Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Notices 51821 

the document identifier or OMB control 

number. To be assured consideration, 

comments and recommendations must 

be submitted in one of the following 

ways by November 4, 2008: 

1. Electronically. You may submit 

your comments electronically to http:// 

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’

to find the information collection 

document(s) accepting comments. 

2. By regular mail. You may mail 

written comments to the following 

address: 

CMS, Office of Strategic Operations and 

Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number lllll, 

Room C4–26–05, 

7500 Security Boulevard, 

Baltimore, Maryland 21244–1850. 

Dated: August 29, 2008. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E8–20686 Filed 9–4–08; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0312] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Extralabel Drug 

Use in Animals 

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 0910–0325. 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. 

Extralabel Drug Use in Animals—21 

CFR part 530 (OMB Control Number 

0910–0325)—Extension 

Under part 530 (21 CFR Part 530), a 

veterinarian is permitted to prescribe 

the extralabel use of approved new 

animal drugs. Section 530.22 (b) of the 

implementing regulations permits FDA, 

if it finds there is a reasonable 

probability that the extralabel use of an 

animal drug may present a risk to the 

public health, to: (1) Establish a safe 

level for a residue from the extralabel 

use of the drug, and (2) require the 

development of an analytical method for 

the detection of residues above that 

established safe level. To date, FDA has 

not established a safe level for a residue 

from the extralabel use of any new 

animal drug and therefore has not 

required the development of analytical 

methodology. However, the agency 

believes that there may be instances 

when analytical methodology will be 

required. Thus, FDA is estimating the 

reporting burden based on two methods 

being required annually. The 

requirement to establish an analytical 

method may be fulfilled by any 

interested person. The agency believes 

that the sponsor of the drug will be 

willing to develop the method in most 

cases. Alternatively, FDA, the sponsor, 

and perhaps a third party may 

cooperatively arrange for method 

development. The respondents may be 

sponsors of new animal drugs, State, or 

Federal government, or individuals. 

In the Federal Register of June 3, 2008 

(73 FR 31693), FDA published a 60-day 

notice requesting public comment on 

the information collection provisions. 

No comments were received. 

FDA estimates the burden of 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 

530.22(b) 2 1 2 4,160 8,320 

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

mstockstill on PROD1PC66 with NOTICES

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