[Federal Register Volume 59, Number 117 (Monday, June 20, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-14963]
[[Page Unknown]]
[Federal Register: June 20, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94D-0146]
Evaluation of the Utility of Food Additives for Aquatic Animals;
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 a guideline entitled ``Guideline for the Evaluation of
the Utility of Food Additives in Diets Fed to Aquatic Animals''
prepared by the Center for Veterinary Medicine (CVM). The guideline
applies to studies intended to support a petition for the inclusion of
food additives in diets fed to aquatic animals.
DATES: Written comments may be submitted at any time. Received comments
will be considered to determine if further revision of the guideline is
necessary.
ADDRESSES: Submit written requests for single copies of the guideline
entitled ``Guideline for the Evaluation of the Utility of Food
Additives in Diets Fed to Aquatic Animals'' 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, or the contact person (address below). Send two self-addressed
adhesive labels to assist that office in processing your requests.
Submit written comments on the 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 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: John P. Machado, Center for Veterinary
Medicine (HFV-226), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1731.
SUPPLEMENTARY INFORMATION: The guideline entitled ``Guideline for the
Evaluation of the Utility of Food Additives in Diets Fed to Aquatic
Animals'' was developed for use by the aquaculture industry in
conducting studies intended to evaluate the effectiveness of food
additives. The guideline provides guidance to manufacturers and
scientists in the design and execution of utility studies which are a
required component of the food additive petition under 21 CFR 571.1.
This guideline provides considerations for protocol development;
recordkeeping; analytical assays for food additives; nutritional
content and preparation of experimental diets; physical characteristics
of diets; general experimental procedures; experimental design; and
investigator reports for laboratory and field trials.
Guidelines state practices or procedures that may be useful but are
not legal requirements. The guideline represents the agency's position
at the time of issuance. A person may follow the guideline or may
choose to follow alternate practices or procedures. If a person chooses
to use alternate practices or procedures, 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.
The 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 in any
way changed 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.
FDA will consider these comments in determining whether further
amendments to, or revisions of, the document are warranted. Two copies
of any comments should be submitted, except that individuals may submit
one copy, identified with the docket number found in brackets in the
heading of this document. The guideline and received comments may be
seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: June 15, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-14963 Filed 6-17-94; 8:45 am]
BILLING CODE 4160-01-F
