§360ee. Grants and contracts for development of drugs for rare diseases and conditions — Inbound Citations

Code of Federal Regulations Citations

Cited by 3 regulations in the Code of Federal Regulations.

• 21 C.F.R. § 101.9(j)(8) — Nutrition labeling of food.

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  (8) Medical foods as defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)). A medical food is a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation. A food is subject to this exemption only if:

  (i) It is a specially formulated and processed product (as opposed to a naturally occurring foodstuff used in its natural state) for the partial or exclusive feeding of a patient by means of oral intake or enteral feeding by tube;

  (ii) It is intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone;

  (iii) It provides nutritional support specifically modified for the management of the unique nutrient needs that result from the specific disease or condition, as determined by medical evaluation;

  (iv) It is intended to be used under medical supervision; and

  (v) It is intended only for a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis for, among other things, instructions on the use of the medical food.

• 21 C.F.R. § 172.345(f) — Folic acid (folacin).

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  (f) Folic acid may be added to a medical food, as defined in section 5(b)(3) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)), at levels not to exceed the amount necessary to meet the distinctive nutritional requirements of the disease or condition for which the food is formulated.

• 7 C.F.R. § 246.2(b)(3) — Definitions.

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  (3) A temporary accommodation of not more than 365 days in the residence of another individual; or

Citations to 21 U.S.C. § 360ee as a whole

• 42 U.S.C. § 236(e)

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  (e) The Board shall submit to the Committee on Labor and Human Resources of the Senate and the Committee on Energy and Commerce of the House of Representatives an annual report—

  (1) identifying the drugs which have been designated under section 526 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360bb] for a rare disease or condition,

  (2) describing the activities of the Board, and

  (3) containing the results of the evaluations carried out by the Board.

  The Director of the National Institutes of Health shall submit to the Board for inclusion in the annual report a report on the rare disease and condition research activities of the Institutes of the National Institutes of Health; the Secretary of the Treasury shall submit to the Board for inclusion in the annual report a report on the use of the credit against tax provided by section 44H² of title 26; and the Secretary of Health and Human Services shall submit to the Board for inclusion in the annual report a report on the program of assistance under section 360ee of title 21 for the development of drugs for rare diseases and conditions. Each annual report shall be submitted by June 1 of each year for the preceding calendar year.

Citations to §360ee(b)

• 21 U.S.C. § 343(q)(5)(A)(iv)

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  (iv) which is a medical food as defined in section 360ee(b) of this title, or

• 21 U.S.C. § 343(r)(5)(A)

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  (A) This paragraph does not apply to infant formulas subject to section 350a(h) of this title and medical foods as defined in section 360ee(b) of this title.

Citations to §360ee(b)(2)

• 42 U.S.C. § 1382a(b)(26)

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  (26) the first $2,000 received during a calendar year by such individual (or such spouse) as compensation for participation in a clinical trial involving research and testing of treatments for a rare disease or condition (as defined in section 360ee(b)(2) of title 21), but only if the clinical trial—

  (A) has been reviewed and approved by an institutional review board that is established—

  (i) to protect the rights and welfare of human subjects participating in scientific research; and

  (ii) in accord with the requirements under part 46 of title 45, Code of Federal Regulations; and

  (B) meets the standards for protection of human subjects as provided under part 46 of title 45, Code of Federal Regulations.

Citations to §360ee(b)(3)

• 21 U.S.C. § 321(ss)(2)

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  (2) a medical food, as defined in section 360ee(b)(3) of this title.