Department of Health and Human Services December 20, 2010 – Federal Register Recent Federal Regulation Documents

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given of the following meeting of the Negotiated Rulemaking Committee on Designation of Medically Underserved Populations and Health Professional Shortage Areas.

In compliance with the requirement of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on October 15, 2010, and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

The Food and Drug Administration (FDA, the Agency) is soliciting comments from stakeholders on strategies to address the prevalence of animal drug products marketed in the United States without approval or other legal marketing status. FDA is concerned that the safety and effectiveness of these actively-marketed products has not been demonstrated. Therefore, the Agency is requesting comments on approaches for increasing the number of legally-marketed animal drug products, as well as on the use of enforcement discretion for some unapproved animal drug products in certain limited circumstances.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Taro Pharmaceuticals U.S.A., Inc. The ANADA provides for veterinary prescription use of mupirocin ointment for the treatment of bacterial skin infections in dogs.

The Food and Drug Administration (FDA) has determined the regulatory review period for FOLOTYN and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

The Regulatory Flexibility Act of 1980 and Executive Order (EO) 12866 require the semi-annual issuance of an inventory of rulemaking actions under development throughout the Department with a view to offering summarized information about forthcoming regulatory actions for public review.