[Federal Register Volume 65, Number 222 (Thursday, November 16, 2000)]
[Notices]
[Pages 69317-69318]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-29325]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1435]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Substantial Evidence of Effectiveness of New 
Animal Drugs

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
December 18, 2000.

ADDRESSES: Submit written comments on the collection of information to 
Office of Information and Regulatory Affairs, OMB, New Executive Office 
Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: Wendy 
Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

[[Page 69318]]

Substantial Evidence of Effectiveness of New Animal Drugs--21 CFR 
Part 514--(OMB Control No. 0910-0356)--Extension

    Description: Congress enacted the Animal Drug Availability Act of 
1996 (ADAA) (Public Law 104-250) on October 9, 1996. As directed by the 
ADAA, FDA published a final rule July 28, 1999 (64 FR 40746), amending 
part 514 (21 CFR part 514) to further define substantial evidence in a 
manner that encourages the submission of new animal drug applications 
(NADA's), supplemental NADA's and encourages dose range labeling. 
Substantial evidence is the standard that a sponsor must meet to 
demonstrate the effectiveness of a new animal drug for its intended 
uses under the conditions of use suggested in its proposed labeling. It 
is defined as evidence consisting of one or more adequate and well-
controlled studies, such as a study in a target species, study in 
laboratory animals, field study, bioequivalence study, or an in vitro 
study, on the basis of which it could fairly and reasonably be 
concluded by qualified experts that the new animal drug will have the 
effect it purports or is represented to have under the conditions of 
use prescribed, recommended, or suggested in the labeling or proposed 
labeling thereof. The provisions of Sec. 514.4(a) provide the agency 
with greater flexibility to make case-specific scientific 
determinations regarding the number and types of adequate and well-
controlled studies that will provide, in an efficient manner, 
substantial evidence that a new animal drug is effective. The agency 
believes this regulation over time, will reduce the number of adequate 
and well-controlled studies necessary to demonstrate the effectiveness 
of certain combination new animal drugs, will eliminate the need for an 
adequate and well-controlled dose titration study, and may, in limited 
instances, reduce or eliminate the number of adequate and well-
controlled field investigations necessary to demonstrate by substantial 
evidence the effectiveness of a new animal drug.
    Description of Respondents: Respondents to this collection of 
information are persons and businesses, including small businesses. In 
the Federal Register of August 16, 2000 (65 FR 49989), the FDA 
published a 60-day notice concerning the proposed extension of this 
collection of information and requested comments. No comments were 
received on the estimated annual reporting burden. We therefore believe 
the total burden estimate of 544,036 hours for the annual reporting and 
recordkeeping burden should remain unchanged.
    FDA estimates the burden of the collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden \1\
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                         No. of        Annual frequency     Total annual        Hours per
  21 CFR section      respondents        per response        responses           response         Total hours
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      514.4(a)           190                  4.5              860                632.6         544,036
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The estimated annual reporting burden is based on consultation by 
the Center for Veterinary Medicine with several of the major research 
and development firms that conduct the majority of studies submitted to 
establish substantial evidence of effectiveness of new animal drugs and 
agency records.

    Dated: November 9, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-29325 Filed 11-15-00; 8:45 am]
BILLING CODE 4160-01-F