[Federal Register Volume 60, Number 59 (Tuesday, March 28, 1995)]
[Notices]
[Pages 15933-15934]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-7513]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94D-0356]


Protocol Development for Clinical Effectiveness and Target Animal 
Safety Trials; Availability of Guideline

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 guideline entitled, ``Protocol Development 
Guideline for Clinical Effectiveness and Target Animal Safety Trials'' 
prepared by the Center for Veterinary Medicine (CVM). This guideline 
describes a suggested systematic approach to be followed when designing 
and reporting effectiveness and target animal safety studies that are 
conducted to provide data to support animal drug approvals.

DATES: Written comments may be submitted at any time.

[[Page 15934]] ADDRESSES: Submit written requests for single copies of 
the guideline entitled, ``Protocol Development Guideline for Clinical 
Effectiveness and Target Animal Safety Trials'' 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 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: Larry Ventura, Center for Veterinary 
Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1647.
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of the 
guideline entitled, ``Protocol Development Guideline for Clinical 
Effectiveness and Target Animal Safety Trials'' prepared by CVM. The 
guideline is intended to be used by clinical investigators, study 
monitors, and sponsors, when designing investigations of effectiveness 
and target animal safety for animal drug approval and may be used when 
submitting the final reports of these trials. This guideline was 
written in response to a request by the animal health industry for 
guidance on facilitating protocol development and expediting CVM's 
review of the submitted protocols, and it should help sponsors to 
include all essential components of the study in the protocol. More 
uniform reports should allow a systematic, orderly review of the data 
by CVM. The goals of the protocol development guideline are to:
    1. Suggest a uniform system for writing study protocols,
    2. Provide a reference of essential items that should be considered 
for inclusion in a study protocol,
    3. Facilitate the development of complete study protocol(s) by the 
author(s),
    4. Design more user friendly protocols for investigator(s),
    5. Enable FDA reviewers to evaluate study protocols more quickly 
and convey their comments in terms more easily understood by the 
sponsor, and
    6. Reduce the number of essential revisions of study protocols.
    The guideline offers a complete outline of the components necessary 
for a well-designed study so that CVM and industry have a common 
reference point. This uniform approach will facilitate the drafting of 
study reports by the sponsor and their subsequent review by CVM. The 
contents of this guideline are neither all inclusive nor will all items 
listed be applicable to all study protocols. It is the responsibility 
of the sponsor to ensure that the essential components of a study are 
included in their protocol. Guidelines state procedures or practices 
that may be useful to the persons to whom they are directed, but are 
not legal requirements. 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.
    Guidelines are generally issued under Secs. 10.85(a) and 
10.90(b)(21 CFR 10.85(a) and 10.90(b)). The agency is now in the 
process of revising Secs. 10.85(a) and 10.90(b). Therefore, this 
guideline is not being issued under the authority of Secs. 10.85(a) and 
10.90(b). 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 written comments on the 
guideline to the Dockets Management Branch (address above). 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, at the Dockets Management Branch.

    Dated: March 16, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-7513 Filed 3-27-95; 8:45 am]
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