Page:United States Statutes at Large Volume 99 Part 1.djvu/410

 99 STAT. 388

PUBLIC LAW 99-91—AUG. 15, 1985

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42 USC 236 note.

Research and development.

Grants. Contracts.

(3) Section 527 of such Act (21 U.S.C. 360cc) is amended— (A) by striking out "or" at the end of paragraph (1) in subsection (a), by redesignating paragraph (2) as paragraph (3), and by inserting after paragraph (1) the following: "(2) issues a certification under section 507, or"; (B) by inserting after "505" in the first sentence of subsection (a) a comma and the following: "issue another certifiA cation under section 507,"; (C) by inserting after "holder of such approved application" in subsection (a) a comma and the following: "of such certification,"; (D) by inserting after "approval of the approved application" in subsection (a) a comma and the following: "the issuance of the certification,"; (E) by striking out "or a license" in subsection (b) and inserting in lieu thereof a comma and the following: "if a certification is issued under section 507 for such a drug, or if a license"; (F) by inserting after "application approval" in subsection (b) a comma and the following: "of the issuance of the certification under section 507,"; (G) by striking out ", if the drug is a biological product," in subsection (b); (H) by inserting after "under section 505" in subsection (b) a comma and the following: "issue another certification under section 507,"; (I) by inserting after "holder of such approved application" in subsection (b) a comma and the following: "of such certification,"; (J) by inserting after "application" in subsection (b)(1) a comma and the following: "of the certification,"; and (K) by inserting after "other applications" in subsection (b)(2) a comma and the following: "issuance of other certifications,".

SEC. 4. NATIONAL COMMISSION ON ORPHAN DISEASES.

(a) ESTABLISHMENT.—There is established the National Commission on Orphan Diseases (hereinafter referred to as the "Commission"). (b) DUTY.—The Commission shall assess the activities of the National Institutes of Health, the Alcohol, Drug Abuse, and Mental Health Administration, the Food and Drug Administration, other public agencies, and private entities in connection with— (1) basic research conducted on rare diseases; (2) the use in research on rare diseases of knowledge developed in other research; (3) applied and clinical research on the prevention, diagnosis, and treatment of rare diseases; and (4) the dissemination to the public, health care professionals, researchers, and drug and medical device manufacturers of knowledge developed in research on rare diseases and other diseases which can be used in the prevention, diagnosis, and treatment of rare diseases. (c) REVIEW REQUIREMENTS.—In assessing the activities of the National Institutes of Health, the Alcohol, Drug Abuse, and Mental Health Administration, and the Food and Drug Administration in connection with research on rare diseases, the Commission shall review— (1) the appropriateness of the priorities currently placed on research on rare diseases; (2) the relative effectiveness of grants and contracts when used to fund research on rare diseases;

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