Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Submit written comments on the collection of information by September 8, 2003.
OMB is still experiencing significant delays in the regular mail, including 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.
Waiver From Labeling Requirements for New Animal Drugs Intended for Use in Liquid Medicated Animal Feed
Proposed § 558.5(i) specifies procedures for obtaining a waiver from labeling requirements for certain drugs intended for use in animal feed or drinking water but not approved for use in liquid medicated feed. The request for waiver must include a copy of the product label; a description of the formulation; and information to establish that the physical, chemical, or other properties of the product are such that diversion to use in liquid medicated feeds is unlikely. This information would be collected if the manufacturer or sponsor chose not to include the required warning “FOR USE IN_____ ONLY, NOT FOR USE IN LIQUID MEDICATED FEEDS” on its product label. The sponsor or manufacturers would then need to satisfy the requirements of the waiver section of the regulation. All other data collections are covered under OMB control number 0910-0032.
Medicated feed manufacturing facilities and sponsors of new animal drugs used in the manufacture of medicated feed.
|Proposed 21 CFR Section||No. of Respondents||Annual Frequency per Responses||Total Annual Responses||Hours per Response||Total Hours|
|1 There are no capital costs or operating and maintenance costs associated with this collection of information.|
The burden estimate for this reporting requirement was derived from data by our Division of Animal Feeds, Center for Veterinary Medicine, FDA. Only one respondent was used in these figures because although this particular waiver has been part of the regulations since 1973, it has never been utilized. We estimated it would take 5 hours to compile the required information because of the time necessary to explain why the drug would not be diverted to use in liquid feed.Start Signature
Dated: August 4, 2003.
Assistant Commissioner for Policy.
[FR Doc. 03-20200 Filed 8-7-03; 8:45 am]
BILLING CODE 4160-01-S