Daily Rules, Proposed Rules, and Notices of the Federal Government
Submit written comments on the information collection requirements by January 6, 2003.
Submit written comments on the collection of information requirements to the Dockets Management Branch (address above). Comments should be identified with the docket number found in brackets in the heading of this document.
The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321
An administrative NADA is an NADA that is submitted after CVM has reviewed all of the technical sections containing the information required for the approval of the new animal drug and CVM has issued a technical section complete letter for each of those technical sections.
The level 1 draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking about the administrative NADA process. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such an approach satisfies the requirements of the applicable statutes and regulations.
Under the Paperwork Reduction Act of 1995 (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
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.
CVM encourages sponsors to submit data and information for review at the most appropriate and productive times in the drug development process rather than submitting all data and information at one time. Sponsors may submit, and CVM intends to review, data or information in support of discrete technical sections during the investigation of the new animal drug. This process is known as phased review. Sponsors may submit part or all of the data and information needed to support a technical section in a phased submission. The data submitted in
After a sponsor has received technical section complete letters for each technical section containing information required for the approval of the new animal drug, the sponsor may file an administrative NADA. The administrative NADA should include a cover letter identifying the submission as an “Administrative NADA,” a signed FDA Form 356V, a table of contents, summary, copies of the technical section complete letters for each required technical section, complete facsimile labeling, and the FOI summary.
The cover letters that should be provided with each submission and with the administrative NADA and the copies of technical section complete letters represent new paperwork.
FDA estimates the burden of this collection of information as follows:
FDA averaged the number of administrative NADA applications and phased submissions for the past 2 years. Hours per response took into account that cover letters submitted summarized information contained in the submission and did not require any new information.
The draft guidance document is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit to the Dockets Management Branch (see
Submit written comments concerning the information collection requirements to the Dockets Management Branch. A copy of the document and received comments may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
Electronic comments may be submitted on the Internet at http://www.fda.gov/dockets/ecomments. Once on the Internet site, select 02D-0449 “The Administrative New Animal Drug Application Process” and follow the directions. A copy of this document may be obtained on the Internet from the CVM home page at http://www.fda.gov/cvm.