§ 5.900 - Orphan products.

(a) The Director, Office of Orphan Products Development (OPD), Office of the Senior Associate Commissioner (OSAC), Office of the Commissioner (OC), is authorized to issue notices, and amendments thereto, inviting sponsorship for orphan products (human and animal drugs, biological products, and medical devices) and submission of:

(1) Notices of claimed investigational exemption for a new drug or new drug applications;

(2) Notices of claimed investigational exemption for a new animal drug or new animal drug applications;

(3) Applications for biologics licenses for biological products; or

(4) Applications for an investigational device exemption or premarket approval applications for medical devices, as appropriate.

(b) The Director, OPD, OSAC, OC, is authorized:

(1) To determine whether there is reason to believe that a drug is a drug for a disease or condition that is rare in the United States under section 525(a) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360aa(a)) and to designate such drug as a drug for a rare disease or condition under section 526(a) of the act (21 U.S.C. 360bb(a)).

(2) To issue holders of approved applications or licenses notice and opportunity for the submission of views under section 527(b)(1) of the act (21 U.S.C. 360cc(b)(1)).

(3) To encourage sponsors of an investigational new drug for a rare disease or condition to design protocols for clinical investigations to permit the addition to the investigation of persons with the disease or condition under section 528 of the act (21 U.S.C. 360dd).

(c) The following officials are authorized to provide sponsors, under section 525(a) of the act (21 U.S.C. 360aa(a)), with recommendations for nonclinical or clinical investigations believed to be necessary for a drug for a rare disease or condition to be approved or licensed:

(1) For drugs under their jurisdiction:

(i) The Director, the Deputy Director, and the Directors, Office of Review Management and Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER).

(ii) The Directors and Deputy Directors of the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER.

(iii) The Directors and Deputy Directors of the divisions in the Offices of Drug Evaluation I, II, III, IV, and V, Office of Review Management, CDER.

(2) For biological products under their jurisdiction:

(i) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER).

(ii) The Directors and Deputy Directors, Office of Blood Research and Review (OBRR), Office of Vaccines Research and Review (OVRR), Office of Therapeutics Research and Review (OTRR), CBER.

(iii) The Directors and Deputy Directors of the Divisions in OBRR, OVRR, and OTRR, CBER.

(d) These officials may not further redelegate these authorities.