Notices - 1998
[Federal Register Volume 63, Number 205 (Friday, October 23, 1998)] [Notices] [Pages 56941-56942] From the Federal Register Online via the Government Printing Office [www.gpo.gov] [FR Doc No: 98-28417]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[DEA Number 178N]
Industrial Uses and Handling of Gamma-butyrolactone; Solicitation of Information
AGENCY: Drug Enforcement Administration.
ACTION: Notice of request for information.
SUMMARY: The Drug Enforcement Administration (DEA) is soliciting information on the chemical gamma-butyrolactone (GBL). GBL has been identified as the major precursor to gamma-hydroxybutyrate (GHB), a drug substance that is under consideration for control in the Controlled Substances Act (21 U.S.C. 801 et seq.). DEA is seeking information on the GBL trade so that diversion of GBL may be prevented with minimal impact on legitimate trade, in the event that GHB becomes a controlled substance. The DEA is soliciting information on the manufacturing, distribution, consumption, storage, disposal and uses of GBL.
ADDRESSES: Responses to this notice may be sent to Frank Sapienza, Chief, Drug and Chemical Evaluation Section, Office of Diversion Control, Drug Enforcement Administration, Washington, D.C. 20537.
DATE: Responses to this notice may be submitted by December 22, 1998.
SUPPLEMENTARY INFORMATION: The chemical gamma-butyrolactone (GBL) has been identified as the principal precursor used in the clandestine manufacture of gamma-hydroxybutyrate (GHB). GBL is also identified as dihydro-2(3H)-furanone; 1,2-butanolide; 1,4-butanolide; gamma- hydroxybutyric acid lactone; 3-hydroxybutyric acid lactone and 4- hydroxybutanoic acid lactone with Chemical Abstract Service number [96- 48-0]. GHB has been banned from sale for human consumption by the Food and Drug Administration, controlled in several states and is under consideration for placement into the Controlled Substance Act (CSA). Control of GHB under the CSA would permit the administrative control of GBL as either an immediate precursor (21 U.S.C. 811(e)) or listed chemical (21 U.S.C. 802(34)) if certain findings are made. The DEA is studying the manufacturing, industrial uses and distributions of GBL to become aware of possible methods of diversion from these legitimate sources. This information will help the DEA to evaluate the potential impact on legitimate industry if control of GBL is necessary under the CSA. Control measures, if warranted and imposed, would regulate the manufacture, distribution and other handling of GBL.
DEA is aware this substance is used by industry as a synthetic intermediate with application to polymers, pharmaceuticals and agricultural industries, as a solvent, cleaning agent, and cosmetic ingredient. DEA recognizes that regulation of GBL may have some effect upon these, and other, industrial activities. However, DEA is not aware of the entire scope of use of GBL by industry and consumers. Therefore, DEA invites all interested
persons to provide DEA with any information on the manner of manufacturing, distribution, consumption, storage, disposal and uses of GBL by industry and others. Both quantitative and qualitative data is sought.
Such information may be submitted to the Drug and Chemical Evaluation Section and is requested by December 22, 1998. Information designated as confidential or proprietary will be treated accordingly. The release of confidential business information that is protected from disclosure under Exemption 4 of the Freedom of Information Act, 5 U.S.C. 552(b)(4) (FOIA), is governed by section 310(c) of the CSA (21 U.S.C. 830(c)) and the Department of Justice procedures set forth in 28 CFR 16.7.
Dated: October 16, 1998.
John H. King,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 98-28417 Filed 10-22-98; 8:45 am]
BILLING CODE 4410-09-M
NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).