96 STAT. 2052
PUBLIC LAW 97-414—JAN. 4, 1983 "ORPHAN PRODUCTS BOARD
Establishment. 42 USC 236.
Ante, p. 2049.
I, V
21 USC 355.
42 USC 262.
- \
"SEC. 227. (a) There is established in the Department of Health and Human Services a board for the development of drugs (including biologies) and devices (including diagnostic products) for rare diseases or conditions to be known as the Orphan Products Board. The Board shall be comprised of the Assistant Secretary for Health of the Department of Health and Human Services and representatives, selected by the Secretary, of the Food and Drug Administration, the National Institutes of Health, the Centers for Disease Control, and any other Federal department or agency which the Secretary determines has activities relating to drugs and devices for rare diseases or conditions. The Assistant Secretary for Health shall chair the Board. "(b) The function of the Board shall be to promote the development of drugs and devices for rare diseases or conditions and the coordination among Federal, other public, and private agencies in carrying out their respective functions relating to the development of such articles for such diseases or conditions. "(c) In the case of drugs for rare diseases or conditions the Board shall— "(Devaluate— -• "(A) the effect of subchapter B of the Federal Food, Drug, ii and Cosmetic Act on the development of such drugs, and "(B) the implementation of such subchapter; « "(2) evaluate the activities of the National Institutes of Tii Health and the Alcohol, Drug Abuse, and Mental Health Administration for the development of drugs for such diseases
- ii'. or conditions,
"(3) assure appropriate coordination among the Food and Drug Administration, the National Institutes of Health, the Alcohol, Drug Abuse, and Mental Health Administration, and the Centers for Disease Control in the carrying out of their j respective functions relating to the development of ^rugs for such diseases or conditions to assure that the activities of each agency are complementary, "(4) assure appropriate coordination among all interested Federal agencies, manufacturers, and organizations representing patients, in their activities relating to such drugs, "(5) with the consent of the sponsor of a drug for a rare disease or condition exempt under section 5(y5(i) of the Federal Food, Drug, and Cosmetic Act or regulations issued under such section, inform physicians and the public respecting the availability of such drug for such disease or condition and inform physicians and the public respecting the availability of drugs ,; approved under section 505(c) of such Act or licensed under ' •' section 351 of this Act for rare diseases or conditions, "(6) seek business entities and others to undertake the sponsorship of drugs for rare diseases or conditions, seek investigators to facilitate the development of such drugs, and seek business entities to participate in the distribution of such drugs, and "(7) recognize the efforts of public and private entities and '" individuals in seeking the development of drugs for rare diseases or conditions and in developing such drugs. "(d) The Board shall consult with interested persons respecting the activities of the Board under this section and as part of such
�
