Post by Thom on Aug 3, 2004 10:30:06 GMT -7
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Tylosin Tartrate for Foulbrood in Honeybees; Availability of Data
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of effectiveness, target animal safety, human food safety,
and environmental safety data that may be used in support of a new
animal drug application (NADA) or supplemental NADA for use of tylosin
tartrate for the control of American foulbrood (Paenibacillus larvae)
in honeybees. The data, contained in Public Master File (PMF) 5783,
were compiled under National Research Support Project 7 (NRSP-7), a
national agricultural research program for obtaining clearances for use
of new drugs in minor animal species and for minor uses.
ADDRESSES: Submit NADAs or supplemental NADAs to the Document Control
Unit (HFV-199), Center for Veterinary Medicine, Food and Drug
Administration, 7500 Standish Pl., Rockville, MD 20855.
FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail:
jgotthar@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: Tylosin tartrate soluble powder used for the
control of American foulbrood (P. larvae) in honeybees is a new animal
drug under section 201(v) of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 321(v)). As a new animal drug, tylosin tartrate is
subject to section 512 of the act (21 U.S.C. 360b) , requiring that its
uses be the subject of an approved NADA or supplemental NADA. Honeybees
are a minor species under Sec. 514.1(d)(1)(ii) (21 CFR
514.1(d)(1)(ii)).
The NRSP-7 Project, western region, University of California,
Davis, CA 95616, has provided target animal safety, effectiveness,
human food safety, and environmental safety data for use of tylosin
tartrate soluble powder for the control of American foulbrood in
honeybees. These data, contained in PMF 5783, were reviewed by FDA and
found satisfactory to support those aspects of an original or
supplemental NADA.
Sponsors of NADAs or supplemental NADAs may, without further
authorization, reference the PMF 5783 to support approval of an
application filed under Sec. 514.1(d). An NADA or supplemental NADA
must include, in addition to reference to the PMF, animal drug labeling
and other information needed for approval, such as: Data supporting
extrapolation from a major species in which the drug is currently
approved or authorized reference to such data; and data concerning
manufacturing methods, facilities, and controls. Persons desiring more
information concerning PMF 5783 or requirements for approval of an NADA
or supplement may contact Joan C. Gotthardt (see FOR FURTHER
INFORMATION CONTACT).
Food and Drug Administration
Tylosin Tartrate for Foulbrood in Honeybees; Availability of Data
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of effectiveness, target animal safety, human food safety,
and environmental safety data that may be used in support of a new
animal drug application (NADA) or supplemental NADA for use of tylosin
tartrate for the control of American foulbrood (Paenibacillus larvae)
in honeybees. The data, contained in Public Master File (PMF) 5783,
were compiled under National Research Support Project 7 (NRSP-7), a
national agricultural research program for obtaining clearances for use
of new drugs in minor animal species and for minor uses.
ADDRESSES: Submit NADAs or supplemental NADAs to the Document Control
Unit (HFV-199), Center for Veterinary Medicine, Food and Drug
Administration, 7500 Standish Pl., Rockville, MD 20855.
FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail:
jgotthar@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: Tylosin tartrate soluble powder used for the
control of American foulbrood (P. larvae) in honeybees is a new animal
drug under section 201(v) of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 321(v)). As a new animal drug, tylosin tartrate is
subject to section 512 of the act (21 U.S.C. 360b) , requiring that its
uses be the subject of an approved NADA or supplemental NADA. Honeybees
are a minor species under Sec. 514.1(d)(1)(ii) (21 CFR
514.1(d)(1)(ii)).
The NRSP-7 Project, western region, University of California,
Davis, CA 95616, has provided target animal safety, effectiveness,
human food safety, and environmental safety data for use of tylosin
tartrate soluble powder for the control of American foulbrood in
honeybees. These data, contained in PMF 5783, were reviewed by FDA and
found satisfactory to support those aspects of an original or
supplemental NADA.
Sponsors of NADAs or supplemental NADAs may, without further
authorization, reference the PMF 5783 to support approval of an
application filed under Sec. 514.1(d). An NADA or supplemental NADA
must include, in addition to reference to the PMF, animal drug labeling
and other information needed for approval, such as: Data supporting
extrapolation from a major species in which the drug is currently
approved or authorized reference to such data; and data concerning
manufacturing methods, facilities, and controls. Persons desiring more
information concerning PMF 5783 or requirements for approval of an NADA
or supplement may contact Joan C. Gotthardt (see FOR FURTHER
INFORMATION CONTACT).