73 FR 173 pgs. 51822-51823 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Veterinary Feed Directive
Type: NOTICEVolume: 73Number: 173Pages: 51822 - 51823
Docket number: [Docket No. FDA-2005-N-0474] (formerly Docket No. 2005N-0210)
FR document: [FR Doc. E8-20579 Filed 9-4-08; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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 cost-effectively 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:
| 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 | |||
| 1 There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
| 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 | |||
| 1 There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
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