to issue an In accordance with 5 U.S.C. 603(a), registrant must take a new inventory of interim final rule scheduling the drug ‘‘[w]henever an agency is required by [5 all stocks of controlled substances within 90 days. Additionally, the law U.S.C. 553], or any other law, to publish (including FDA-approved products specifies that the rulemaking shall general notice of proposed rulemaking containing dronabinol in an oral become immediately effective as an for any proposed rule, or publishes a solution) on hand every two years, interim final rule without requiring the notice of proposed rulemaking for an pursuant to 21 U.S.C. 827 and 958, and DEA to demonstrate good cause. interpretive rule involving the internal in accordance with 21 CFR 1304.03, Therefore, the standard notice-and- revenue laws of the United States, the 1304.04, and 1304.11. comment requirements of section 553 of agency shall prepare and make available the APA, 5 U.S.C. 553, do not apply to for public comment an initial regulatory 7. Records and Reports. Every DEA this scheduling action. flexibility analysis.’’ As noted in the registrant must maintain records and above discussion regarding applicability Executive Orders 12866, Regulatory submit reports for FDA-approved of the Administrative Procedure Act, the Planning and Review, and 13563, products containing dronabinol in an notice-and-comment requirements of Improving Regulation and Regulatory oral solution, pursuant to 21 U.S.C. 827 section 553 of the APA, 5 U.S.C. 553, do Review and 958(e), and in accordance with 21 not apply to this scheduling action. CFR parts 1304, 1312, and 1317. In accordance with 21 U.S.C. 811(j), Consequently, the RFA does not apply 8. Orders for FDA-approved products this scheduling action is subject to to this interim final rule. containing dronabinol in an oral formal rulemaking procedures solution. Every DEA registrant who performed ‘‘on the record after Unfunded Mandates Reform Act of 1995 distributes FDA-approved products opportunity for a hearing,’’ which are In accordance with the Unfunded containing dronabinol in an oral conducted pursuant to the provisions of Mandates Reform Act (UMRA) of 1995, solution is required to comply with 5 U.S.C. 556 and 557. The CSA sets 2 U.S.C. 1501 et seq., the DEA has order form requirements, pursuant to 21 forth the procedures and criteria for determined that this action would not U.S.C. 828, and in accordance with 21 scheduling a drug or other substance. result in any Federal mandate that may CFR part 1305. Such actions are exempt from review by result ‘‘in the expenditure by State, 9. Prescriptions. All prescriptions for the Office of Management and Budget local, and tribal governments, in the FDA-approved products containing (OMB) pursuant to section 3(d)(1) of aggregate, or by the private sector, of dronabinol in an oral solution must Executive Order 12866 and the $100,000,000 or more (adjusted for comply with 21 U.S.C. 829, and be principles reaffirmed in Executive Order inflation) in any one year.’’ Therefore, issued in accordance with 21 CFR parts 13563. neither a Small Government Agency 1306 and 1311, subpart C. Plan nor any other action is required Executive Order 12988, Civil Justice under UMRA of 1995. 10. Manufacturing and Distributing. Reform In addition to the general requirements Paperwork Reduction Act of 1995 of the CSA and DEA regulations that are This regulation meets the applicable This action does not impose a new applicable to manufacturers and standards set forth in sections 3(a) and collection of information requirement distributors of schedule II controlled 3(b)(2) of Executive Order 12988 to under the Paperwork Reduction Act of substances, such registrants should be eliminate drafting errors and ambiguity, 1995. 44 U.S.C. 3501–3521. This action advised that (consistent with the minimize litigation, provide a clear legal would not impose recordkeeping or foregoing considerations) any standard for affected conduct, and reporting requirements on State or local manufacturing or distribution of FDA- promote simplification and burden governments, individuals, businesses, or approved products containing reduction. organizations. An agency may not dronabinol in an oral solution may only Executive Order 13132, Federalism conduct or sponsor, and a person is not be for the legitimate purposes This rulemaking does not have required to respond to, a collection of authorized by the FDCA and CSA. federalism implications warranting the information unless it displays a 11. Importation and Exportation. All application of Executive Order 13132. currently valid OMB control number. importation and exportation of FDA- The rule does not have substantial Congressional Review Act approved products containing direct effects on the States, on the dronabinol in an oral solution must be relationship between the national This rule is not a major rule as in compliance with 21 U.S.C. 952, 953, government and the States, or on the defined by section 804 of the Small 957, and 958, and in accordance with 21 distribution of power and Business Regulatory Enforcement CFR part 1312. responsibilities among the various Fairness Act of 1996 (Congressional 12. Liability. Any activity involving levels of government. Review Act (CRA)). This rule will not FDA-approved products containing result in: an annual effect on the dronabinol in an oral solution not Executive Order 13175, Consultation economy of $100,000,000 or more; a authorized by, or in violation of, the and Coordination With Indian Tribal major increase in costs or prices for CSA or its implementing regulations, is Governments consumers, individual industries, unlawful, and may subject the person to This rule does not have tribal Federal, State, or local government administrative, civil, and/or criminal implications warranting the application agencies, or geographic regions; or sanctions. of Executive Order 13175. It does not significant adverse effects on

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competition, employment, investment, Reporting and recordkeeping ■ 2. In § 1308.12, add paragraph (f)(2) to productivity, innovation, or on the requirements. read as follows: ability of U.S.-based companies to compete with foreign based companies For the reasons set out above, the DEA § 1308.12 Schedule II. amends 21 CFR part 1308 as follows: in domestic and export markets. * * * * * However, pursuant to the CRA, the DEA PART 1308—SCHEDULES OF (f) * * * has submitted a copy of this interim CONTROLLED SUBSTANCES final rule to both Houses of Congress and to the Comptroller General. ■ 1. The authority citation for 21 CFR List of Subjects in 21 CFR Part 1308 part 1308 continues to read as follows: Administrative practice and Authority: 21 U.S.C. 811, 812, 871(b), procedure, Drug traffic control, unless otherwise noted.

(2) Dronabinol [(-)-delta-9-trans tetrahydrocannabinol] in an oral solution in a drug product approved for marketing by the U.S. Food and Drug Administration ...... (7365)

* * * * * MacDonald, Bridge Management end of the effective period of this Dated: March 20, 2017. Specialist, Coast Guard; telephone 504– temporary deviation. This deviation Chuck Rosenberg, 671–2128, email Giselle.T.MacDonald@ from the operating regulations is uscg.mil. authorized under 33 CFR 117.35. Acting Administrator. [FR Doc. 2017–05809 Filed 3–22–17; 8:45 am] SUPPLEMENTARY INFORMATION: The Dated: March 17, 2017. BILLING CODE 4410–09–P Burlington Northern Santa Fe Railroad Eric A. Washburn, Company requested a temporary Bridge Administrator, Eighth Coast Guard deviation from the operating schedule District. DEPARTMENT OF HOMELAND for the swing span drawbridge across [FR Doc. 2017–05810 Filed 3–22–17; 8:45 am] SECURITY Des Allemands Bayou, mile 14.0, at Des BILLING CODE 9110–04–P Allemands, St. Charles and Lafourche Coast Guard Parishes, Louisiana. The deviation was requested to install two open-deck DEPARTMENT OF VETERANS 33 CFR Part 117 spans, one on each side of the existing AFFAIRS swing span, to increase the reliability of [Docket No. USCG–2017–0100] bridge opening and closing operations. 38 CFR Part 17 The draw currently operates under 33 Drawbridge Operation Regulation; Des RIN 2900–AP73 Allemands Bayou, Des Allemands, LA CFR 117.440(b). The draw of the Burlington Northern Santa Fe Railroad Release of VA Records Relating to HIV AGENCY: Coast Guard, DHS. Bridge, Mile 14.0, shall open on signal ACTION: Notice of deviation from Monday through Friday from 7 a.m. to AGENCY: Department of Veterans Affairs. drawbridge regulation. 3 p.m. At all other times the draw shall ACTION: Final rule. open on signal if at least 4 hours notice SUMMARY: The Coast Guard has issued a is given. SUMMARY: The Department of Veterans temporary deviation from the operating For purposes of this deviation, the Affairs (VA) is amending its medical schedule that governs the Burlington bridge will remain closed to navigation regulations governing the release of VA Northern Santa Fe Railroad swing span for two separate dates, 30 hours each, medical records. Specifically, VA is drawbridge across Des Allemands from 6 a.m. April 20, 2017 through 12 eliminating the restriction on sharing a Bayou, mile 14.0, at Des Allemands, St. noon, April 21, 2017 and from 6 a.m., negative test result for the human Charles and Lafourche Parishes, April 27, 2017 through 12 noon, April immunodeficiency virus (HIV) with Louisiana. The deviation is necessary to 28, 2017. During this deviation, vessels veterans’ outside providers. HIV testing install two open-deck spans for will not be allowed to pass through the is a common practice today in increased reliability of bridge bridge. The bridge has a vertical healthcare and the stigma of testing that operations. This deviation allows the clearance of 3 feet above mean high may have been seen in the 1980s when bridge to remain in the closed-to- water in the closed-to-navigation HIV was first discovered is no longer navigation position for two (2) separate, position and unlimited in the open-to- prevalent. Continuing to protect two-day periods. navigation position. Navigation on the negative HIV tests causes delays and an DATES: This deviation is effective from waterway consists of tugs with tows, unnecessary burden on veterans when 6 a.m. on April 20, 2017 through 12 fishing vessels and recreational craft. VA tries to share electronic medical noon on April 28, 2017. The Coast Guard will inform the users information with the veterans’ outside ADDRESSES: The docket for this of the waterway through our Local and providers through electronic health deviation, [USCG–2017–0100] is Broadcast Notices to Mariners of the information exchanges. For this same available at http://www.regulations.gov. change in operating schedule for the reason, VA will also eliminate Type the docket number in the bridge. The bridge will not be able to restrictions on negative test results of ‘‘SEARCH’’ box and click ‘‘SEARCH’’. open for emergencies and there is no sickle cell anemia. This final rule Click on Open Docket Folder on the line immediate alternate route for vessels to eliminates the current barriers to associated with this deviation. pass. electronic medical information FOR FURTHER INFORMATION CONTACT: If In accordance with 33 CFR 117.35(e), exchange. you have questions on this temporary the drawbridge must return to its regular DATES: This final rule is effective April deviation, call or email Giselle operating schedule immediately at the 24, 2017.

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