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Carl R. Nielsen Bio

Mr. Nielsen is a consultant for a broad range of FDA regulated industries and products. He retired from FDA in February, 2005. A 28-year veteran of the U.S. Food and Drug Administration (FDA), Mr. Nielsen focuses his consultancy on logistics and regulatory requirements for international businesses, including inspections; product sampling and related laboratory processes; FDA and U.S. Customs and Border Protection (Customs) import processes; FDA regulatory and administrative processes; current good manufacturing practices (cGMP's); FDA domestic and import compliance processes; Customs civil and administrative processes; risk management and assessment processes with special knowledge related to importing FDA regulated products; and FDA requirements and processes related to FDA's new bioterrorism rules and initiatives.

Mr. Nielsen's FDA experience was garnered through activities related to positions as a field consumer safety officer (CSO); senior special agent with FDA's Office of Criminal Investigations (OCI); field manager for import operations; compliance officer for the Baltimore field office and FDA's Biologics Core Team; and in his last FDA position as Director of FDA's Office of Regulatory Affairs Division of Import Operations and Policy.

As Director of the Division of Import Operations his duties included directing ORA's import program nationwide, and ensuring Agency policy and procedures that are implemented are in conformance with the Administrative Procedures Act, the FD&C Act and related laws, regulations, agency compliance policies and provisions of international agreements and treaties. He was responsible for developing and implementing compliance procedures and enforcement strategies and activities related to the imported goods in conjunction with Center offices of compliance. These included investigations, detentions, reconditioning, refusals, destruction of refused goods, initiating Customs seizures, liquidated damages and civil money penalties, and referrals for criminal prosecution. Additionally, he supervised the review and comment on all import related compliance programs and assignments with special emphasis on Part V, the regulatory guidance section of the programs. Duties also included the oversight of the development, maintenance, enhancement, and effectiveness of the Agency's electronic import processing system, OASIS, and related systems.

Mr. Nielsen routinely interacted with FDA officials at the highest level to the Commissioner's office on national import policy matters, trade associations, industry, FDA field staff and management, and other high level government officials. He prepared and presented speeches, served on government/industry panel discussions, and actively participated in problem-solving discussions with industry and various agency components.

Besides being a member of the cross-cutting Steering Committee, he was one of the authors, leaders and developers of the concepts in the proposed FDA Commissioner's Import Strategic Plan developed in 2001-2003. The Plan proposed the re-engineering of the Agency's approach and infrastructure to assess and manage risks posed by imported commodities. Many of the same concepts are currently being promoted by the U.S. Department of Health and FDA leaders to improve FDA's import operations.

Mr. Nielsen was actively engaged in the development of guidance documents and procedures required by various provisions of the Public Health Security and Bioterrorism Preparedness and Response Act (BTA) of 2002 which amends the Food, Drug, and Cosmetic Act. These include sections for Import for Export, Marking of refused articles, Prohibition of Port Shopping, and Protection against adulteration of food.

Throughout his career, Mr. Nielsen investigated and managed case work through the regulatory processes of FDA license suspensions and revocations, seizures, injunctions and prosecutions. Highlights include the successful prosecution of an importer of counterfeit active pharmaceutical ingredients while being a field manager and senior special agent with OCI, and developing and managing the Midwest Pharmaceuticals vs. United States case which resulted in precedent case law making OTC ephedrine- containing products misbranded under the Food, Drug, and Cosmetic Act as imitation controlled substances.

Prior to FDA employment, Mr. Nielsen gained experience in research and clinical laboratories. He served as a certified laboratory technologist at the Brooks AFB, Texas Bio-radiological Research and Epidemiological Divisions, and as chief of a clinical microbiological laboratory of a civilian 250 bed hospital, and chief medical technologist of a county hospital laboratory.

Mr. Nielsen received his B.S. in Biology from Dana College, Blair, Nebraska, and continued graduate studies in Human Relations and Business at Abilene Christian University at Dallas, and in behavioral sciences at the University of Texas at San Antonio.

Mr. Nielsen is a member of the Association of Food and Drug Officials and is an active participant with the American Association of Exporters and Importers.