• Reviewed and managed the petition process for several indirect and direct food additive petitions that resulted in regulations being issued for their approved uses
• Trained FDA staffers in management procedures and FDA procedures
• Analyzed policy issues presented to the Commissioner Office by the Centers for device, animal drugs/feeds and food and presented reports to the Commissioner laying out options on such policy matters
• Managed the entire food regulatory program for the Office of Regulatory Affairs; interfaced with the Center and the General Counsel to resolve issues as well as with the Department of Health and Human Services and Office of Management and Budget on sensitive regulatory matters (e.g.,sucrose, sodium chloride, caffeine, irradiation, colorants, etc.)
• Co-managed the procedures for which the Food Center was responsible during the cyclamate formal Evidentiary Hearing and was major liaison with the Department’s General Counsel handling the case for FDA
• Supervised a staff that handled the analysis of policy matters, and drafted and/or reviewed correspondence and speeches for the Commissioner

As an independent consultant, Dr. Gund has

• Managed and/or assisted with Expert Panels for various companies’ food ingredients
• Prepared and submitted GRAS petitions and GRN submissions
• Prepared and submitted FAP and FCN
• Conducted literature searches and reviewed the studies on various topics that were part of the above projects
• Prepared various white papers on the global regulatory status of various food ingredients
• Assisted with or drafted 75-day notifications for dietary supplements
• Provided regulatory advice on various labeling and claims related to dietary supplements, food products and cosmetics
• Assisted in the preparation of data for a novel food submission in the UK
• Handled various compliance issues for clients

1991 to Present - Phoenix Regulatory Associates, Ltd., Sterling, VA

As a senior consultant, provides expert consultative advice on regulatory issues regarding foods, including animal feed, human and animal drugs, medical devices, cosmetics, and colors.  She has assisted in or developed various submission documents in the food area, such as GRAS Affirmation petitions and GRAS Notification Submission, Food Additive petition and Food Contact Substances Notifications, Infant Formula Notifications, Feed and Color Additive Petitions and 75-day dietary notifications.  She has also prepared or assisted in the development of 510(k)s, PMAs, INDs, DMFs, and NADAs.  Dr. Gund has also managed scientific expert panels on a variety of GRAS ingredients, and responded to labeling, dietary supplement matters and general regulatory compliance problems.

1987 – 1991 - Hazleton Corporation, Herndon, VA

As a principal consultant, provided principal consulting services for regulatory issues regarding food, including animal feed, animal drugs,cosmetics, and colors.  Managed petition and animal application processes, evaluated and provided advice on labeling and other food administrative procedures of the Food and Drug Administration, and acted as liaison for Hazleton's clients on matters before the Food and Drug Administration.

1976 – 1987 - Food and Drug Administration

The Food and Drug Administration is a scientific, public health oriented regulatory agency responsible for administering the Federal Food, Drug,and Cosmetic Act and related consumer protection statutes.  These laws are intended to assure consumers that foods are safe and wholesome; drugs and devices are safe and effective for their intended uses; all products, including cosmetics, are labeled truthfully and not misleading.  While most products have to be pre-cleared by the agency,it also conducts inspections and post market surveillance programs.

1986 – 1987 - Executive Secretariat, Office of the Commissioner

As the Section Chief, supervised a staff that coordinated correspondence and policy issues with the Center for Food Safety and Applied Nutrition, the Center for Devices and Radiological Health, the Center for Veterinary Medicine, and all of the offices of the Associate Commissioners on behalf of the Commissioner and the Deputy Commissioner.  Supervised the preparation of briefing materials and letters on important issues for the review and/or signature of the Department of Heath and Human Services’ management team.

1981 – 1986 - Division of Regulations Policy, Office of Regulatory Affairs

As the Compliance Officer, had managerial/oversight responsibilities for regulatory issues presented by the Center for Food Safety and Applied Nutrition in the form of Federal Register documents, including food and color additives, GRAS additives, food standards, special dietary foods,compliance policy guides, codex standards, and infant formulas.  Ensured that all documents presented a consistent agency policy for review by the Associate Commissioner of Regulatory Affairs, and represented him in resolving policy disputes.

1980 – 1981 - Office of Policy Coordination, Office of the Commissioner

As a Policy Analyst, analyzed various documents prepared by the Center or other Associate Commissioner’s offices to determine whether all viable alternatives were presented to and discussed for the Commissioner.  Assured that the recommended course of action conformed to the most current agency policy.  Mediated disagreements between the various Centers and the Commissioner’s office during the developmental stages of policy formulation.  Prepared decision documents for the Commissioner’s use in decision making and for his recommendation to the Secretary for a course of action.

1976 – 1980 - Division of Food and Color Additives, Center for Food Safety and Applied Nutrition

As a Consumer Safety Officer, managed the review of food additive petitions by coordinating all data and information relative to the submission and scientific review of both direct and indirect food additive petitions.  Responsible for resolving food additive problems arising from the chemical, toxicological, microbial, or nutritional review of data associated with various food and color additives.  Coordinated matters concerning joint areas of responsibility with other Federal agencies.

Education

• 1974 – 1976 - Neuropharmacology, Post-doctoral position. National Institute of Mental Health, Washington, D. C.
• 1975 - Ph. D., Biochemistry. University of Kansas, Lawrence, Kansas
• 1962 - B. A., Biology/Chemistry. Indiana Central College (Now Indianapolis University) Indianapolis, Indiana

Certification

Regulatory Affairs Certified (R.A.C.), Regulatory Affairs Professionals Society

Honors

• FDA Commendable Service Award, 1986
• FDA Award of Merit, 1985
• Dissertation Fellowship, University of Kansas, 1974
• FAES Fellowship, University of Kansas, 1974
• NDEA Graduate Fellowship, University of Kansas, 1971
• Teaching Fellowship, University of Kansas, 1968 - 1970
• Scholarship, Indiana Central University, 1958 - 1962

Professional Activities

• IFT Member since 1987
• RAPS - Editorial Board Member (1995-1998) and Chairperson 1996
• Member Executive and Professional Women Association
  

Publications

• Engler,R., Bloome, C., Garrison, C. K., and Moore, B., Effect of Physical and Chemical Treatment of the Bouyant Density of Reo Viruses, Arch Fuediegesamte Virusforschung, 32, 329-336 (1970).
• Catalytic and Structural Studies of Formyltetrahydrofolate Synthetase, Thesis, (1974).
• Garrison,C.K., and Himes, R., The Reaction of Diethylpyrocarbonate with Sulhydryl Groups in Carboxylate Buffers, BBRC, 67, 1251-1255 (1975).
• Neff,N.H., Garrison, C.K., Seaborg, J.B., Fuentes, J., Wyatt, R.J., Trace Amines and the Monamine Oxidases, Trace Amines and Brain, Pub.Marcel-Dekker, Psychopharmacology Bulletin, (1975).
• Garrison,C.K., Harmony, J.A.K., Himes, R.H., Renaturation of Formyltetrahydrofolate Synthetase from Urea and Guanidium Chloride Solutions, BBA, 446, 301-399 (1976).
• Garrison-Gund,C.K., and Neff, N.H., Deuterium-Labeled Choline: Lack of Isotope Effects During the Synthesis and Catabolism of Acetylcholine invivo,Neurochemical Res., 1, 679-682 (1976).
• Karoum,F., Garrison-Gund, C.K., Neff, N.H., Wyatt, R.J., Trans-synaptic Modulation of Dopamine Metabolism in the Rat Superior Cervical Ganglion, JPET, 201, 654-661 (1977).
• Neff,N.H., Commissiong, J.W., Calli, C.L., Iuvone, P.M., Garrison-Gund,C.K., and Karoum, F., Mass Spectrometry to Measure Regional Aspects of Dopamine Metabolism, Modern Pharmacology-Toxicology, 10, 781-798; Eds.Usdin, E., Wiener, N., Youndin, M.B.H.; Pub. Marcel-Dekker, (1977).
• Iuvone,P.M., Galli, C.L., Garrison-Gund, C.K., and Neff, N.H., Retinal  Tyrosine Hydroxylase and Dopamine Turnover: Light-Dark Differences Am.Soc. Neurochemistry, (ABS), (1977).
• Neckers,L.M., Trepel, J.B., Garrison-Gund, C.K., and Wyatt, R.J., Cholera ToxinActivation of Serotonin Metabolism in Rat Brain, Am. Soc. of Neurochemistry (ABS), (1977).
• Neff,N.H., Commissiong, J.W., Galli, C.L., Iuvone, P.M., Garrison-Gund,C.K., and Karoum, F., Mass Spectrometry to Measure Regional Aspects of Dopamine Metabolism: Symposium on Biochemistry and Function of Monoamine Enzymes, Steamboat Springs, Colorado, (ABS), (1977).
• Iuvone,P.M., Galli, C.L., Garrison-Gund, C.K., Neff, N.H., Light Activated Tyrosine Hydroxylase and Increased Dopamine Synthesis, Science, 202,901-902 (1978).
• Neckers, L.M.,Neff, N.H., Garrison-Gund, C.K., and Wyatt, R.J., Increased Adenylate Cyclase Activity and Rapid Weight Loss Following Intra-Septal Injection of Cholera Toxin, Eur. Journal of Pharmacology, 51, 141-144 (1978).