[ECOLOG-L] Fellowship--Pharmaceutical Environmental Assessment Research

[Jim Laurenson]

Opportunity: Pharmaceutical Environmental Assessment Research - CDER

Organization: U.S. Food and Drug Administration (FDA)

Program: Center for Drug Evaluation and Research (CDER)

Reference Code: FDA-CDER-2015-0062

Academic Levels:
• Postdoctoral
• Post-Master's

Description:
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 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. The new EA draft guidance, Questions and Answers
Regarding Drugs with Estrogenic, Androgenic, or Thyroid Activity, informs
drug applicants that recent research indicates that some drugs with hormonal
activity in the environment may exhibit “extraordinary circumstances” and
that the Agency may require additional ecotoxicity testing for applications
submitted for drugs with hormonal activity. In addition, antimicrobial,
additivity/synergism, nanotechnology, and other properties have been
implicated for possible adverse environment effects, as well as human
effects through environmental pathways. Also, other Centers (e.g., CVM),
agencies (e.g., EPA), and regions (e.g., EU) have begun addressing these
issues through research, guidance, and regulatory development. The EA Staff
requires support for research and implementation to address these issues.

Project objectives include:
1. Identify appropriate ecological toxicity endpoints, study designs, and
testing approaches to best characterize risks due to the introduction of
drugs with hormonal activity into the environment.
2. Assess the potential environmental role of other properties and effects,
including antimicrobial resistance, nanotechnology, and
additivity/synergism, for drugs normally subject individually to a
categorical exclusion.
3. Evaluate approaches currently established or undergoing research,
guidance development, and regulatory changes by other Centers, agencies, and
countries/regions.
4. Determine how to best incorporate the results within CDER’s current
regulatory structure and in harmony with other Centers, agencies, and
countries/regions.

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 participant will receive a monthly stipend commensurate with
educational level and experience. Proof of health insurance is required for
participation in this program. The appointment is full-time at FDA 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 Master's or Doctoral degree in aquatic ecology, biology, biochemistry,
toxicology, or a closely related field.
• A strong understanding of biochemical or adverse outcome pathways.
• Knowledge or experience with drugs in the environment preferred.
Eligibility Requirements
• Degree: Currently pursuing a Doctoral degree or Master's degree or have
received one of these degrees within 60 months.

Discipline(s):
• Life Health and Medical Sciences
o Biochemistry
o Biology, General
o Cellular and Molecular Biology
o Developmental Biology
o Environmental Health
• Other Physical Sciences
o Environmental Chemistry
• Environmental and Marine Sciences
o Environmental Sciences
• Computer Sciences
o Scientific Computing and Informatics

How To Apply:
See http://orise.orau.gov/fda/applicants/description.aspx?JobId=18495

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Jim Laurenson
Senior Toxicologist/Environmental Officer
Center for Drug Evaluation & Research
U.S. Food & Drug Administration
10903 New Hampshire Ave., Bldg. 21, Rm. 1626
Silver Spring, MD 20993
301-796-4872 (office)
703-342-9496 (cell)
james.l...@fda.hhs.gov