[Federal Register Volume 68, Number 153 (Friday, August 8, 2003)]
[Notices]
[Page 47331]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-20200]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1993P-0174]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Requirements for Liquid Medicated Animal Feed 
and Free-Choice Medicated Animal Feed

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

SUMMARY: 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.

DATES:  Submit written comments on the collection of information by 
September 8, 2003.

ADDRESSES: 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.

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.

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.

Waiver From Labeling Requirements for New Animal Drugs Intended for Use 
in Liquid Medicated Animal Feed

    Proposed Sec.  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.

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                                                                          Annual
                                                              No. of    Frequency    Total      Hours     Total
                 Proposed 21 CFR Section                   Respondents     per       Annual      per      Hours
                                                                        Responses  Responses  Response
----------------------------------------------------------------------------------------------------------------
558.5(i)                                                           1           1          1         5         5
----------------------------------------------------------------------------------------------------------------
\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.

    Dated: August 4, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-20200 Filed 8-7-03; 8:45 am]
BILLING CODE 4160-01-S