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27064 Federal Register / Vol. 50, No. 126 / Monday, July 1, 1985 / Notices 27064 FdrlRgse o.5,N.16/MnaJl ,18 oie the apparent conditions of its use. Upon will enter summary judgment Convention on Psychotropic Substances. finalization of the withdrawal of against the person(s) who request(s) the Article 2 of the Convention on approvals of the applications identified hearing, making findings and Psychotropic Substances provides that if above, the corresponding regulation conclusions, and denying a hearing. WHO has information about a All shall be revoked as provided in section submissions under this notice substance which in its opinion may 512(i) of the act (21 U.S.C. 360b(i)) (21 shall be filed in four copies. All require international control or change CFR 555.110c). submissions under this notice, except for in such control, it shall so notify the In accordance with provisions of data and information prohibited from Secretary-General of the United Nations section 512 of the act (21 U.S.C. 360b) public disclosure under section 301(j) of and provide the Secretary-General with and regulations promulgated under it (21 the act (21 U.S.C. 331(j)) or 18 U.S.C. information in support of its opinion. CFR Part 514) and under authority 1905, may be seen in the Dockets The Controlled Substances Act (CSA) delegated to him by 21 CFR 5.84, the Management Branch (address above) (21 U.S.C. 801 et seq.) provides that Director hereby provides an opportunity between 9 a.m. and 4 p.m., Monday when WHO notifies the United States for hearing to show why approval of the through Friday. under Article 2 of the Convention on new animal applications listed This notice is issued under the Federal Psychotropic Substances that WHO has above, and all supplements thereto, Food, Drug, and Cosmetic Act (sec. 512, information that may justify adding a should not be withdrawn. Any hearing 82 Stat. 343-351 (21 U.S.C. 360b)) and drug or other substance to one of the would be subject to the provisions of 21 under authority delegated to the schedules of the Convention, CFR Part 12. Director of the Center for Veterinary transferring a drug or substance from Copies of the documents cited in this Medicine (21 CFR 5.84). one schedule to another, or deleting it have been placed on file with the of notice Dated: June 25,1985. from the schedules, the Secretary Dockets Management Branch and are must transmit the notice to the Lester M. Crawford, State available for examination. Because - Secretary of Health and Human certain documents concern ongoing FDA Director,Center for VeterinaryMedicine. Services. The Secretary must then investigations, examination, copying, [FR Doc. 85-15669 Filed 6-28-85; 8:45 am] publish the notice in the Federal and distribution of those documents will BILUN CODE 4160-01- Register and provide opportunity for be restricted in accordance with interested persons to submit comments applicable regulations. [Docket No. 85N-0286] to assist the Department of Health and If an applicant decides to seek a Human Services (DHHS) in preparing hearing, the applicant shall file (1) on or International Drug Scheduling; scientific and medical evaluations about before (July 31, 1985) a written notice of Convention on Psychotropic the drug or substance. appearance and request for a-hearing, Substances; -Type The agency has been provided with and (2) on or before (August 30,1985) and/or Drug Substances an advance copy of the WHO the data, information, and analyses notification -and has included it in this as AGENCY: Food and Drug Administration. relied on to justify a hearing, Federal Register notice. The specified in 21 CFR 514.200. ACTION: Notice. authenticated copy of the WHO may also Any other interested person notification will be placed on display in submit comments on this notice. SUMMARY: The Food and Drug the Dockets Management Branch when Procedures and requirements governing Administration (FDA) is requesting it is received. The notice requests the this notice of opportunity for hearing, a interested persons to submit data or United States to submit data concerning notice of appearance and request for comments concerning abuse potential, hearing, submission of data, actual abuse, and medical usefulness the abuse potential, actual abuse, and medical usefulness of 31 barbiturate- information, and analyses to justify a and trafficking of 31 barbiturate-type type sedative and/or hypnotic drug hearing, other comments, and a grant or sedative and/or hypnotic drug denial of hearing, are contained in 21 substances. This information will be substances. The contents of the notice CFR 514.200. considered in preparing a response from follows: The failure of the applicant to file the United States to the World Health United Nations timely written appearance and request Organization (WHO) regarding abuse Vienna International Centre and trafficking of for hearing as required by 21 CFR liability, actual abuse, The Secretary-General of the United 514.200 constitutes an election by the these drugs. WHO will use this Nations has the honour to draw attention to a applicant not to make use of the information to consider whether to request from the Director-General of the opportunity for a hearing. The Director recommend that certain international World Health Organization for assistance in will summarily enter a final order restrictions be placed on these drugs. obtaining data on the following thirty-one withdrawing approval of the This notice requesting information is substances: application. required by law. 1. A request for a hearing may not rest DATE: Comments by July 30, 1985. 2. : 5-allyl-5-phenylbarbituric acid upon mere allegations or denials, but 3. ADDRESS: Written comments to the must set forth specific facts showing 4. (also known as Dockets Management Branch (HFA- that there is a genuine and substantial benzobarbitone) 305), Food and Drug Administration, Rm. issue of fact that requires a hearing. If it 5. 4-62, 5600 Fishers Lane, Rockville, MD conclusively appears from the face of 6. : 5-(2-bromoallyl)-5-(1- 20857. methylpropyl)-barbituric acid the data, information, and factual 7. Sodium analyses in the request for hearing that FOR FURTHER INFORMATION CONTACT: I. David Wolfson, Office of Health 8. : 5-butyl-5-ethylbarbituric acid there is no genuine and substantial issue 9. : 5-(-1-cyclopenten-2-yl)- of fact that precludes the withdrawal of Affairs (HFY-20), Food and Drug 5-allylbarbituric acid approval of the application(s), or that Administration, 5600 Fishers Lane, 10. the request for hearing is not made in Rockville, MD 20857, 301-443-1382. 11. the required format or with the required SUPPLEMENTARY INFORMATION: The 12. Heptabarbital (also known as ) analyses, the Commissioner of Food and United States is a party to the 1971 13. : 5-hexyl-5-ethylbarbituric acid Federal Register / Vol. 50, No. 126 / Monday, July 1, 1985 / Notices 27065 ..... I

14. 5. Number of seizures of the substance in Interested persons may, on or before 15. Mephebarbital (also known as the illicit traffic during the previous three July 30, 1985, submit to the Dockets ) years and the quantities involved. Management Branch (address above) 16. 6. Identification of the substance as of local written comments regarding this action. 17. or foreign manufacture and indication of any This short comment period is necessary 18. commercial markings. in a timely 19. 7. Existence of clandestine laboratories to assure that DHHS may, 20. manufacturing the substance. fashion, provide the requested 21. sodium Therefore, as required by section comments and data. Two copies of any 22. : 5-(2-bromoallyl)-5- 201(d)(2](A) of the CSA (21 U.S.C. comments are to be submitted, except isopropylbarbituric acid 811(d)(2)(A)}, FDA on behalf of DHHS that individuals may submit one copy. 23. Proxibarbal Comments should provide data and/or 24. Secbutabarbital (also known as invites interested persons to submit data or comments regarding the named 31 information in the format described in secbutobarbital) the WHO questionnaire for data 25. drugs. 26. Of the 31 drug substances listed in the collection found above. Comments are 27. sodium: Sodium 5-allyl-5-(1- WHO notice, only 19 have a marketing to be identified with the docket number methylbutyl)-2-thiobarbiturate history in the United States. The found in brackets in the heading of this 28. : 5-(1-methylpropyl)-5- available data indicate that 16 of the document. Received comments may be ethyl-2-thiobarbituric acid drug substances are currently available seen in the office above between 9 a.m. 29. Thiopental Sodium in the United States. All 16 substances and 4 p.m., Monday through Friday. 30. are controlled under the CSA. They 31. Dated: June 25, 1985. The WHO twenty-third Expert Committee include: Mervin H. Shumate, ' on Drug Dependence, to be convened from 21 Allobarbital Methohexital Acting Associate Commissionerfor Alphenal Probarbital to 26 April 1986, will examine the thirty-one Aprobarbital Sodium Thiobutabarbital Regulatory Affairs. substances listed above to determine if any Butalbital Talbutal [FR Doc. 85-15671 Filed 6-28-85; 8:45am] proposals should be made concerning their Butobarbital Thialbarbital BILLING CODE 416-1t-M possible control under the provisions of the Cyclopentobarbital Thiamylal Sodium Convention on Psychotropic Substances. In Hexobarbital Thiopental Sodium this connection, it would be appreciated if the Metharbital Vinbarbital Office of Human Development Government would submit data on any of the are thirty-one substances. It would greatly assist Of these drug substances, all Services the Secretary-General if such data were controlled in Schedule III of the CSA submitted on a substance-by-substance basis except for methohexital which is found Program Announcement No. HDS-85.2; following the outline contained in the in Schedule IV. Administration for Children, Youth and questionnaire attached to the present note as Data and information received in Families Child Abuse and Neglect an annex. response to this notice will be used to Research, Demonstration and Service In view of the fact that a report must be prepare supplemental scientific and Improvement Projects prepared for WHO on this subject, it would medical information on these drugs in be appreciated if the information could be addition to that previously provided by AGENCY: Office of Human Development transmitted to the Secretary-General by 30 of Services (HDS), HHS. August 1985. Replies should be addressed to the United States to WHO. (A copy the attention of the Director of the Division of that information is on file in the Dockets ACTION: Amendment of announcement Narcotic Drugs, Vienna International Centre, Management Branch under this docket.) of availability of funds and request for P.O. Box 500, A-1400 Vienna, Austria. DHHS will forward that information to applications under the HDS May 15, 1985. WHO, through the Secretary of State, Discretionary Grants Program. UNITED NATIONS DIVISION OF for WHO's consideration in deciding NARCOTIC DRUGS, Vienna International whether to recommend international SUMMARY: This document amends Centre, A-1400 Vienna, Austria. control of any of these drugs. Such Program Announcement No. HDS-85.2 Questionnaire for data collection for use by control could limit, among other things, published in the Federal Register on the World Health Organization and the the manufacture and distribution Friday, June 21, 1985 (50 FR 25860) to Commission on Narcotic Drugs of the (import/export] of these drugs and could extend the due date for receipt of Economic and Social Council Substance reported on impose certain recordkeeping applications to August 12, 1985. 1. Availability of the substance (registered, requirements on them. FOR FURTHER INFORMATION CONTACT. marketed, dispensed, etc.). Upon receipt of the information, Roland Sneed (202] 245-2840. 2. National control measures applied to the DHHS will not make any substance as compared to measures applied recommendations to WHO regarding SUPPLEMENTARTY INFORMATION: On June to narcotic drugs or psychotropic substances whether any of these drugs should be 21, 1985, the Administapion for Children, (e.g. prescription requirements, licensing of subjected to international controls. Youth and Families (ACYF] published manufacture and distribution, control of Rather, DHHS will defer such an announcement of the availability of import and export, etc.). considerati6n until WHO has made approximately $2 million for new grants 3. Extent of abuse of the substance. relating to the prevention, identification, 4. Degree of seriousness of the public official recommendations to the Commission on Narcotic Drugs, which treatment and remediation of child health and social problems ' associated with abuse and neglect, including child abuse of the substance. are expected to be made in 1986. Any DHHS position regarding international sexual abuse. The closing date for control of these drugs will be preceded receipt of applications under that I Examples of public health and social problems announcement was July 22, 1985. are acute intoxication, accidents, work absenteeism, by another Federal Register notice mortality, behavior problems, criminality, etc. For a soliciting public comment as required by ACYF has determined that, in view of thorough examination of the question please refer to 21 U.S.C. 811(d](2)(B]. the complex nature of the subject areas the WHO publication entitled "Assessment of to be addressed, an extension of the due Public Health and Social Problems Associated with the Use of Psychotropic Drugs" (No. 656 in the WHO publication entitled "Guidelines for the date for receipt of applications is WHO Technical Report Series) and Chapter 7 of the Control of Narcotic and Psychotropic Substances." warranted in order to afford potential +(,121/,1(

Citation: 50 Fed. Reg. 27064 (1985), Monday, July 1, 1985, pages 26961 - 27212

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