[Federal Register Volume 65, Number 159 (Wednesday, August 16, 2000)]
[Notices]
[Pages 49989-49990]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-20720]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1435]


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension for an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the reporting requirements 
necessary to meet the substantial evidence standard to demonstrate the 
safety and effectiveness of a new animal drug.

DATES: Submit written or electronic comments on the collection of 
information by October 16, 2000.

ADDRESSES:  Submit electronic comments on the collection of information 
via the Internet at: http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm. Submit written comments on the collection 
of information to the Dockets Management Branch (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
All comments should be identified with the docket number found in 
brackets in the heading of this document.

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: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

Substantial Evidence of Effectiveness of New Animal Drugs--21 CFR 
Part 514 (OMB Control Number 0910-0356)--Extension

    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 on 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, it will reduce the number of 
adequate and well-controlled studies necessary to demonstrate the 
effectiveness of certain combination new animal drugs, it will 
eliminate the need for an adequate and well-controlled dose titration 
study, and it 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.
    Respondents to this collection of information are persons and 
businesses, including small businesses.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 49990]]



                                 Table 1.--Estimated Annual Reporting Burden \1\
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
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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: August 9, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-20720 Filed 8-15-00; 8:45 am]
BILLING CODE 4160-01-F