[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