sign in sign up
<<
Home , Arylcyclohexylamine, Clonazolam, Diclazepam, Flubromazepam, Flubromazolam, Hallucinogen

Federal Register / Vol. 86, No. 31 / Thursday, February 18, 2021 / Notices 10103

behaviors, , and commonly used to treat insomnia, Dated: February 12, 2021. hypertension. There are no commercial , and seizure disorders. Lauren K. Roth, or approved medical uses for MDMB- is a triazole analogue of Acting Principal Associate Commissioner for 4en-PINACA and it is not a controlled the designer , Policy. substance under the CSA. As such, . Flubromazolam can be [FR Doc. 2021–03268 Filed 2–17–21; 8:45 am] additional permanent controls will be purchased on the internet and is used as necessary to fulfill U.S. obligations if a recreational substance in the United BILLING CODE 4164–01–P MDMB-4en-PINACA is controlled under States. Flubromazolam has been Schedule II of the 1971 Convention. identified in an increasing number of DEPARTMENT OF HEALTH AND 3-Methoxyphencyclidine; chemical law enforcement seizures and has been HUMAN SERVICES name: 1-(1-(3-methoxyphenyl) associated with an increasing number of cyclohexyl)) is a novel N- overdose deaths. According to the Centers for Disease Control and methyl-D-aspartate (NMDA) NFLIS database, in 2020 there were Prevention antagonist with structural and 1,446 encounters (as of biochemical similarities to December 2020). It is abused by a broad Notice of Closed Meeting phencyclcycidine (PCP) and other range of groups including youths, young . 3- adults, and older adults. Clonazolam Pursuant to section 10(d) of the Methoxyphencyclidine is classified as has been involved in an increasing Federal Advisory Committee Act, as an and produces number of drug seizure events as well amended, notice is hereby given of the and as deaths, alone and in following meeting. hallucinogenic effects. Use of this combination with . As such, the substance is associated with NFLIS database reported 249 encounters The meeting will be closed to the intoxication and published case reports in 2020 (as of December 2020). public in accordance with the of both fatal and non-fatal overdose. 3- is a designer provisions set forth in sections Methoxyphencyclidine is encountered benzodiazepine sold on the internet and 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., by law enforcement in drug seizure most often found as a liquid solution, as amended, and the Determination of reports. 3-Methoxyphencyclidine is an but it may be sold as a powder, tablet, the Director, Strategic Business analogue of the Schedule II blotter paper, or pellet. In 2020, the Initiatives Unit, Office of the Chief PCP. There is no approved NFLIS database reported 113 encounters Operating Officer, CDC, pursuant to medical use for 3- of diclazepam (as of December 2020). In Public Law 92–463. The grant Methoxyphencyclidine in the United 2018, flubromazolam, clonazolam, and applications and the discussions could States and is not a controlled substance dicalazepam were all identified by law disclose confidential trade secrets or under the CSA. If intended for human enforcement in driving under the commercial property such as patentable consumption, 3-Methoxyphencyclidine influence of cases in the United material, and personal information may be treated as a ‘‘controlled States. Flubromazolam, clonazolam, and concerning individuals associated with substance analogue’’ under the CSA diclazepam are not approved for the grant applications, the disclosure of pursuant to 21 U.S.C. 802(32)(A) and medical use in the United States and are which would constitute a clearly 813. As such, additional permanent not controlled substances under the unwarranted invasion of personal controls will be necessary to fulfill U.S. CSA. As such, additional permanent privacy. obligations if 3-Methoxyphencyclidine controls will be necessary to fulfill U.S. Name of Committee: Disease, is controlled under Schedule II of the obligations if flubromazolam, Disability, and Injury Prevention and 1971 Convention. clonazolam, and dicalazepam are Control Special Emphasis Panel (SEP)— (chemical name: 1-(1,2- controlled under Schedule IV of the SIP21–008, Examining Approaches to diphenylethyl) piperidine) is a non- 1971 Convention. Improve Care and Management of competitive NMDA FDA, on behalf of the Secretary of People with Lupus. classified as a diarylethylamine and HHS, invites interested persons to produces dissociative anesthetic and submit comments on the notifications Date: May 13, 2021. hallucinogenic effects. It was originally from the United Nations concerning Time: 11:00 a.m.–6:00 p.m., EDT. synthesized in the 1920s but reports of these drug substances. FDA, in Place: Teleconference. abuse started in the last decade. Use of cooperation with the National Institute this substance is associated with on Drug Abuse, will consider the Agenda: To review and evaluate grant intoxication and published case reports comments on behalf of HHS in applications. of both fatal and non-fatal overdose evaluating the WHO scheduling FOR FURTHER INFORMATION CONTACT: Jaya outside of the United States. recommendations. Then, under section Raman, Ph.D., Scientific Review Officer, Diphenidine is encountered by law 201(d)(2)(B) of the CSA, HHS will National Center for Chronic Disease enforcement in drug seizure reports. recommend to the Secretary of State Prevention and Health Promotion, CDC, Diphenidine is not approved for what position the United States should 4770 Buford Highway, Mailstop S107–8, medical use in the United States and is take when voting on the Atlanta, Georgia 30341, Telephone (770) not a controlled substance under the recommendations for control of 488–6511, [email protected]. CSA. As such, additional permanent substances under the 1971 Convention controls will be necessary to fulfill U.S. at the CND meeting in April 2021. The Director, Strategic Business obligations if diphenidine is controlled Comments regarding the WHO Initiatives Unit, Office of the Chief under Schedule II of the 1971 recommendations for control of Operating Officer, Centers for Disease Convention. isotonitazene under the 1961 Single Control and Prevention, has been Flubromazolam, clonazolam, and Convention will also be forwarded to delegated the authority to sign Federal diclazepam belong to a class of the relevant Agencies for consideration Register notices pertaining to substances known as . in developing the U.S. position announcements of meetings and other Benzodiazepines produce central regarding substances at the committee management activities, for and are CND meeting. both the Centers for Disease Control and

VerDate Sep<11>2014 17:47 Feb 17, 2021 Jkt 253001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\18FEN1.SGM 18FEN1 jbell on DSKJLSW7X2PROD with NOTICES 10104 Federal Register / Vol. 86, No. 31 / Thursday, February 18, 2021 / Notices

Prevention and the Agency for Toxic Certification To Accompany Drug, FDA 3674, that all applicable Substances and Disease Registry. Biological Product, and Device requirements of section 402(j) of the Applications or Submissions (Form PHS Act have been met. Where Kalwant Smagh, FDA 3674) available, such certification must Director, Strategic Business Initiatives Unit, include the appropriate National OMB Control Number 0910–0616— Office of the Chief Operating Officer, Centers (NCT) numbers that are for Disease Control and Prevention. Extension assigned upon submission of required [FR Doc. 2021–03234 Filed 2–17–21; 8:45 am] The information required under information to the NIH databank at BILLING CODE 4163–18–P section 402(j)(5)(B) of the Public Health https://clinicaltrials.gov/. Service Act (PHS Act) (42 U.S.C. The proposed extension of the 282(j)(5)(B)) is submitted in the form of collection of information is necessary to DEPARTMENT OF HEALTH AND a certification, Form FDA 3674, which satisfy the previously mentioned HUMAN SERVICES accompanies applications and statutory requirement. The importance submissions currently submitted to FDA Food and Drug Administration of obtaining these data relates to and already approved by OMB. The adherence to the legal requirements for OMB control numbers and expiration submissions to the clinical trials registry [Docket No. FDA–2011–N–0275] dates for those applications and and results data bank and ensuring that submissions are: 21 CFR parts 312 and individuals and organizations Agency Information Collection 314 (human drugs), OMB control submitting applications or reports to Activities; Submission for Office of number 0910–0014, expiring March 31, FDA under the listed provisions of the Management and Budget Review; 2022, and OMB control number 0910– FD&C Act or the PHS Act adhere to the Comment Request; Certification To 0001, expiring March 31, 2021; 21 CFR appropriate legal and regulatory Accompany Drug, Biological Product, parts 312 and 601 (biological products), requirements for certifying to having and Device Applications or OMB control number 0910–0014, complied with those requirements. The Submissions expiring March 31, 2022, and OMB failure to submit the certification control number 0910–0338, expiring AGENCY: Food and Drug Administration, required by section 402(j)(5)(B) of the February 28, 2023; 21 CFR parts 807 and HHS. PHS Act, and the knowing submission 814 (devices), OMB control number of a false certification, are both ACTION: Notice. 0910–0120, expiring June 30, 2020, and prohibited acts under section 301 of the OMB control number 0910–0231, FD&C Act (21 U.S.C. 331). Violations are SUMMARY: The Food and Drug expiring March 31, 2023. subject to civil money penalties. Form Administration (FDA) is announcing Title VIII of the Food and Drug FDA 3674 provides a convenient that a proposed collection of Administration Amendments Act of mechanism for sponsors/applicants/ information has been submitted to the 2007 (FDAAA) (. L. 110–85) submitters to satisfy the certification Office of Management and Budget amended the PHS Act by adding section requirements of the statutory provision. (OMB) for review and clearance under 402(j). The provisions broadened the To assist sponsors/applicants/ the Paperwork Reduction Act of 1995. scope of clinical trials subject to submitters in understanding the submitting information and required DATES: Submit written comments statutory requirements associated with (including recommendations) on the additional information to be submitted Form FDA 3674, we have provided a collection of information by March 22, to the clinical trials databank (https:// guidance available at: https:// 2021. clinicaltrials.gov/) (FDA has verified the www.fda.gov/RegulatoryInformation/ website address, but FDA is not Guidances/ucm125335.htm. This ADDRESSES: To ensure that comments on responsible for any subsequent changes guidance recommends the applications the information collection are received, to the website after this document and submissions FDA considers should OMB recommends that written publishes in the Federal Register) be accompanied by the certification comments be submitted to https:// previously established by the National form, Form FDA 3674. The applications www.reginfo.gov/public/do/PRAMain. Institutes of Health (NIH)/National and submissions identified in the Find this particular information Library of Medicine. This includes guidance are reflected in the burden collection by selecting ‘‘Currently under expanded information on applicable analysis. FDA last updated this Review—Open for Public Comments’’ or clinical trials and summary information guidance in 2017. by using the search function. The OMB on the results of certain clinical trials. Investigational New Drug control number for this information The provisions include responsibilities Applications. FDA’s Center for Drug collection is 0910–0616. Also include for FDA as well as several amendments Evaluation and Research (CDER) the FDA docket number found in to the Federal Food, Drug, and Cosmetic received 1,661 investigational new drug brackets in the heading of this Act (FD&C Act). applications (INDs) and 11,328 clinical document. One provision, section 402(j)(5)(B) of protocol IND amendments in calendar the PHS Act, requires that a certification year (CY) 2019. CDER anticipates that FOR FURTHER INFORMATION CONTACT: accompany human drug, biological, and IND and clinical protocol amendment JonnaLynn Capezzuto, Office of device product submissions made to submission rates will remain at or near Operations, Food and Drug FDA. Specifically, at the time of this level in the near future. Administration, Three White Flint submission of an application under FDA’s Center for Biologics Evaluation North, 10A–12M, 11601 Landsdown St., sections 505, 515, or 520(m) of the and Research (CBER) received 639 new North Bethesda, MD 20852, 301–796– FD&C Act (21 U.S.C. 355, 360e, or INDs and 581 clinical protocol IND 3794, [email protected]. 360j(m)), or under section 351 of the amendments in CY 2019. CBER SUPPLEMENTARY INFORMATION: In PHS Act (42 U.S.C. 262), or submission anticipates that IND and clinical compliance with 44 U.S.C. 3507, FDA of a report under section 510(k) of the protocol amendment submission rates has submitted the following proposed FD&C Act (21 U.S.C. 360(k)), such will remain at or near this level in the collection of information to OMB for application or submission must be near future. The estimated total number review and clearance. accompanied by a certification, Form of submissions (new INDs and new

VerDate Sep<11>2014 17:47 Feb 17, 2021 Jkt 253001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 E:\FR\FM\18FEN1.SGM 18FEN1 jbell on DSKJLSW7X2PROD with NOTICES