[Federal Register Volume 61, Number 35 (Wednesday, February 21, 1996)]
[Notices]
[Page 6644]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-3733]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 92D-0287]
Generic Animal Drug Products Containing Fermentation-Derived Drug
Substances; Guidance; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance document entitled ``Guidance on Generic
Animal Drug Products Containing Fermentation-Derived Drug Substances.''
The guidance is intended to provide sponsors with information that will
enable them to submit complete and well-organized chemistry and
manufacturing and control information for applications for generic
animal drug products containing fermentation-derived drug substances.
FDA invites interested persons to submit written comments on this
guidance.
DATES: Written comments on this guidance document may be submitted at
any time.
ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Guidance on Generic Animal Drug Products Containing
Fermentation-Derived Drug Substances'' to the Communications and
Education Branch (HFV-12), Center for Veterinary Medicine, Food and
Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-
1755. Send two self-addressed adhesive labels to assist that office in
processing your requests. Submit written comments on the guidance
document to the Dockets Management Branch (HFA-305), Food and Drug
Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.
Requests and comments should be identified with the docket number found
in brackets in the heading of this document. The guidance document and
received comments are available for public examination in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for
Veterinary Medicine (HFV-142), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-2701.
SUPPLEMENTARY INFORMATION: The sponsor of a new animal drug application
(NADA) is required to submit to FDA the chemistry and manufacturing and
control information necessary to support their submission. This
information is generally described in 21 CFR 514.1 for original NADA's
and in 21 CFR 514.8 for supplements to approved NADA's. The chemistry
and manufacturing and control information requirements are identical
for original abbreviated new animal drug applications (ANADA's) and
supplements to approved ANADA's.
Additionally, the manufacturing process must meet current good
manufacturing practice (CGMP) regulations. The CGMP requirements are
described in 21 CFR parts 210 and 211 for pharmaceutical dosage forms
and in 21 CFR part 226 for Type A medicated articles.
The Center for Veterinary Medicine believes that the guidance
document will provide sponsors with information that will enable them
to submit complete and well-organized chemistry and manufacturing and
control data and information for ANADA's for animal drug products
containing fermentation-derived drug substances.
In contrast to the general description of requirements in the Code
of Federal Regulations, the guidance document provides specific
manufacturing information recommendations for antibiotic new drug
substances, biomass drug substances, and the finished drug product. In
addition, it provides guidance for conducting comparison studies
between the generic drug product and the pioneer drug product. The
guidance document also describes acceptable fermentation organisms,
antibiotic new drug substances, and biomass drug substances.
A person may follow the guidance or may choose to follow alternate
procedures or practices. If a person chooses to use alternate
procedures or practices, that person may wish to discuss the matter
further with the agency to prevent an expenditure of money and effort
on activities that may later be determined to be unacceptable to FDA.
Although this guidance document does not bind the agency or the public,
and it does not create or confer any rights, privileges, or benefits
for or on any person, it represents FDA's current thinking on generic
animal drug products containing fermentation-derived substances. When a
guidance document states a requirement imposed by statute or
regulation, the requirement is law and its force and effect are not
changed in any way by virtue of its inclusion in the guidance.
Interested persons may, at any time, submit to the Dockets
Management Branch (address above) written comments on the guidance
document. Two copies of any comments are to be submitted, except that
individuals may submit one copy. Comments are to be identified with the
docket number found in brackets in the heading of this document. The
guidance document and received comments are available for public
examination in the Dockets Management Branch between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: February 13, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-3733 Filed 2-20-96; 8:45 am]
BILLING CODE 4160-01-F