Food and Drug Administration, HHS.
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.
Fax written comments on the collection of information by October 28, 2005.
OMB is still experiencing significant delays in the regular mail, inlcuding first class and express mail, and messenger deliveries are not being accepted. 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: Fumie Yokota, Desk Officer for FDA, FAX: 202-395-6974.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472.End Further Info End Preamble Start 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 Directive—21 CFR Part 558 (OMB Control Number 0910-0363)—Extension
With the passage of the Animal Drug Availability Act (ADAA), Congress enacted legislation establishing a new class of restricted feed use drugs called Veterinary Feed Directive, which can be distributed without involving State pharmacy laws. Although controls on the distribution and use of VFD drugs are similar to those for prescription drugs regulated under section 503(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(f)), the implementing VFD regulation under 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 feeds containing VFD drugs must notify FDA of their intent to distribute, and records must be maintained of the distribution of all medicated feeds containing VFD drugs. The VFD regulation ensures the protection of public health while enabling animal producers to obtain and use needed drugs as efficiently and cost-effectively as possible.Start Printed Page 56708
In the Federal Register of June 10, 2005 (70 FR 33907), FDA published a 60-day notice soliciting comments on this collection of information. In response to this notice, no comments were received.
The respondents for VFD drugs are Veterinarians, distributors of animal feeds containing VFD drugs, and clients utilizing medicated feeds containing VFD drugs.
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 558.6(a)(5)||15,000||25||375,000||0.25||93,750|
|558.6(d)(1)(i) through 558.6(d)(1)(iii)||1,500||1||500||0.25||125|
|1 There are no capital costs or operating and maintenance cost associated with this collection of information|
|21 CFR||No. of Recordkeepers||Annual Frequency per Recordkeeper||Total Annual Records||Hours per Record||Total Hours|
|558.6(c)(1) through 558.6(c)(4)||112,500||10||1,125,000||.0167||18,788|
|558.6(e)(1) through 558.6(e)(3)||5,000||75||375,000||.0167||6,263|
|1 There are no capitals cost or operating and maintenance cost associated with this collection of information.|
The estimate of the times required for record preparation and maintenance is based on agency communication with industry. Other information needed to calculate the total burden hours are derived from agency records and experience.Start Signature
Dated: September 22, 2005.
Assistant Commissioner for Policy.
[FR Doc. 05-19393 Filed 9-27-05; 8:45 am]
BILLING CODE 4160-01-S