51822 Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Notices 

Dated: August 28, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–20578 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–2005–N–0474] (formerly 

Docket No. 2005N–0210) 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Veterinary Feed 

Directive 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by October 6, 

2008. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974, or e-mailed to 

baguilar@omb.eop.gov. All comments 

should be identified with the OMB 

control number 0910–0363. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3793. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Veterinary Feed Directive—21 CFR Part 

558 (OMB Control Number 0910–

0363)—Extension 

With passage of the Animal Drug 

Availability Act, Congress enacted 

legislation establishing a new class of 

restricted feed use drugs called 

Veterinary Feed Directive (VFD) drugs. 

The VFD class of drugs may be 

distributed without involving State 

pharmacy laws. Although controls on 

the distribution and use of VFD drugs 

are similar to controls for prescription 

drugs regulated under section 503(f) of 

the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 503(f)), the implementing 

VFD regulation under section 558.6 (21 

CFR 558.6) is tailored to the unique 

circumstances relating to the 

distribution of medicated feeds. The 

content of the VFD is spelled out in the 

regulation. All distributors of medicated 

feed containing VFD drugs must notify 

FDA of their intent to distribute, and the 

distribution records of all medicated 

feeds containing VFD must be 

maintained. The VFD regulation ensures 

the protection of the public health while 

enabling animal producers to obtain and 

use needed drugs as efficiently and costeffectively as possible. 

In the Federal Register of June 5, 2008 

(73 FR 32029), FDA published a 60-day 

notice requesting public comment on 

the information collection provisions. 

No comments were received. 

FDA estimates the burden for this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

558.6(a)(3) through (a)(5) 15,000 25 375,000 .25 93,750 

558.6(d)(1)(i) through (d)(1)(iii) 300 1 300 .25 75 

558.6(d)(1)(iv) 20 1 20 .25 5 

558.6(d)(2) 1,000 5 5,000 .25 1,250 

514..1(b)(9) 1 1 1 3.00 3 

Total 16,321 95,083 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

558.6(c)(1) through (c)(4) 112,500 10 1,125,000 .0167 18,788 

558.6(e)(1) through (e)(4) 5,000 75 375,000 .0167 6,263 

Total 117,500 25,051 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

mstockstill on PROD1PC66 with NOTICES

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 

mstockstill on PROD1PC66 with NOTICES