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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Docket ID: [Docket No. FDA-2005-N-0474] (formerly Docket No. 2005N-0210)

NOTICE: NOTICES

DOCUMENT ACTION: Notice.

SUBJECT CATEGORY: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Veterinary Feed Directive

DATES: Fax written comments on the collection of information by October 6, 2008.

DOCUMENT 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.

SUMMARY: Agency Information Collection Activities; Proposals, Submissions, and Approvals,

SUPPLEMENTAL 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 Directive21 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 60day 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 Burden\1\ No. of Annual Frequency Total Annual Hours per 21 CFR Section Respondents per Response Responses Response Total Hours 558.6(a)(3) 15,000 25 375,000 .25 93,750 through
(a)(5)
558.6(d)(1)(i) 300 1 300 .25 75 through
(d)(1)(iii)
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 \1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2.Estimated Annual Recordkeeping Burden\1\ No. of Annual Frequency Total Annual 21 CFR Section Recordkeepers per Recordkeeping Records Hours per Record Total Hours 558.6(c)(1) 112,500 10 1,125,000 .0167 18,788 through
(c)(4)
558.6(e)(1) 5,000 75 375,000 .0167 6,263 through
(e)(4)
Total 117,500 .................... ................. ................. 25,051 \1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 51823]]

Dated: August 28, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E820579 Filed 9408; 8:45 am]
BILLING CODE 416001S

FOR FURTHER INFORMATION CONTACT Denver Presley, Jr., Office of Information Management (HFA710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 3017963793.