[Federal Register Volume 68, Number 42 (Tuesday, March 4, 2003)]
[Notices]
[Page 10253]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-4977]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 93D-0398]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Guidance for Industry: ``Assessment of the 
Effects of Antimicrobial Drug Residues From Food of Animal Origin on 
the Human Intestinal Flora''

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 
April 3, 2003.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Stuart Shapiro, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information 
Resources Management (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.

Guidance for Industry: ``Assessment of the Effects of Antimicrobial 
Drug Residues From Food of Animal Origin on the Human Intestinal 
Flora''

    In the Federal Register of December 27, 2001 (66 FR 66910), FDA 
published a 60-day notice that requested comments to the proposed 
collection of information. In response, the agency received two 
submissions containing several comments. The commenters generally 
supported the pathway approach outlined in the draft guidance. The 
comments centered on the type of information that needs to be included 
and the endpoints that need to be addressed. Based on suggestions 
contained in the comments, this final guidance will eliminate the 
endpoint of metabolic activity of the intestinal flora (which was 
proposed in the draft guidance) and will consider human data to have 
more weight as evidence of adverse effect on the intestinal flora, when 
human data is available.
    Sponsors of new animal drugs must meet certain statutory 
requirements for new animal drug approval under section 512 of the 
Federal Food, Drug and Cosmetic Act (21 U.S.C. 360b). Among other 
things, the sponsor must demonstrate that the use of the drug is safe. 
Thus, when the Center for Veterinary Medicine (CVM) reviews new animal 
drug applications for drugs that will be used in food-producing 
animals, it must determine whether residues of the drug that may remain 
in human food derived from those animals would be harmful to humans. 
One possible harmful effect of residues of antimicrobial drugs that CVM 
considers in this determination is the possible effect of residues on 
human intestinal flora.
    This guidance document describes the pathway approach for assessing 
such effects. An assessment of the safety of antimicrobial drug 
residues in food is a major issue that we recommend be addressed by the 
sponsor of a new animal drug. For residues determined to have no 
antimicrobial activity against representatives of the human intestinal 
flora, an acceptable daily intake (ADI) is recommended to be calculated 
based on traditional toxicological studies. The burden hours required 
are reported and approved under OMB control number 0910-0032. However, 
the guidance recommends that additional information be provided for 
certain drugs if an assessment of microbiological safety determines 
that a new animal drug produces residues in foods that are 
micriobiologically active in the human colon. The likely respondents to 
this collection of information are sponsors of antimicrobial new animal 
drugs that will be used in food-producing animals. FDA estimates the 
burden of this collection of information as follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                      Annual
          Guidance           No. of Respondents   Frequency per     Total Annual       Hours per     Total Hours
                                                     Response         Responses        Response
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Assessments                          5           1                5                 14,110          70,550
 (microbiological studies)
 of safety of antimicrobial
 drug residues that are
 microbiologically active
 in the human colon
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The estimates in table 1 of this document resulted from discussions 
with sponsors of new animal drugs. The estimated burden includes 
studies, analysis of data, and writing the assessment. The number of 
respondents provided is based on current experience, however, the 
number may change in the future.

    Dated: February 21, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-4977 Filed 3-3-03; 8:45 am]
BILLING CODE 4160-01-S