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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Request for Nomination to the FDA International Inspection Cadre

Subject:
Request for Nomination to the FDA International
Area:
Operations Management
Date Revised:
March, 16 2009

 

 
ATTACHMENT A
Guiding Principles for the designation of a person as “medically not qualified” for the purpose of international travel.
 
Background
 
Medical exemptions to conducting inspections should be applied equally to both foreign and domestic inspections.   If a CSO is medically qualified to conduct a domestic inspection, they should typically be considered medically qualified to conduct a foreign inspection. Understanding, however, that due to some uniqueness in foreign travel (e.g. potentially longer plane rides, handling of more luggage and inspection supplies) there may be valid, medical reasons that could result in a temporary or permanent designation of “medically not qualified,” unless there is a reasonable accommodation, processed through the appropriate system (reference the following website for the agency’s Office of Equal Employment Opportunity, http://www.fda.gov/AboutFDA/CentersOffices/OC/OEEODM/default.htm). . To assist in equity and uniformity of the process, the following guiding principles will apply.
 
 
Accommodations-Guiding Principles
 
  1. Medically Not Qualified - Short-term:  Accommodations should be considered for otherwise qualified individuals for short term medical issues (e.g. illness of injury of self or close family member, attending child birth), such as:
a. Postpone foreign trips until later in the fiscal year or otherwise schedule the trips in light of the short term medical issue.
 
b. Reduce overall trip duration and/or location.
 
c. Authorize special travel accommodations (e.g. drive to locations in Canada or Mexico, business class air travel as allowed in existing regulations or agreements)
 
Note: Short-term accommodations should not reduce the annual assignment frequency for the CSOs in this category.
 
2.    Medically Not Qualified - Long-term:  Accommodations should be considered for otherwise qualified individuals for long-term medical issues (e.g. chronic illness or injury) such as:
 
a. Schedule foreign trips with seasonality considerations (e.g. travel in summer could be reasonable)
b. Adjust scheduling processes to identify optimal times that accommodate the traveler’s medically related schedule.
c. Reduce overall trip duration and/or location.
d. Authorize special travel accommodations (e.g. drive to locations in Canada or Mexico, business class air travel as allowed in existing regulations or agreements)
 
Note: Long-term accommodations may affect the typical annual assignment frequency for the CSOs in this category.