[Federal Register Volume 60, Number 40 (Wednesday, March 1, 1995)]
[Notices]
[Page 11097]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-4962]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 94D-0401]


Revised Bioequivalence Guideline; Draft; 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 draft guideline entitled ``Bioequivalence Guideline 
(Draft) 1994'' prepared by the Center for Veterinary Medicine (CVM). 
The draft guideline, which is a revision of the 1990 version, covers 
general considerations, blood level studies, pharmacologic end-points, 
clinical end-points, and human food safety. The draft guideline is 
intended to assist sponsors of new animal drug applications in the 
submission of data to support approval of these applications.

DATES: Written comments by May 30, 1995.

ADDRESSES: Submit written requests for single copies of the draft 
guideline entitled ``Bioequivalence Guideline (Draft) 1994'' to the 
Communications and Education Branch (HFV-12), Center for Veterinary 
Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, 
MD 20855, 301-594-1756. Send two self-addressed adhesive labels to 
assist that office in processing your requests. Submit written comments 
on the draft guideline 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 
draft 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.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1643.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of the 
draft guideline entitled ``Bioequivalence Guideline (Draft) 1994.'' The 
draft is based on an April 1990 bioequivalence guideline and a 
consensus of reports from panel presentations at the 1993 Veterinary 
Drug Bioequivalence Workshop held in Rockville, MD. Major new topics 
addressed in the draft guideline include: Bioequivalence overdose 
studies, testing for multiple strength solid oral dosage forms, assay 
considerations, area under the curve and maximum blood concentration as 
pivotal parameters, and blood level studies with good laboratory 
practice tissue residue depletion for generic products for food 
animals.
    Guidelines are generally issued under Secs. 10.85(d) and 10.90(b) 
(21 CFR 10.85(d) and 10.90(b)), which provide for the use of guidelines 
to establish procedures or standards of general applicability that are 
not legal requirements but that are acceptable to FDA. The agency is 
now in the process of considering whether to revise Secs. 10.85(d) and 
10.90(b). Therefore, if the agency issues this guideline in final form, 
it would not be issued under the authority of Secs. 10.85(d) and 
10.90(b), and would not create or confer any rights, privileges, or 
benefits for or on any person, nor would it operate to bind FDA in any 
way. 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, on or before May 30, 1995, submit to the 
Dockets Management Branch (address above) written comments on the draft 
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 
draft guideline and received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.
    Received comments will be considered to determine whether further 
amendments to, or revisions of, the draft guideline are warranted.

    Dated: February 23, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-4962 Filed 2-28-95; 8:45 am]
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