Department of Health and Human Services May 20, 2014 – Federal Register Recent Federal Regulation Documents

In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) announces the 2014 annual Vessel Sanitation Program (VSP) public meeting. The annual meeting serves as a forum for HHS/CDC to update interested persons on work completed in 2013 and plans for future activities. HHS/CDC is also opening a public docket so that additional comment and materials may be submitted. The official record of this meeting will remain open for 30 days (through July 10, 2014) so that additional materials or comments may be submitted and made part of the record.

The Food and Drug Administration (FDA) has determined the regulatory review period for INCIVEK 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 Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER), is announcing the availability of the Validation Rules for Standard for Exchange of Nonclinical Data (SEND) Formatted Studies document. CDER is making this document available to improve the standardization and quality of nonclinical data that are submitted to CDER as well as to improve the predictability of data quality and usefulness.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 172 approved new animal drug applications (NADAs) and 14 approved abbreviated new animal drug applications (ANADAs) for oral dosage form new animal drug products from Pfizer, Inc., including its several subsidiaries and divisions, to Zoetis, Inc. FDA is also amending the animal drug regulations to remove entries describing conditions of use for new animal drug products for which no NADA is approved, to make minor corrections, and to reflect a current format. This is being done to increase the accuracy and readability of the regulations.