E6-18432. Agency Information Collection Activities; Proposed Collection; Comment Request; Substantial Evidence of Effectiveness of New Animal Drugs

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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 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 Burden¹

21 CFR Section	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Respondent	Total Hours
514.4(a)	190	4,546	860	632.6	544,036
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.