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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Docket ID: [Docket No. FDA-2008-N-0448]

NOTICE: NOTICES

ACTION: International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs:

DOCUMENT ACTION: Notice.

SUBJECT CATEGORY: International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Gamma-hydroxybutyric acid; Ketamine; Dextromethorphan; N-benzylpiperazine; 1-(3- trifluoromethylphenyl)piperazine; 1-(3-chlorophenyl)piperazine; 1-(4- Methoxyphenyl)piperazine; 1-(3,4-methylenedioxybenzyl)piperazine; Gamma-butyrolactone; 1,4-Butanediol

DATES: Submit written or electronic comments by October 6, 2008.

DOCUMENT SUMMARY: The Food and Drug Administration (FDA) is requesting comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 10 drug substances. These comments will be considered in preparing the United States' response to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs. WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drugs. This notice requesting comments is required by the Controlled Substances Act (CSA).

SUMMARY: Gamma-hydroxybutyric acid; Ketamine; Dextromethorphan; N-benzylpiperazine; 1-(3-trifluoromethylphenyl)piperazine; etc.,

SUPPLEMENTAL INFORMATION

The United States is a party to the 1971 Convention on Psychotropic Substances (the Psychotropic Convention). Article 2 of the Psychotropic Convention provides that if a party to the convention or WHO has information about a substance, which in its opinion may require international control or change in such control, it should notify the Secretary General of the United Nations (the SecretaryGeneral) and provide the SecretaryGeneral with information in support of its opinion.

The CSA (21 U.S.C. 811 et seq.) (Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970) provides that when WHO notifies the United States under Article 2 of the Psychotropic Convention that it has information that may justify: (1) Adding a drug or other substances to one of the schedules of the convention, (2) transferring a drug or substance from one schedule to another, or (3) deleting it from the schedules, the Secretary of State must transmit the notice to the Secretary of Health and Human Services (the Secretary of HHS). The Secretary of HHS must then publish the notice in the Federal Register and provide opportunity for interested persons to submit comments that HHS will consider in its preparation of the scientific and medical evaluations of the drug or substance. I. WHO Notification

The Secretary of HHS received the following notices from WHO:

Ref.: C.L.16.2008
WHO Questionnaire for Collection of Information for Review of DependenceProducing Psychoactive Substances

The World Health Organization presents its compliments and has the pleasure of informing Member States and Associate Members that the Thirtyfifth Expert Committee on Drug Dependence will meet from 20 to 23 April 2009 to review the following substances:

1. Gammahydroxybutyric acid (GHB)

2. Ketamine INN

3. Dextromethorphan pINN

4. Nbenzylpiperazine (BZP)

5. 1(3trifluoromethylphenyl)piperazine (TFMPP)

6. 1(3chlorophenyl)piperazine (mCPP)

7. 1(4Methoxyphenyl)piperazine (MeOPP)

8. 1(3,4methylenedioxybenzyl)piperazine (MDBP)

9. Gammabutyrolactone

10. 1,4Butanediol

One of the essential elements of the established review procedure is for the Secretariat to collect relevant information from Member States to prepare a Critical Review Report for submission to the Expert Committee on Drug Dependence. The World Health Organization invites Member States to collaborate, as in the past, in this process by providing pertinent information mentioned in the attached questionnaire concerning substances listed above.

Further clarification on any of the above items can be obtained from Quality Assurance and Safety: Medicines, Department of Medicines Policy and Standards, WHO, Geneva, to which replies should be sent not later than 20 September 2008.

The World Health Organization takes this opportunity to renew to Member States and Associate Members the assurance of its highest consideration.

GENEVA, 28 May 2008

* * * * *

If statistical information requested is not readily available, a brief descriptive answer would be appreciated.

Please attach copies of relevant study reports and other background information as appropriate.
* * * * *
1. GAMMAHYDROXYBUTYRIC ACID (GHB)

1. LEGITIMATE USE OF THE SUBSTANCE

1.1 Is the substance currently authorized as a medical or veterinary product? (Yes/No)

1.2 If ``yes,'' since when has it been on the market?

1.3 Please indicate registered indications alphabetically.

1.4 Please indicate known offlabel medical indications for which the substance is also used in your country.

1.5 Please indicate dosage form(s) and strength(s); also indicate special properties like slow release, etc.
Dosage Form Strength Remark .................................. .................................. .................................. .................................. .................................. .................................. .................................. .................................. [[Page 51824]]

1.6 Please indicate brand names alphabetically (no dosage forms, strengths, etc.).

1.7 Are there any technical uses for the substance in your country?

If ``yes,'' please specify (Yes/No).

1.8 Is there any other legitimate use of the substance?

If ``yes,'' please specify (Yes/No).

1.9 If there is a legitimate use of the substance, how is the substance supplied? (Manufactured in the country/Imported/Both) 2. ABUSE OF THE SUBSTANCE

2.1 Is the substance used in a harmful way in your country? \1\ (Yes/No/Unknown)
\1\ Harmful use is defined as a pattern of psychoactive drug use that causes damage to health, either mental or physical. Harmful use of drugs by an individual often has adverse effects on the drug user's family, the community, and society in general.

2.2 If ``yes,'' any information on how this is used (including route of administration)?

2.3 If ``yes,'' any information on the extent of harmful use?

2.4 If ``yes,'' any information on the extent of public health or social problems associated with the harmful use of the substance (statistics on overdose deaths, dependence, etc.)?

3. CONTROL OF THE SUBSTANCE

3.1 Is the substance controlled under legislation that is intended to regulate availability of substances of abuse (Controlled Substances Act or similar)? (Yes/No)

3.2 If yes, are there illicit activities involving the substance:

a. clandestine manufacture (Yes/No)

b. smuggling (Yes/No)

c. diversion (Yes/No)

d. other (please specify) (Yes/No)

3.3 Total quantity of seizures (kg/liter/number of ampoules).

3.4 Any additional information with regard to questions 3.2 and 3.3.
4. IMPACT OF SCHEDULING
(Gammahydroxybutyrate is in Schedule IV of the Convention on Psychotropic Substances of 1971 currently.)

4.1 If gammahydroxybutyric acid (GHB) is placed under more strict international control, do you think that its availability for medical use will be affected? (Yes/No)

4.2 If ``yes,'' how do you think that a transfer will impact its medical availability?
2. KETAMINE INN

1.LEGITIMATE USE OF THE SUBSTANCE

1.1 Is the substance currently authorized as a medical or veterinary product? (Yes/No)

1.2 If ``yes,'' since when has it been on the market?

1.3 Please indicate registered indications alphabetically.

1.4 Please indicate known offlabel medical indications for which the substance is also used in your country.

1.5 Please indicate dosage form(s) and strength(s); also indicate special properties like slow release, etc.
Dosage Form Strength Remark .................................. .................................. .................................. .................................. .................................. .................................. .................................. ..................................

1.6 Please indicate brand names alphabetically (no dosage forms, strengths, etc.).

1.7 Are there any technical uses for the substance in your country?

If ``yes,'' please specify (Yes/No).

1.8 Is there any other legitimate use of the substance? If ``yes,'' please specify (Yes/No).

1.9 If there is a legitimate use of the substance, how is the substance supplied? (Manufactured in the country/Imported/Both) 2. ABUSE OF THE SUBSTANCE

2.1 Is the substance used in a harmful way in your country? (Yes/No/Unknown)

2.2 If ``yes,'' any information on how this is used (including route of administration)?

2.3 If ``yes,'' any information on the extent of harmful use?

2.4 If ``yes,'' any information on the extent of public health or social problems associated with the harmful use of the substance (statistics on overdose deaths, dependence, etc.)?

3. CONTROL OF THE SUBSTANCE

3.1 Is the substance controlled under legislation that is intended to regulate availability of substances of abuse (Controlled Substances Act or similar)? (Yes/No)

3.2 If ``yes,'' are there illicit activities involving the substance:

a. clandestine manufacture (Yes/No)

b. smuggling (Yes/No)

c. diversion (Yes/No)

d. other (please specify) (Yes/No)

3.3 Total quantity of seizures (kg/number of tablets/number of ampoules).

3.4 Any additional information with regard to questions 3.2 and 3.3.
4. IMPACT OF SCHEDULING
(Ketamine is not scheduled in one of the drug conventions currently.)

4.1 If ketamine is placed under international control, do you think that its availability for medical use will be affected? (Yes/ No)

4.2 If ``yes,'' how do you think that scheduling will impact its medical availability?
3. DEXTROMETHORPHAN pINN

1. LEGITIMATE USE OF THE SUBSTANCE

1.1 Is the substance currently authorized as a medical or veterinary product? (Yes/No)

1.2 If ``yes,'' since when has it been on the market?

1.3 Please indicate registered indications alphabetically.

1.4 Please indicate known offlabel medical indications for which the substance is also used in your country.

1.5 Please indicate dosage form(s) and strength(s); also indicate special properties like slow release, etc.
Dosage Form Strength Remark .................................. .................................. .................................. .................................. .................................. .................................. .................................. ..................................

1.6 Please indicate brand names alphabetically (no dosage forms, strengths, etc.).

1.7 Are there any technical uses for the substance in your country? If ``yes,'' please specify (Yes/No).

1.8 Is there any other legitimate use of the substance? If ``yes,'' please specify (Yes/No).

[[Page 51825]]

1.9 If there is a legitimate use of the substance, how is the substance supplied? (Manufactured in the country/Imported/Both) 2. ABUSE OF THE SUBSTANCE

2.1 Is the substance used in a harmful way in your country? (Yes/No /Unknown)

2.2 If ``yes,'' any information on how this is used (including route of administration)?

2.3 If ``yes,'' any information on the extent of harmful use?

2.4 If ``yes,'' any information on the extent of public health or social problems associated with the harmful use of the substance (statistics on overdose deaths, dependence, etc.)?

3. CONTROL OF THE SUBSTANCE

3.1 Is the substance controlled under legislation that is intended to regulate availability of substances of abuse (Controlled Substances Act or similar)? (Yes/No)

3.2 If ``yes,'' are there illicit activities involving the substance:

a. clandestine manufacture (Yes/No)

b. smuggling (Yes/No)

c. diversion (Yes/No)

d. other (please specify) (Yes/No)

3.3 Total quantity of seizures (kg/number of tablets/number of ampoules).

3.4 Any additional information with regard to questions 3.2 and 3.3.
4. IMPACT OF SCHEDULING
(Dextromethorphan is not scheduled in one of the drug

conventions currently.)

4.1 If dextromethorphan is placed under international control, do you think that its availability for medical use will be affected? (Yes/No)

4.2 If ``yes,'' how do you think that scheduling will impact its medical availability?
4. NBENZYLPIPERAZINE (BZP)

1. LEGITIMATE USE OF THE SUBSTANCE

1.1 Is the substance currently authorized as a medical or veterinary product? (Yes/No)

1.2 If ``yes,'' since when has it been on the market?

1.3 Please indicate registered indications alphabetically.

1.4 Please indicate known offlabel medical indications for which the substance is also used in your country.

1.5 Please indicate dosage form(s) and strength(s); also indicate special properties like slow release, etc.
Dosage Form Strength Remark .................................. .................................. .................................. .................................. .................................. .................................. .................................. ..................................

1.6 Please indicate brand names alphabetically (no dosage forms, strengths, etc.).

1.7 Are there any technical uses for the substance in your country?

If ``yes,'' please specify(Yes/No).

1.8 Is there any other legitimate use of the substance? If ``yes,'' please specify (Yes/No).

1.9 If there is a legitimate use of the substance, how is the substance supplied? (Manufactured in the country/Imported/Both) 2. ABUSE OF THE SUBSTANCE

2.1 Is the substance used in a harmful way in your country? (Yes/No/Unknown)

2.2 If ``yes,'' any information on how this is used (including route of administration)?

2.3 If ``yes,'' any information on the extent of harmful use?

2.4 If ``yes,'' any information on the extent of public health or social problems associated with the harmful use of the substance (statistics on overdose deaths, dependence, etc.)?

3. CONTROL OF THE SUBSTANCE

3.1 Is the substance controlled under legislation that is intended to regulate availability of substances of abuse (Controlled Substances Act or similar)? (Yes/No)

3.2 If ``yes,'' are there illicit activities involving the substance:

a. clandestine manufacture (Yes/No)

b. smuggling (Yes/No)

c. diversion (Yes/No)

d. other (please specify) (Yes/No)

3.3 Total quantity of seizures (kg/number of tablets/number of ampoules).

3.4 Any additional information with regard to questions 3.2 and 3.3.
5. 1(3TRIFLUOROMETHYL PHENYL)PIPERAZINE (TFMPP)

1. LEGITIMATE USE OF THE SUBSTANCE

1.1 Is the substance currently authorized as a medical or veterinary product? (Yes/No)

1.2 If ``yes,'' since when has it been on the market?

1.3 Please indicate registered indications alphabetically.

1.4 Please indicate known offlabel medical indications for which the substance is also used in your country.

1.5 Please indicate dosage form(s) and strength(s); also indicate special properties like slow release, etc.
Dosage Form Strength Remark .................................. .................................. .................................. .................................. .................................. .................................. .................................. ..................................

1.6 Please indicate brand names alphabetically (no dosage forms, strengths, etc.).

1.7 Are there any technical uses for the substance in your country? If ``yes,'' please specify(Yes/No).

1.8 Is there any other legitimate use of the substance? If ``yes,'' please specify (Yes/No).

1.9 If there is a legitimate use of the substance, how is the substance supplied? (Manufactured in the country/Imported/Both) 2. ABUSE OF THE SUBSTANCE

2.1 Is the substance used in a harmful way in your country? (Yes/No/Unknown)

2.2 If ``yes,'' any information on how this is used (including route of administration)?

2.3 If ``yes,'' any information on the extent of harmful use?

2.4 If ``yes,'' any information on the extent of public health or social problems associated with the harmful use of the substance (statistics on overdose deaths, dependence, etc.)?

3. CONTROL OF THE SUBSTANCE

3.1 Is the substance controlled under legislation that is intended to regulate availability of substances of abuse (Controlled Substances Act or similar)? (Yes/No)

3.2 If yes, are there illicit activities involving the substance:

a. clandestine manufacture (Yes/No)

b. smuggling (Yes/No)

c. diversion (Yes/No)

d. other (please specify) (Yes/No)

3.3 Total quantity of seizures (kg/number of tablets/number of ampoules)

[[Page 51826]]

3.4 Any additional information with regard to questions 3.2 and 3.3.
6. 1(3CHLOROPHENYL)PIPERAZINE (MCCP)

1. LEGITIMATE USE OF THE SUBSTANCE

1.1 Is the substance currently authorized as a medical or veterinary product? (Yes/No)

1.2 If ``yes,'' since when has it been on the market?

1.3 Please indicate registered indications alphabetically.

1.4 Please indicate known offlabel medical indications for which the substance is also used in your country.

1.5 Please indicate dosage form(s) and strength(s); also indicate special properties like slow release, etc.
Dosage Form Strength Remark .................................. .................................. .................................. .................................. .................................. .................................. .................................. ..................................

1.6 Please indicate brand names alphabetically (no dosage forms, strengths, etc.).

1.7 Are there any technical uses for the substance in your country?

If ``yes,'' please specify (Yes/No).

1.8 Is there any other legitimate use of the substance? If ``yes,'' please specify(Yes/No).

1.9 If there is a legitimate use of the substance, how is the substance supplied? (Manufactured in the country/Imported/Both) 2. ABUSE OF THE SUBSTANCE

2.1 Is the substance used in a harmful way in your country? (Yes/No/Unknown)

2.2 If ``yes,'' any information on how this is used (including route of administration)?

2.3 If ``yes,'' any information on the extent of harmful use?

2.4 If ``yes,'' any information on the extent of public health or social problems associated with the harmful use of the substance (statistics on overdose deaths, dependence, etc.)?

3. CONTROL OF THE SUBSTANCE

3.1 Is the substance controlled under legislation that is intended to regulate availability of substances of abuse (Controlled Substances Act or similar)? (Yes/No)

3.2 If yes, are there illicit activities involving the substance:

a. clandestine manufacture (Yes/No)

b. smuggling (Yes/No)

c. diversion (Yes/No)

d. other (please specify) (Yes/No)

3.3 Total quantity of seizures (kg/number of tablets/number of ampoules).

3.4 Any additional information with regard to questions 3.2 and 3.3.
7. 1(4METHOXYPHENYL)PIPERAZINE (MeOPP)

1. LEGITIMATE USE OF THE SUBSTANCE

1.1 Is the substance currently authorized as a medical or veterinary product? (Yes/No)

1.2 If ``yes,'' since when has it been on the market?

1.3 Please indicate registered indications alphabetically.

1.4 Please indicate known offlabel medical indications for which the substance is also used in your country.

1.5 Please indicate dosage form(s) and strength(s); also indicate special properties like slow release, etc.
Dosage Form Strength Remark .................................. .................................. .................................. .................................. .................................. .................................. .................................. ..................................

1.6 Please indicate brand names alphabetically (no dosage forms, strengths, etc.).

1.7 Are there any technical uses for the substance in your country? If ``yes,'' please specify (Yes/No).

1.8 Is there any other legitimate use of the substance? If ``yes,'' please specify (Yes/No).

1.9 If there is a legitimate use of the substance, how is the substance supplied? (Manufactured in the country/Imported/Both) 2. ABUSE OF THE SUBSTANCE

2.1 Is the substance used in a harmful way in your country? (Yes/No/Unknown)

2.2 If ``yes,'' any information on how this is used (including route of administration)?

2.3 If ``yes,'' any information on the extent of harmful use?

2.4 If ``yes,'' any information on the extent of public health or social problems associated with the harmful use of the substance (statistics on overdose deaths, dependence, etc.)?

3. CONTROL OF THE SUBSTANCE

3.1 Is the substance controlled under legislation that is intended to regulate availability of substances of abuse (Controlled Substances Act or similar)? (Yes/No)

3.2 If ``yes,'' are there illicit activities involving the substance:

a. clandestine manufacture (Yes/No)

b. smuggling (Yes/No)

c. diversion (Yes/No)

d. other (please specify) (Yes/No)

3.3 Total quantity of seizures (kg/number of tablets/number of ampoules).

3.4 Any additional information with regard to questions 3.2 and 3.3.
8. 1(3,4METHYLENEDIOXYBENZYL)PIPERAZINE (MDBP)

1. LEGITIMATE USE OF THE SUBSTANCE

1.1 Is the substance currently authorized as a medical or veterinary product? (Yes/No)

1.2 If ``yes,'' since when has it been on the market?

1.3 Please indicate registered indications alphabetically.

1.4 Please indicate known offlabel medical indications for which the substance is also used in your country.

1.5 Please indicate dosage form(s) and strength(s); also indicate special properties like slow release, etc.
Dosage Form Strength Remark .................................. .................................. .................................. .................................. [[Page 51827]]
.................................. .................................. .................................. ..................................

1.6 Please indicate brand names alphabetically (no dosage forms, strengths, etc.).

1.7 Are there any technical uses for the substance in your country? If ``yes,'' please specify (Yes/No).

1.8 Is there any other legitimate use of the substance? If ``yes,'' please specify (Yes/No).

1.9 If there is a legitimate use of the substance, how is the substance supplied? (Manufactured in the country/Imported/Both) 2. ABUSE OF THE SUBSTANCE

2.1 Is the substance used in a harmful way in your country? (Yes/No/Unknown)

2.2 If ``yes,'' any information on how this is used (including route of administration)?

2.3 If ``yes,'' any information on the extent of harmful use?

2.4 If ``yes,'' any information on the extent of public health or social problems associated with the harmful use of the substance (statistics on overdose deaths, dependence, etc.)?

3. CONTROL OF THE SUBSTANCE

3.1 Is the substance controlled under legislation that is intended to regulate availability of substances of abuse (Controlled Substances Act or similar)? (Yes/No)

3.2 If yes, are there illicit activities involving the substance:

a. clandestine manufacture (Yes/No)

b. smuggling (Yes/No)

c. diversion (Yes/No)

d. other (please specify) (Yes/No)

3.3 Total quantity of seizures (kg/number of tablets/number of ampoules).

3.4 Any additional information with regard to questions 3.2 and 3.3.
9. GAMMABUTYROLACTONE

1. LEGITIMATE USE OF THE SUBSTANCE

1.1 Is the substance currently authorized as a medical or veterinary product? (Yes/No)

1.2 If ``yes,'' since when has it been on the market?

1.3 Please indicate registered indications alphabetically.

1.4 Please indicate known offlabel medical indications for which the substance is also used in your country.

1.5 Please indicate dosage form(s) and strength(s); also indicate special properties like slow release, etc.
Dosage Form Strength Remark .................................. .................................. .................................. .................................. .................................. .................................. .................................. ..................................

1.6 Please indicate brand names alphabetically (no dosage forms, strengths, etc.).

1.7 Are there any technical uses for the substance in your country? If ``yes,'' please specify. (Yes/No)

1.8 Is there any other legitimate use of the substance? If ``yes,'' please specify (Yes/No).

1.9 If there is a legitimate use of the substance, how is the substance supplied? Manufactured in the country/Imported/Both) 2. ABUSE OF THE SUBSTANCE

2.1 Is the substance used in a harmful way in your country? (Yes/No/Unknown)

2.2 If ``yes,'' any information on how this is used (including route of administration)?

2.3 If ``yes,'' any information on the extent of harmful use?

2.4 If ``yes,'' any information on the extent of public health or social problems associated with the harmful use of the substance (statistics on overdose deaths, dependence, etc.)?

3. CONTROL OF THE SUBSTANCE

3.1 Is the substance controlled under legislation that is intended to regulate availability of substances of abuse (Controlled Substances Act or similar)? (Yes/No)

3.2 If yes, are there illicit activities involving the substance:

a. clandestine manufacture (Yes/No)

b. smuggling (Yes/No)

c. diversion (Yes/No)

d. other (please specify) (Yes/No)

3.3 Total quantity of seizures (kg/liter).

3.4 Any additional information with regard to questions 3.2 and 3.3.
10. 1,4BUTANEDIOL

1. LEGITIMATE USE OF THE SUBSTANCE

1.1 Is the substance currently authorized as a medical or veterinary product? (Yes/No)

1.2 If ``yes,'' since when has it been on the market?

1.3 Please indicate registered indications alphabetically.

1.4 Please indicate known offlabel medical indications for which the substance is also used in your country.

1.5 Please indicate dosage form(s) and strength(s); also indicate special properties like slow release, etc.
Dosage Form Strength Remark .................................. .................................. .................................. .................................. .................................. .................................. .................................. ..................................

1.6 Please indicate brand names alphabetically (no dosage forms, strengths, etc.).

1.7 Are there any technical uses for the substance in your country? If ``yes,'' please specify (Yes/No).

1.8 Is there any other legitimate use of the substance? If ``yes,'' please specify (Yes/No).

1.9 If there is a legitimate use of the substance, how is the substance supplied? (Manufactured in the country/Imported/Both) 2. ABUSE OF THE SUBSTANCE

2.1 Is the substance used in a harmful way in your country? (Yes/No/Unknown)

2.2 If ``yes,'' any information on how this is used (including route of administration)?

2.3 If ``yes,'' any information on the extent of harmful use? [[Page 51828]]

2.4 If ``yes,'' any information on the extent of public health or social problems associated with the harmful use of the substance (statistics on overdose deaths, dependence, etc.)?

3. CONTROL OF THE SUBSTANCE

3.1 Is the substance controlled under legislation that is intended to regulate availability of substances of abuse (Controlled Substances Act or similar)? (Yes/No)

3.2 If yes, are there illicit activities involving the substance:

a. clandestine manufacture (Yes/No)

b. smuggling (Yes/No)

c. diversion (Yes/No)

d. other (please specify) (Yes/No)

3.3 Total quantity of seizures (kg/liter).

3.4 Any additional information with regard to questions 3.2 and 3.3.

II. Background

Gammahydroxybutyric acid (GHB) is classified as a central nervous system depressant. In 2002, FDA approved a GHBcontaining product, Xyrem, for the treatment of cataplexy associated with narcolepsy. Xyrem was approved under the regulations in 21 CFR 314.520, and the product labeling contained a comprehensive risk management program, which includes restricted distribution of the drug through a central pharmacy. Xyrem is controlled domestically in Schedule III of the CSA, while bulk GHB and all other material containing GHB is controlled in Schedule I. In addition, illicit use of Xyrem is subject to Schedule I penalties of the CSA. GHB is controlled internationally in Schedule IV of the Psychotropic Convention. The WHO Expert Committee on Drug Dependence prereviewed GHB at its thirtyfourth meeting and recommended it for critical review at a future meeting.

Ketamine is classified as a rapidacting general anesthetic agent used for short diagnostic and surgical procedures that do not require skeletal muscle relaxation. It is marketed in the United States as an injectable. Ketamine is controlled domestically in Schedule III of the CSA. It is not controlled internationally under the Psychotropic Convention or the Single Convention on Narcotic Drugs. The WHO Expert Committee on Drug Dependence reviewed ketamine at its thirtyfourth meeting, and recommended that the Secretariat produce an updated version of the critical review for ketamine and present it to the next meeting of the WHO Expert Committee on Drug Dependence.

Dextromethorphan is classified as an oral antitussive agent for treating uncomplicated, nonproductive coughs. It is marketed in the United States without a prescription in mixtures such as syrups, lozenges, or in combination with antihistamines. Dextromethorphan is not controlled domestically or controlled internationally under the Psychotropic Convention or the Single Convention on Narcotic Drugs.

Nbenzylpiperazine (BZP) is used as an intermediate in chemical synthesis, but has been taken orally as either powder or tablets and by other routes including smoking or snorting. It has no medical use in the United States. BZP is controlled domestically in Schedule I of the CSA. BZP is not controlled internationally under the Psychotropic Convention or the Single Convention on Narcotic Drugs.

1(3trifluoromethylphenyl)piperazine (TFMPP) is a piperazinebased serotonin receptor agonist. It has no medical use in the United States. TFMPP is not controlled domestically or controlled internationally under the Psychotropic Convention or the Single Convention on Narcotic Drugs.

1(3chlorophenyl)piperazine (mCPP) is a piperazinebased serotonin receptor agonist. It has no medical use in the United States. mCPP is not controlled domestically or controlled internationally under the Psychotropic Convention or the Single Convention on Narcotic Drugs.

1(4Methoxyphenyl)piperazine (MeOPP) is a piperazinebased derivative. It has no medical use in the United States. MeOPP is not controlled domestically or controlled internationally under the Psychotropic Convention or the Single Convention on Narcotic Drugs.

1(3,4methylenedioxybenzyl)piperazine (MDBP) is a piperazine derivative with no medical use in the United States. It is not controlled domestically or controlled internationally under the Psychotropic Convention or the Single Convention on Narcotic Drugs.

Gammabutyrolactone (GBL) is used as a solvent and reagent in chemistry. GBL can be used in the synthesis of GHB, and can be converted to the central nervous system depressant drug Gamma hydroxybutyric acid (GHB) in the body after ingestion. As a precursor in the manufacture of GHB, GBL is controlled domestically as a List I chemical in the United States under the CSA. It is not controlled internationally under the Psychotropic Convention or the Single Convention on Narcotic Drugs.

1,4Butanediol is used as an industrial solvent for manufacturing and also used for the synthesis of GBL. After ingestion, 1,4Butanediol can also be converted to the central nervous depressant drug GHB. It has no medical use in the United States. 1,4Butanediol is not controlled domestically under the CSA in the United States, but is subject to controls in several states under State law.

III. Opportunity to Submit Domestic Information

As required by section 201(d)(2)(A) of the CSA (21 U.S.C. 811(d)(2)(A)), FDA, on behalf of HHS, invites interested persons to submit comments regarding the 10 named drugs. HHS will consider any received comments when it prepares a scientific and medical evaluation of these drugs. HHS will forward a scientific and medical evaluation of these drugs to WHO, through the Secretary of State, for WHO's consideration in deciding whether to recommend international control/ decontrol of any of these drugs. Such control could limit, among other things, the manufacture and distribution (import/export) of these drugs and could impose certain recordkeeping requirements on them.

HHS will not now make any recommendations to WHO regarding whether any of these drugs should be subjected to international controls. Instead, HHS will defer such consideration until WHO has made official recommendations to the Commission on Narcotic Drugs, which are expected to be made in early 2010. Any HHS position regarding international control of these drugs will be preceded by another Federal Register notice soliciting public comments as required by section 201(d)(2)(B) of the CSA.

IV. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding the drugs by (see DATES). This abbreviated comment period is necessary to allow sufficient time to prepare and submit the domestic information package by the deadline imposed by WHO. Two paper copies of any comments are to be submitted, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Governmentwide, electronic docket management system. Electronic comments or submissions will be
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accepted by FDA only through FDMS at http://www.regulations.gov.

Dated: August 22, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E820564 Filed 9408; 8:45 am]
BILLING CODE 416001S

FOR FURTHER INFORMATION CONTACT James R. Hunter, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 5146, Silver Spring, MD 209930002, 301 7963156, email: james.hunter@fda.hhs.gov.