[Federal Register Volume 68, Number 182 (Friday, September 19, 2003)]
[Notices]
[Pages 54905-54906]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-23940]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0424]


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 for 
meeting the substantial evidence standards necessary for demonstrating 
the safety and effectiveness of a new animal drug.

DATES: Submit written or electronic comments on the collection of 
information by November 18, 2003.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. Submit written comments on 
the collection of information to the Division of Dockets Management 
(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.

[[Page 54906]]


FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management 
Programs (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 these topics: (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

    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 regulation, Sec.  514.4(a) (21 CFR 514.4(a)), 
to further define substantial evidence in a manner that encourages the 
submission of NADA's and supplemental NADA's and encourages dose range 
labeling. Under the ADAA, substantial evidence is the standard that a 
sponsor must meet to demonstrate the effectiveness of a new animal drug 
for its intended use under the conditions suggested in its proposed 
labeling. Section 514.4(a) gives FDA 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. FDA 
believes this regulation will address the following issues: (1) Reduce 
the number of adequate and well-controlled studies necessary to 
demonstrate the effectiveness of certain combination new animal drugs; 
(2) eliminate the need for an adequate and well-controlled dose 
titration study; and may, in limited instances, (3) 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. Table 1 of this document represents the estimated 
burden of meeting the substantial evidence standard.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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  21 CFR                        Annual Frequency        Total Annual
 Section   No. of Respondents     per Response           Responses        Hours per 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.


    Dated: September 15, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-23940 Filed 9-18-03; 8:45 am]
BILLING CODE 4160-01-S