Department of Health and Human Services October 5, 2010 – 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, 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 FDA's patent term restoration regulations on due diligence petitions for regulatory review period revision. Where a patented product must receive FDA approval before marketing is permitted, the Office of Patents and Trademarks may add a portion of the FDA review time to the term of a patent. Petitioners may request reductions in the regulatory review time if FDA marketing approval was not pursued with ``due diligence.''

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 the reporting requirements for the collection ``Recommended Glossary and Educational Outreach to Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use.''

The Food and Drug Administration (FDA) announces its intention to accept and consider a single source application for a cooperative agreement to the World Organization for Animal Health (OIE). The OIE is the intergovernmental organization responsible for improving animal health worldwide and is recognized by the World Trade Organization (WTO) as a reference for international sanitary rules, with 175 Member Countries and Territories. The purpose of this agreement is to continue outreach that began in fiscal year (FY) 2009 to expand capacity building to support OIE's services and activities that are needed to carry out OIE's Veterinary International Conference on Harmonization (VICH) Global Outreach to disseminate and implement VICH guidelines at the country level.

The Food and Drug Administration (FDA) is announcing its intention to accept and consider a single source application to award a cooperative agreement to the World Health Organization (WHO) Advisory Group on Integrated Surveillance of Antimicrobial Resistance (AGISAR) and in support of the WHO Global Foodborne Infections Network (GFN) and to provide guidance to the WHO on a framework for the development of an international network to promote and enhance collaboration on harmonization and data sharing among countries with Antimicrobial Resistance (AMR) surveillance programs.

The Food and Drug Administration (FDA) is announcing a 2-day public hearing to obtain input on specific issues and challenges associated with the implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The BPCI Act establishes an abbreviated approval pathway for biological products that are demonstrated to be ``highly similar'' (biosimilar) to, or ``interchangeable'' with, an FDA-licensed biological product. The purpose of this public hearing is to create a forum for interested stakeholders to provide input regarding the agency's implementation of the statute. FDA will take the information it obtains from the public hearing into account in its implementation of the BPCI Act.