Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Notices 51823 

Dated: August 28, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–20579 Filed 9–4–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0448] 

International Drug Scheduling; 

Convention on Psychotropic 

Substances; Single Convention on 

Narcotic Drugs; Gammahydroxybutyric acid; Ketamine; 

Dextromethorphan; Nbenzylpiperazine; 1-(3- 

trifluoromethylphenyl)piperazine; 1-(3- 

chlorophenyl)piperazine; 1-(4- 

Methoxyphenyl)piperazine; 1-(3,4- 

methylenedioxybenzyl)piperazine; 

Gamma-butyrolactone; 1,4-Butanediol 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

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). 

DATES: Submit written or electronic 

comments by October 6, 2008. 

ADDRESSES: Submit written comments 

to the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. 

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 20993-0002, 301 796–

3156, e-mail: james.hunter@fda.hhs.gov. 

SUPPLEMENTARY 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 Secretary-General) and 

provide the Secretary-General 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 Thirty-fifth Expert 

Committee on Drug Dependence will meet 

from 20 to 23 April 2009 to review the 

following substances: 

1. Gamma-hydroxybutyric acid (GHB) 

2. Ketamine INN 

3. Dextromethorphan pINN 

4. N-benzylpiperazine (BZP) 

5. 1-(3-trifluoromethylphenyl)piperazine 

(TFMPP) 

6. 1-(3-chlorophenyl)piperazine (mCPP) 

7. 1-(4-Methoxyphenyl)piperazine 

(MeOPP) 

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

(MDBP) 

9. Gamma-butyrolactone 

10. 1,4-Butanediol 

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. GAMMA-HYDROXYBUTYRIC 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 off-label 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 

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51824 Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Notices 

1Harmful 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. 

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) 

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 

(Gamma-hydroxybutyrate is in Schedule IV 

of the Convention on Psychotropic 

Substances of 1971 currently.) 

4.1 If gamma-hydroxybutyric 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 off-label 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 off-label 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). 

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Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Notices 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. N-BENZYLPIPERAZINE (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 off-label 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-(3-TRIFLUOROMETHYL 

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 off-label 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) 

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51826 Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Notices 

3.4 Any additional information with regard 

to questions 3.2 and 3.3. 

6. 1-(3-CHLOROPHENYL)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 off-label 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-(4-METHOXYPHENYL)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 off-label 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-(3,4- 

METHYLENEDIOXYBENZYL)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 off-label 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 

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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. 

9. GAMMA-BUTYROLACTONE 

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 off-label 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. 1,4-BUTANEDIOL 

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 off-label 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? 

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51828 Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Notices 

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 

Gamma-hydroxybutyric acid (GHB) is 

classified as a central nervous system 

depressant. In 2002, FDA approved a 

GHB-containing 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 

pre-reviewed GHB at its thirty-fourth 

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 thirty-fourth 

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. 

N-benzylpiperazine (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-(3-trifluoromethylphenyl)piperazine 

(TFMPP) is a piperazine-based 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-(3-chlorophenyl)piperazine (mCPP) 

is a piperazine-based 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-(4-Methoxyphenyl)piperazine 

(MeOPP) is a piperazine-based 

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-(3,4- 

methylenedioxybenzyl)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. 

Gamma-butyrolactone (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. 

1,4-Butanediol is used as an industrial 

solvent for manufacturing and also used 

for the synthesis of GBL. After ingestion, 

1,4-Butanediol can also be converted to 

the central nervous depressant drug 

GHB. It has no medical use in the 

United States. 1,4-Butanediol 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 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

mstockstill on PROD1PC66 with NOTICES

Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Notices 51829 

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. E8–20564 Filed 9–4–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0038] 

Peripheral and Central Nervous 

System Drugs Advisory Committee; 

Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Peripheral and 

Central Nervous System Drugs Advisory 

Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on October 23, 2008, from 8 a.m. 

to 5 p.m. 

Location: Hilton Washington DC/ 

Silver Spring, The Ballrooms, 8727 

Colesville Rd., Silver Spring, MD. The 

hotel telephone number is 301–589–

5200. 

Contact Person: Diem-Kieu Ngo, 

Center for Drug Evaluation and Research 

(HFD–21), Food and Drug 

Administration, 5600 Fishers Lane (for 

express delivery, 5630 Fishers Lane, rm. 

1093), Rockville, MD 20857, 301–827–

7001, FAX: 301–827–6776, e-mail: 

Diem.Ngo@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572) in the 

Washington, DC area), code 

3014512543. Please call the Information 

Line for up-to-date information on this 

meeting. A notice in the Federal 

Register about last minute modifications 

that impact a previously announced 

advisory committee meeting cannot 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check the agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn 

about possible modifications before 

coming to the meeting. 

Agenda: The Committee will discuss 

the clinical development of 

radionuclide imaging products for the 

detection of amyloid to assist in the 

diagnosis of Alzheimer’s Disease. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ohrms/ 

dockets/ac/acmenu.htm, click on the 

year 2008 and scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before October 8, 2008. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. and 2 p.m. Those desiring to make 

formal oral presentations should notify 

the contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before September 30, 2008. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

October 1, 2008. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Diem-Kieu 

Ngo at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/oc/advisory/ 

default.htm for procedures on public 

conduct during advisory committee 

meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: August 27, 2008. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E8–20577 Filed 9–4–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0369] (formerly 

Docket No. 2007D–0168) 

Publication of Guidances for Industry 

Describing Product-Specific 

Bioequivalence Recommendations 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of additional draft and 

revised draft product-specific 

bioequivalence (BE) recommendations. 

The recommendations provide productspecific guidance on the design of BE 

studies to support abbreviated new drug 

applications (ANDAs). In the Federal 

Register of May 31, 2007 (72 FR 30388), 

FDA announced the availability of a 

draft guidance for industry, 

‘‘Bioequivalence Recommendations for 

Specific Products,’’ explaining the 

process that would be used to make 

product-specific BE recommendations 

available to the public on FDA’s Web 

site. The BE recommendations 

identified in this notice were developed 

using the process described in that 

guidance. 

DATES: Submit written or electronic 

comments on the draft product-specific 

BE recommendations listed in this 

notice by December 4, 2008. 

ADDRESSES: Submit written requests for 

single copies of the individual BE 

guidances to the Division of Drug 

Information, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, rm. 2201, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit written comments on the draft 

product-specific BE recommendations 

to the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. See the 

mstockstill on PROD1PC66 with NOTICES