Department of Health and Human Services November 20, 2009 – Federal Register Recent Federal Regulation Documents

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 and to allow for public comment in response to the notice. This notice solicits comments on requirements for recordkeeping and reports concerning experience with approved new animal drugs, specifically on new data elements to be used in revised versions of Forms FDA 1932 and 1932a. The information contained in the reports required by this regulation enables FDA to monitor the use of new animal drugs after approval and to ensure their continued safety and efficacy.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry 191 entitled ``Changes to Approved NADAsNew NADAs vs. Category II Supplemental NADAs.'' This guidance is intended to assist sponsors who wish to apply for approval of changes to approved new animal drugs that require FDA to reevaluate safety and/or effectiveness data. The goal of this guidance is to create greater consistency in how such applications are handled by sponsors and by FDA's Center for Veterinary Medicine (CVM).

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by First Priority, Inc. The ANADA provides for use of Sulfadimethoxine Soluble Powder in medicated drinking water of cattle, chickens, and turkeys for the treatment of various bacterial infections.

The Indian Health Service (IHS), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre- clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) (44 U.S.C. 3506(c)(2)(A)). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. As required by section 3507(a)(1)(D) of the PRA95, the proposed information collection has been submitted to the Office of Management and Budget (OMB) for review and approval.