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Research Project Description

Pharmaceutical Environmental Assessment Research Fellowship
Office of New Drug Quality Assessment
Office of Pharmaceutical Science
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Silver Spring, MD

FDA-CDER-2014-0057

Project Description:

A fellowship opportunity is currently available in the Office of New Drug Quality Assessment within Office of Pharmaceutical Science (OPS) at the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA).

The National Environmental Policy Act of 1969 (NEPA) requires all Federal agencies to assess the environmental impact of their actions. To comply, FDA implements 21 Code of Federal Regulations (CFR) Part 25, which includes a requirement for an environmental assessment (EA) if “extraordinary circumstances” indicate that the specific proposed action may significantly affect the quality of the human environment. Recent research indicates that some drugs with hormonal activity in the environment may exhibit such circumstances, and FDA may need to require additional ecotoxicity testing for applications submitted for drugs with hormonal activity. In addition, antimicrobial, additivity/synergism and other properties have been implicated for possible adverse environmental effects, as well as human effects through environmental pathways.

The selected participant will join EA staff in identifying ecological toxicity endpoints, study designs and testing approaches for drugs with hormonal activity in the environment; assessing other properties, including antimicrobial resistance and additivity/synergism; evaluating approaches by other Centers, agencies and countries/regions; and determining how to best use the results within CDER’s current regulatory structure.

This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The initial appointment is for six months, but may be renewed upon recommendation of FDA contingent on the availability of funds. The participant will receive a monthly stipend commensurate with education level and experience. Proof of health insurance is required for participation in this program. The appointment is full-time at CDER in the Silver Spring, Maryland, area. Participants do not become employees of FDA or the program administrator, and there are no fringe benefits paid.

Qualifications:

  • A Doctoral degree in aquatic ecology, biology, biochemistry, toxicology or a closely related field received within the last five years. 
    • Doctoral-level students currently enrolled at an accredited U.S. college or university in one of the aforementioned fields are also encouraged to apply.
  • Education and/or experience in the following areas is desired:
    • Low-dose chemical-induced (preferably from pharmaceuticals) perturbations of the endocrine systems of aquatic vertebrates;
    • Other adverse endpoints for the aquatic environment, including stressor additivity/synergism and antimicrobial resistance;
    • Technical approaches (e.g., testing assays and strategies) currently established at or undergoing development by other FDA Centers, agencies and countries/regions;
    • Regulatory science framework regarding environmental assessments at CDER and other FDA Centers, agencies and countries/regions.

How to Apply:

To be considered, please send a current CV/resume to the attention of FDArpp@orau.org. Please reference FDA-CDER-2014-0057 in all communications.