[Federal Register Volume 71, Number 212 (Thursday, November 2, 2006)]
[Notices]
[Pages 64535-64536]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-18432]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0431]


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 of an existing collection of 
information, and to allow 60 days for public comment in response to the

[[Page 64536]]

notice. This notice solicits comments on an information collection to 
meet specified requirements for submitting adequate and well-controlled 
studies to provide substantial evidence of effectiveness for a new 
animal drug.

DATES: Submit written or electronic comments on the collection of 
information by January 2, 2007.

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.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of the Chief 
Information Officer (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 Drug--21 CFR 
514.4(a) (OMB Control Number 0910-0356)--Extension

    Section 512(d)(1)(E) of the Federal Food Drug and Cosmetic Act (the 
act) (21 U.S.C. 360b(d)(1)(E)) requires FDA to issue an order refusing 
to approve a New Animal Drug Application (NADA), if there is a lack of 
substantial evidence that a new animal drug will have the effect it is 
purported or represented to have under the conditions of use prescribed 
in the proposed labeling. Therefore, substantial evidence must be 
submitted to us as part of the NADA to establish effectiveness of a 
drug. Section 514.4(a) specifies requirements for submitting adequate 
and well-controlled studies to provide substantial evidence of 
effectiveness for a new animal drug. This information collection 
requirement provides for submissions of substantial evidence of 
effectiveness information via electronic submissions to the Center for 
Veterinary Medicine.
    We are continuously seeking ways through advances in information 
technology to reduce the burden on the government and sponsors. We are 
continuing to look at what information can be submitted electronically 
and will permit electronic submission of data to NADA files as 
technology and resources permit.
    FDA estimates the burden of this 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          Respondent        Total Hours
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514.4(a)                                                              190                 4,546                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 estimate for the annual reporting burden for this collection of 
information was derived from discussion with industry and agency 
records.

    Dated: October 27, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-18432 Filed 11-1-06; 8:45 am]
BILLING CODE 4160-01-S