Outside employment and other outside activities.

CFR · 2024-01-01 · US · Title 5

(a) (b) (1) (2) (3) (c) (2) (3) (i) Engage in any self-employed business activity for which the sale or promotion of FDA-regulated products is expected to constitute ten percent or more of annual gross sales or revenues; or (ii) Engage in employment, as defined in 5 CFR 2635.603(a), whether or not for compensation, with a significantly regulated organization, as defined in § 5501.101(c)(2), unless the employment meets either of the following exceptions: (A) The employment consists of the practice of medicine, dentistry, veterinary medicine, pharmacy, nursing, or similar practices, provided that the employment does not involve substantial unrelated non-professional duties, such as personnel management, contracting and purchasing responsibilities (other than normal “out-of-stock” requisitioning), and does not involve employment by a medical product manufacturer in the conduct of biomedical research; or (B) The employment primarily involves manual or unskilled labor or utilizes talents, skills, or interests in areas unrelated to the substantive programmatic activities of the FDA, such as clerical work, retail sales, service industry jobs, building trades, maintenance, or similar services. (4) (A) Assert a legal position that is or appears to be in conflict with the interests of the Department of Health and Human Services, the client to which the attorney owes a professional responsibility; or (B) Interpret any statute, regulation or rule administered or issued by the Department.

official document · source cfr-2024 · id 5:§ 5501.106