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Federal Register / Vol. 85, No. 150 / Tuesday, August 4, 2020 / Notices 47217

DEPARTMENT OF HEALTH AND DATES: Comments due within 60 days of doing business in their state to locate HUMAN SERVICES publication. In compliance with the obligors’ accounts. OCSE operates the requirements of Section 3506(c)(2)(A) of MSFIDM program through the Federal Administration for Children and the Paperwork Reduction Act of 1995, Parent Locator Service (FPLS) and Families ACF is soliciting public comment on the facilitates the required data match [OMB #0970–0196] specific aspects of the information between state child support agencies collection described above. and financial institutions doing Proposed Information Collection ADDRESSES: Copies of the proposed business in multiple states. State child Activity; Multistate Financial Institution collection of information can be support enforcement agencies use the Data Match With Federally Assisted obtained and comments may be data match outcomes to fulfill a State Transmitted Levy forwarded by emailing infocollection@ statutory requirement to seize an acf.hhs.gov. Alternatively, copies can AGENCY: Office of Child Support obligor’s assets to satisfy overdue child Enforcement, Administration for also be obtained by writing to the support payments. Administration for Children and Children and Families, HHS. OCSE also operates FAST Levy, Families, Office of Planning, Research, ACTION: Request for Public Comment. and Evaluation (OPRE), 330 C Street which is an automated application within the FPLS to exchange electronic SUMMARY: The Administration for SW, Washington, DC 20201, Attn: ACF lien/levy information securely and Children and Families’ (ACF) Office of Reports Clearance Officer. All requests, efficiently. State child support Child Support Enforcement (OCSE) is emailed or written, should be identified requesting a 3-year extension of the by the title of the information collection. enforcement agencies and multistate financial institutions (MSFIs) use FAST currently approved Multistate Financial SUPPLEMENTARY INFORMATION: Institution Data Match with Federally Description: State child support Levy to seize financial assets more Assisted State Transmitted Levy enforcement agencies are statutorily quickly and efficiently. (MSFIDM/FAST Levy) (current OMB required to enter into data matching Respondents: MSFIs and state child approval expires 1/31/2021). agreements with financial institutions support agencies.

ANNUAL BURDEN ESTIMATES

Annual Average Annual number of annual Annual Instrument number of responses per burden hours burden hours respondents respondent per response

Financial Data Match Record Specifications: Match File Upload/Download: Portal Users ...... 184 4 .083 61.1 Election Form ...... 15 1 .5 7.5 FAST Levy Response Withhold Record Specifications: Financial Institutions 1 1 1,716 1,716.0 FAST Levy Request Withhold Record Specifications: State Child Support Agencies ...... 1 1 1,610 1,610.0 Estimated Total Annual Burden Hours: 3,394.6.

Comments: The Department 666(a)(17)(A), 42 U.S.C. 652(a)(7), and 45 DEPARTMENT OF HEALTH AND specifically requests comments on (a) CFR 303.7(a)(5). HUMAN SERVICES whether the proposed collection of John M. Sweet Jr., information is necessary for the proper Food and Drug Administration ACF/OPRE Certifying Officer. performance of the functions of the [Docket No. FDA–2020–N–1680] agency, including whether the [FR Doc. 2020–16891 Filed 8–3–20; 8:45 am] information shall have practical utility; BILLING CODE 4184–41–P International Drug Scheduling; (b) the accuracy of the agency’s estimate Convention on Psychotropic of the burden of the proposed collection Substances; Single Convention on of information; (c) the quality, utility, Narcotic Drugs; Isotonitazene; MDMB- and clarity of the information to be 4en-PINACA; CUMYL-PEGACLONE; collected; and (d) ways to minimize the Flubromazolam; Clonazolam; burden of the collection of information Diclazepam; 3-MeO-PCP; ; 2-MEO-DIPHENIDINE; 5- on respondents, including through the MEO-DALT; and 3- use of automated collection techniques FLUOROPHENMETRAZINE (3-FPM); or other forms of information Request for Comments technology. Consideration will be given to comments and suggestions submitted AGENCY: Food and Drug Administration, within 60 days of this publication. HHS. Authority: 42 U.S.C. 652(l), 42 U.S.C. ACTION: Notice; request for comments. 666(a)(2) and (c)(1)(G)(ii), 42 U.S.C. SUMMARY: The Food and Drug Administration (FDA or the Agency) is requesting interested persons to submit comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling

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changes on availability for medical use Management Staff (HFA–305), Food and Docket: For access to the docket to of 11 drug substances. These comments Drug Administration, 5630 Fishers read background documents or the will be considered in preparing a Lane, Rm. 1061, Rockville, MD 20852. electronic and written/paper comments response from the United States to the • For written/paper comments received, go to https:// World Health Organization (WHO) submitted to the Dockets Management www.regulations.gov and insert the regarding the abuse liability and Staff, FDA will post your comment, as docket number, found in brackets in the diversion of these drugs. WHO will use well as any attachments, except for heading of this document, into the this information to consider whether to information submitted, marked and ‘‘Search’’ box and follow the prompts recommend that certain international identified, as confidential, if submitted and/or go to the Dockets Management restrictions be placed on these drug as detailed in ‘‘Instructions.’’ Staff, 5630 Fishers Lane, Rm. 1061, substances. This notice requesting Instructions: All submissions received Rockville, MD 20852, 240–402–7500. comments is required by the Controlled must include the Docket No. FDA– FOR FURTHER INFORMATION CONTACT: Substances Act (CSA). 2020–N–1680 for ‘‘International Drug James R. Hunter, Center for Drug DATES: Submit either electronic or Scheduling; Convention on Evaluation and Research, Controlled written comments by August 28, 2020. Psychotropic Substances; Single Substance Staff, Food and Drug ADDRESSES: You may submit comments Convention on Narcotic Drugs; Administration, 10903 New Hampshire as follows. Please note that late, Isotonitazene; MDMB-4en-PINACA; Ave., Bldg. 51, Rm. 5150, Silver Spring, untimely filed comments will not be CUMYL-PEGACLONE; Flubromazolam; MD 20993–0002, 301–796–3156, considered. Electronic comments must Clonazolam; Diclazepam; 3-MeO-PCP; [email protected]. be submitted on or before August 28, DIPHENIDINE; 2-MEO-DIPHENIDINE; SUPPLEMENTARY INFORMATION: 2020. The https://www.regulations.gov 5-MEO-DALT; and 3- I. Background electronic filing system will accept FLUOROPHENMETRAZINE (3-FPM); comments until 11:59 p.m. Eastern Time Request for Comments.’’ Received The United States is a party to the at the end of August 28, 2020. comments, those filed in a timely 1971 Convention on Psychotropic Comments received by mail/hand manner (see ADDRESSES), will be placed Substances (Psychotropic Convention). delivery/courier (for written/paper in the docket and, except for those Article 2 of the Psychotropic submissions) will be considered timely submitted as ‘‘Confidential Convention provides that if a party to if they are postmarked or the delivery Submissions,’’ publicly viewable at the convention or WHO has information service acceptance receipt is on or https://www.regulations.gov or at the about a substance, which in its opinion before that date. Dockets Management Staff between 9 may require international control or a.m. and 4 p.m., Monday through change in such control, it shall so notify Electronic Submissions Friday, 240–402–7500. the Secretary-General of the United Submit electronic comments in the • Confidential Submissions—To Nations (the U.N. Secretary-General) following way: submit a comment with confidential and provide the U.N. Secretary-General • Federal eRulemaking Portal: information that you do not wish to be with information in support of its https://www.regulations.gov. Follow the made publicly available, submit your opinion. instructions for submitting comments. comments only as a written/paper Paragraph (d)(2)(A) of the CSA (21 Comments submitted electronically, submission. You should submit two U.S.C. 811) (Title II of the including attachments, to https:// copies total. One copy will include the Comprehensive Drug Abuse Prevention www.regulations.gov will be posted to information you claim to be confidential and Control Act of 1970) provides that the docket unchanged. Because your with a heading or cover note that states when WHO notifies the United States comment will be made public, you are ‘‘THIS DOCUMENT CONTAINS under Article 2 of the Psychotropic solely responsible for ensuring that your CONFIDENTIAL INFORMATION.’’ The Convention that it has information that comment does not include any Agency will review this copy, including may justify adding a drug or other confidential information that you or a the claimed confidential information, in substances to one of the schedules of the third party may not wish to be posted, its consideration of comments. The Psychotropic Convention, transferring a such as medical information, your or second copy, which will have the drug or substance from one schedule to anyone else’s Social Security number, or claimed confidential information another, or deleting it from the confidential business information, such redacted/blacked out, will be available schedules, the Secretary of State must as a manufacturing process. Please note for public viewing and posted on transmit the notice to the Secretary of that if you include your name, contact https://www.regulations.gov. Submit Health and Human Services (Secretary information, or other information that both copies to the Dockets Management of HHS). The Secretary of HHS must identifies you in the body of your Staff. If you do not wish your name and then publish the notice in the Federal comments, that information will be contact information to be made publicly Register and provide opportunity for posted on https://www.regulations.gov. available, you can provide this interested persons to submit comments • If you want to submit a comment information on the cover sheet and not that will be considered by HHS in its with confidential information that you in the body of your comments and you preparation of the scientific and medical do not wish to be made available to the must identify this information as evaluations of the drug or substance. public, submit the comment as a ‘‘confidential.’’ Any information marked II. WHO Notification written/paper submission and in the as ‘‘confidential’’ will not be disclosed manner detailed (see ‘‘Written/Paper except in accordance with 21 CFR 10.20 The Secretary of HHS received the Submissions’’ and ‘‘Instructions’’). and other applicable disclosure law. For following notice from WHO (non- more information about FDA’s posting relevant text removed): Written/Paper Submissions of comments to public dockets, see 80 Ref.: C.L.22.2020 Submit written/paper submissions as FR 56469, September 18, 2015, or access The World Health Organization (WHO) follows: the information at: https:// presents its compliments to Member States • Mail/Hand delivery/Courier (for www.govinfo.gov/content/pkg/FR-2015- and Associate Members and in reference to written/paper submissions): Dockets 09-18/pdf/2015-23389.pdf. C.L.14.2019 has the pleasure of informing

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that the 43rd Expert Committee on Drug and are not currently under Synthetic have been Dependence (ECDD) will meet from 12 to 16 international control. Information was marketed under the guise of ‘‘herbal October 2020 in Geneva, Switzerland. In the brought to WHO’s attention that these incense,’’ and promoted by drug event that the meeting should be held traffickers as legal alternatives to virtually due to exceptional circumstances, substances are clandestinely corresponding arrangements will be made. manufactured, of especially serious risk marijuana. According to the NFLIS Given that ECDD meetings are of a closed to public health and society, and of no database, MDMB-4en-PINACA was first nature, this letter serves to notify Member recognized therapeutic use by any Party. encountered in the United States in States of the substances under review at the January 2019. There have been 1,436 43rd ECDD, which are in the Annex I for CRITICAL REVIEW encounters of MDMB-4en-PINACA in reference. the United States (as of July 6, 2020). WHO is mandated by the 1961 and 1971 Synthetic ...... 1. Isotonitazene MDMB-4en-PINACA has also been International Drug Control Conventions to Synthetic 2. MDMB-4en-PINACA encountered mixed with opioids make recommendations to the UN Secretary- Receptor . 3. CUMYL-PEGALONE General on the need for and level of ...... 4. Flubromazolam including and , with international control of psychoactive 5. Clonazolam some incidents resulting in violent substances based on the advice of its 6. Diclazepam behaviors, tachycardia, and independent scientific advisory body, the -type sub- 7. 3-MeO-PCP hypertension. There are no commercial ECDD. To assess the appropriate control of a stances. 8. DIPHENIDINE 9. 2-MEO-DIPHENIDINE or approved medical uses for MDMB- psychoactive substance, the ECDD convenes ...... 10. 5-MEO-SALT 4en-PINACA and MDMB-4en-PINACA annually to review the potential of this Synthetic ...... 11. 3- is not a controlled substance under the substance to cause dependence, abuse and FLUROPHENMETRA- CSA. harm to health, as well as any therapeutic ZINE (3-FPM) applications. In order to perform this review CUMYL-PEGACLONE is a synthetic and make scientific and evidence-based cannabinoid that has been sold online FDA has verified the website and used to mimic the biological effects decisions, the ECDD conducts medical, addresses contained in the WHO notice, scientific, and public health evaluations of of THC, the main psychoactive as of the date this document publishes the selected psychoactive substances using constituent in marijuana. Research and the best available information. in the Federal Register, but websites are clinical reports have demonstrated that Although the meetings are of a closed subject to change over time. Access to are applied onto nature, Member States are invited to view the WHO questionnaire can be plant material so that the material may contribute to the ECDD review process by found at https://www.who.int/teams/ be smoked as users attempt to obtain a joining the 43rd ECDD Open Session on 12 health-product-and-policy-standards/ October 2020. The Open Session will allow euphoric and psychoactive ‘‘high’’. controlled-substances/ecdd-member- Synthetic cannabinoids have been interested parties to present information state-questionnaire. concerning substances under review to the marketed under the guise of ‘‘herbal Expert Committee. Registration information III. Substances Under WHO Review incense,’’ and promoted by drug will be made available on the ECDD website: traffickers as legal alternatives to https://www.who.int/medicines/access/ Isotonitazene (chemical name: N,N- marijuana. In vitro studies demonstrate controlled-substances/en/. diethyl-2-(2-(4 isopropoxybenzyl)-5- that CUMYL-PEGALCONE binds to and As in the past and in line with the nitro-1H-benzimidazol-1-yl)ethan-1- activates the cannabinoid one receptor. publication ‘‘Guidance on the WHO review of ) is a potent synthetic that CUMYL-PEGALCONE has not been psychoactive substances for international is abused similar to other synthetic control’’ (EB126/2010/REC1, Annex 6),1 encountered within the United States opioids. Its use has resulted in adverse according to the NFLIS database (as of Member States can also contribute to the health effects, including positively ECDD review process by providing accurate July 6, 2020). There are no commercial information concerning the substances under identified in 49 death investigation or approved medical uses for CUMYL- review in advance of the meeting. For this cases in the United States between PEGALCONE and is not a controlled purpose, a questionnaire will be sent to August 2019 and April 2020. Law substance under the CSA. Member States to gather country information enforcement data indicate that Flubromazolam, clonazolam, and on the legitimate use, harmful use, status of isotonitazene has appeared in the diclazepam belong to a class of national control and potential impact of United States’ illicit drug market. international control for each substance substances known as benzodiazepines. According to the National Forensic Benzodiazepines produce central under evaluation. Laboratory Information System (NFLIS) In addition to the questionnaire, Member nervous system depression and are States are also encouraged to provide any database, there have been 53 encounters commonly used to treat insomnia, additional relevant information (unpublished of isotonitazene in the United States (as anxiety, and seizure disorders. or published) on substances to be reviewed of June 2020). There are no commercial Flubromazolam is a triazole analogue of by the 43rd ECDD by emailing or approved medical uses for the designer , [email protected] with the subject isotonitazene. On June 18, 2020, the flubromazepam. Flubromazolam can be ‘‘Ref: C.L.22.2020’’. Drug Enforcement Administration purchased on the internet and is used as The World Health Organization takes this issued a notice of intent to temporarily a recreational substance in the United opportunity to renew to Member States and control isotonitazene as a schedule I Associate Members the assurance of its States. Flubromazolam has been highest consideration. substance under the CSA. identified in an increasing number of MDMB-4en-PINACA is a synthetic law enforcement seizures and has been GENEVA, 23 June 2020 cannabinoid that has been sold online associated with an increasing number of 1 https://apps.who.int/gb/ebwha/pdf_files/ and used to mimic the biological effects deaths. It is abused by a EB126-REC1/B126_REC1-en.pdf#page=58. of (THC), the broad range of groups including youths, Annex I main psychoactive constituent in young adults, and older adults. marijuana. Research and clinical reports Clonazolam has been involved in an 43nd Expert Committee on Drug have demonstrated that synthetic increasing number of drug seizure Dependence (ECDD), 12–16 October cannabinoids are applied onto plant events as well as drug overdose deaths, 2020, Substances for Review material so that the material may be alone and in combination with . The substances listed below have smoked as users attempt to obtain a Diclazepam is a designer never been formally reviewed by WHO euphoric and psychoactive ‘‘high’’. benzodiazepine sold on the internet and

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most often found as a liquid solution, United States. 2-MeO-DIPHENIDINE is could impose certain recordkeeping but it may be sold as a powder, tablet, encountered by law enforcement in drug requirements on them. blotter paper, or pellet. In 2018, seizure reports. There is no approved Although FDA is, through this notice, flubromazolam, clonazolam, and medical use for 2-MeO-DIPHENIDINE in requesting comments from interested dicalazepam were all identified by law the United States and 2-MeO- persons, which will be considered by enforcement in driving under the DIPHENIDINE is not a controlled HHS when it prepares an evaluation of influence of drugs cases in the United substance under the CSA. these drug substances, HHS will not States. Flubromazolam, clonazolam, and 5-MeO-DALT (chemical name: N,N- now make any recommendations to diclazepam are not approved for Diallyl-5-methoxytryptamine) is a WHO regarding whether any of these medical use in the United States and are hallucinogen and is an drugs should be subjected to not controlled substances under the of the (5–HT) 5–HT2A international controls. Instead, HHS will CSA. receptor. 5-MeO-DALT appears to defer such consideration until WHO has 3-MeO-PCP (3- produce hallucinogenic effects similar made official recommendations to the methoxyphencyclidine; chemical name: to other tryptamine and Commission on Narcotic Drugs, which 1-(1-(3- fully substituted for 2,5-dimethoxy-4- are expected to be made in late-2020. methoxyphenyl)cyclohexyl)) methylamphetamine (DOM) in DOM- Any HHS position regarding is a novel N-methyl-D-aspartate (NMDA) trained rats. 5-MeO-DALT is an international control of these drug receptor antagonist with structural and analogue of the Schedule I controlled substances will be preceded by another biochemical similarities to substance 5methoxy-N,N- Federal Register notice soliciting public phencyclcycidine (PCP) and other (5-MeO-DiPT). 5- comments, as required by paragraph . 3-MeO-PCP is MeO-DALT has been encountered by (d)(2)(B) of the CSA. classified as an law enforcement in drug seizure reports. and produces dissociative 5-MeO-DALT is not approved for Dated: July 29, 2020. and hallucinogenic effects. Use of this medical use in the United States and is Lowell J. Schiller, substance is associated with not controlled under the CSA. Principal Associate Commissioner for Policy. intoxication and published case reports 3-FLUOROPHENMETRAZINE (3- [FR Doc. 2020–16905 Filed 8–3–20; 8:45 am] of both fatal and non-fatal overdose. 3- FPM) (chemical name: 1-(3- BILLING CODE 4164–01–P MeO-PCP is encountered by law fluorophenyl)-2-(methylamino)propan- enforcement in drug seizure reports. 3- 1-one) shares substantial chemical MeO-PCP is an analogue of the structural similarity to , a DEPARTMENT OF HEALTH AND Schedule II hallucinogen PCP. There is Schedule II controlled substance that HUMAN SERVICES no approved medical use for 3-MeO- was prescribed as an appetite PCP in the United States. 3-MeO-PCP is suppressant before being withdrawn Food and Drug Administration not a controlled substance under the from the pharmaceutical drug market in [Docket No. FDA–2019–N–3560] CSA. If intended for human the United States because of its abuse consumption, 3-MeO-PCP may be potential. 3-FPM, which is similar to Biosimilar User Fee Rates for Fiscal treated as a ‘‘controlled substance phenmetrazine and other stimulant Year 2021 analogue’’ under the CSA pursuant to 21 drugs of abuse, increases extracellular AGENCY: U.S.C 802(32) (A) and 813. concentrations of the neurotransmitter Food and Drug Administration, DIPHENIDINE (chemical name: 1-(1,2- by inhibiting the uptake of HHS. diphenylethyl) piperidine) is a non- this neurotransmitter at the dopamine ACTION: Notice. competitive NMDA receptor antagonist transporter. Elevated extracellular SUMMARY: classified as a diarylethylamine and dopamine concentrations have been The Food and Drug produces dissociative anesthetic and implicated in the Administration (FDA) is announcing the hallucinogenic effects. It was originally of stimulant drugs of abuse. There is no rates for biosimilar user fees for fiscal synthesized in the 1920s, but reports of approved medical use for 3-FPM in the year (FY) 2021. The Federal Food, Drug, abuse started in the last decade. Use of United States and 3-FPM is not a and Cosmetic Act (FD&C Act), as this substance is associated with controlled substance under the CSA. amended by the Biosimilar User Fee intoxication and published case reports Amendments of 2017 (BsUFA II), IV. Opportunity To Submit Domestic of both fatal and non-fatal overdose authorizes FDA to assess and collect Information outside of the United States. user fees for certain activities in DIPHENIDINE is encountered by law As required by paragraph (d)(2)(A) of connection with biosimilar biological enforcement in drug seizure reports. the CSA, FDA, on behalf of HHS, invites product development; review of certain DIPHENIDINE is not approved for interested persons to submit comments applications for approval of biosimilar medical use in the United States and is regarding the 11 drug substances. Any biological products; and each biosimilar not a controlled substance under the comments received will be considered biological product approved in a CSA. by HHS when it prepares a scientific biosimilar biological product 2-MeO-DIPHENIDINE (2-methoxy- and medical evaluation for drug application. BsUFA II directs FDA to diphenidine, ) is a substances that is responsive to the establish, before the beginning of each non-competitive NMDA receptor WHO Questionnaire for these drug fiscal year, the amount of initial and antagonist classified as a substances. HHS will forward such annual biosimilar biological product diarylethylamine and produces evaluation of these drug substances to development (BPD) fees, the dissociative anesthetic and WHO, for WHO’s consideration in reactivation fee, and the biosimilar hallucinogenic effects that may produce deciding whether to recommend biological product application and effects similar to high doses of international control/decontrol of any of program fees for such year. These fees . Use of this these drug substances. Such control apply to the period from October 1, substance is associated with could limit, among other things, the 2020, through September 30, 2021. intoxication and non-fatal overdose in manufacture and distribution (import/ FOR FURTHER INFORMATION CONTACT: published case reports outside the export) of these drug substances and Andrew Bank, Office of Financial

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