Department of Health and Human Services March 2010 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 18 new animal drug applications (NADAs) and 1 abbreviated new animal drug application (ANADA) from Fort Dodge Animal Health, Division of Wyeth, a wholly owned subsidiary of Pfizer, Inc., to Boehringer Ingelheim Vetmedica, Inc. (Boehringer). In addition, FDA is amending the animal drug regulations to reflect a change of sponsor for 15 NADAs from Fort Dodge Animal Health, Division of Wyeth Holdings Corp., a wholly owned subsidiary of Pfizer, Inc., to Boehringer.

The Administration on Aging (AoA) 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 information collection requirements relating to Area Agency on Aging and Local Service Provider Study.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications,'' dated February 2010. The guidance document provides recommendations to manufacturers of viral vaccines for the characterization and qualification of cell substrates, viral seeds, and other biological materials used for the production of viral vaccines for human use. The guidance announced in this notice finalizes the draft guidance entitled ``Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases,'' dated September 2006, and replaces the information specific to viral vaccines for the prevention and treatment of infectious diseases that the agency provided in the 1993 document entitled ``Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals.''

The Food and Drug Administration (FDA) is denying James A. Holland's request for a hearing and is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) debarring Holland for 5 years from providing services in any capacity to a person who has an approved or pending drug product application. FDA bases this order on a finding that Holland was convicted of a misdemeanor under Federal law for conduct relating to the development or approval of a drug product or otherwise relating to the regulation of a drug product under the act and that the type of conduct underlying the conviction undermines the process for the regulation of drugs. In determining the appropriateness and length of Holland's debarment period, FDA has considered the relevant factors listed in the act. Holland has failed to file with the agency information and analysis sufficient to create a basis for a hearing concerning this action.

The Food and Drug Administration (FDA) is announcing that we have revised the Advisory Committee Information Hotline (the hotline). The hotline provides the public with access to the most current information available on FDA advisory committee meetings. This notice supersedes all previously published announcements of FDA's Advisory Committee Information Hotline.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by ADM Alliance Nutrition, Inc. The supplemental NADA provides for use of a higher concentration chlortetracycline Type A medicated article for the manufacture of medicated feeds for livestock and poultry.