[Federal Register Volume 60, Number 47 (Friday, March 10, 1995)]
[Notices]
[Pages 13160-13161]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-6006]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 92D-0039]


Animal Drug Manufacturing; Revised Guideline; 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 the revised four-part guideline entitled, ``Animal Drug 
Manufacturing Guidelines, 1994'' prepared by the Center for Veterinary 
Medicine (CVM). These guidelines describe the data and information for 
the manufacturing portions of abbreviated new animal drug applications, 
new animal drug applications, and supplements for pharmaceutical dosage 
forms.

DATES: Written comments on these guidelines may be submitted at any 
time.

ADDRESSES: Submit written requests for single copies of the revised 
guidelines entitled, ``Animal Drug Manufacturing Guidelines, 1994: I. 
Pilot Batch Manufacture, II. Tentative Expiration Dates, III. 
Manufacturing Sites, and IV. New Animal Drug Substance Sources'' 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 revised guidelines 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. A copy of the 
revised guidelines and received comments may be seen at the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: William G. Marnane, Center for 
Veterinary Medicine (HFV-143), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-0678.
SUPPLEMENTARY INFORMATION: The Food and Drug Administration (FDA) is 
announcing the availability of the revised four-part guideline 
entitled, ``Animal Drug Manufacturing Guidelines, 1994: I. Pilot Batch 
Manufacture, II. Tentative Expiration Dates, III. Manufacturing Sites, 
and IV. New Animal Drug Substance Sources'' prepared by CVM. These 
guidelines are intended to be used by both pioneer and generic 
manufacturers of veterinary drug products so that they are informed of 
the type of information that FDA believes will provide an acceptable 
submission to support the manufacturing requirements for new animal 
drug applications, abbreviated new animal drug applications, and 
supplemental applications for pharmaceutical dosage forms. In the 
Federal Register of August 21, 1992 (57 FR 37979), FDA issued a notice 
of availability of the four CVM guidelines entitled, ``Animal Drug 
Manufacturing Guidelines, 1992.'' Comments by the public were requested 
to be submitted at any time so that future revisions of the guidelines 
could be developed in consideration of the remarks.
    The agency received three comments on the 1992 guidelines. The 
comments came from two drug manufacturers and one trade association. 
The 1992 guidelines have been revised as a result of these comments and 
from internal discussions within CVM.
    Many editorial comments were made about all four guidelines. The 
editorial comments were adopted in the revised guidelines when the 
agency deemed that they were appropriate and provided clarification. 
Technical comments about ``Guideline I. Pilot Batch Manufacture'' 
focused on the CVM recommendations for the size of the test batch and 
the type of equipment or production facility that is appropriate for 
manufacturing test lots. A suggestion was made to allow bridging data 
in cases where the recommendations for batch size, production facility, 
equipment, and standard operating procedures are not practicable. 
Technical comments about ``Guideline II. Tentative Expiration Dates'' 
centered on a clarification of the definition of exaggerated storage 
conditions for different dosage forms and the application of expiration 
dating to all manufacturing sites for one drug product. Technical 
comments about ``Guideline III. Manufacturing Sites'' included 
criticisms of the definitions of the different types of manufacturing 
sites, the option for the agency to request bioequivalence data, and 
the appropriate location of sterile process validation data in the drug 
application. Technical comments about ``Guideline IV. New Animal Drug 
Substance Sources'' were made regarding the definitions of primary and 
alternate sources of the new animal drug substance, test batch and 
stability data for supplemental applications, and bioequivalence data 
requirements for mastitis products. All of these comments were 
considered in the revision of the manufacturing guidelines.
    One of the most significant changes to the 1992 guidelines is to 
allow bridging data to be submitted when the recommendations for batch 
size, production facility, equipment, and standard operating procedures 
for pilot [[Page 13161]] batches are not practicable. The sponsor may 
create an alternative plan to that recommended in order to compare the 
bioavailability and stability characteristics of the test and 
production batch. Another major change to the guidelines is the 
provision of an alternate means by which sponsors may meet the 
supplemental application recommendations for alternate manufacturing 
sites and alternate sources of bulk drug substance when multiple NADA's 
and ANADA's are affected. The sponsor may request that pilot batches of 
representative drug products within the same dosage form class be 
manufactured instead of producing pilot batches of all affected drug 
products.
    These ``Animal Drug Manufacturing Guidelines, 1994'' are not 
intended to be individual stand-alone documents. Much of the 
information presented in one guideline may be equally important to the 
correct interpretation of the other guidelines. Therefore, all four 
guidelines are being issued concurrently.
    Guidelines state procedures or practices that may be useful to the 
persons to whom they are directed, but are not legal requirements. The 
agency is in the process of revising Secs. 10.85(d) and 10.90(b) (21 
CFR 10.85(d) and 10.90(b)). Therefore, these guidelines are not being 
issued under authority of present Secs. 10.85(d) and 10.90(b). A person 
may follow the guideline 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. A guideline does not 
bind the agency, and it does not create or confer any rights, 
privileges, or benefits for or on any person. When a guideline states a 
requirement imposed by statute or regulation, however, the requirement 
is law and its force and effect are not changed in any way by virtue of 
its inclusion in the guideline.
    Interested persons may, at any time, submit to the Dockets 
Management Branch (address above) written comments on the guideline. 
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 guideline 
and received comments are available for public examination in the 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.
    Received comments will be considered to determine if further 
revision of the guideline is necessary.

    Dated: March 6, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-6006 Filed 3-9-95; 8:45 am]
BILLING CODE 4160-01-F