[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR5.58]

[Page 52-53]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 5--DELEGATIONS OF AUTHORITY AND ORGANIZATION--Table of Contents
 
Subpart B--Redelegations of Authority from the Commissioner of Food and 
                                  Drugs
 
Sec. 5.58  Orphan products.

    (a) The Director, Office of Orphan Products Development, Office of 
the Senior Associate Commissioner, Office of the Commissioner, 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, Office of Orphan Products Development, Office of 
the Senior Associate Commissioner, Office of the Commissioner, 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) and 
to designate such drug as a drug for a rare disease or condition under 
section 526(a) of the act.
    (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.
    (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.
    (c) The following officials are authorized to provide sponsors, 
under section 525(a) of the act, 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, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER).
    (ii) The 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

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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 Director, Center for Biologics 
Evaluation and Research (CBER).
    (ii) The Director and Deputy Director, Office of Biological Product 
Review, CBER.
    (iii) The Directors and Deputy Directors of the divisions in the 
Office of Biological Product Review, CBER.

[48 FR 40703, Sept. 9, 1983, as amended at 49 FR 14933, Apr. 16, 1984; 
49 FR 27489, July 5, 1984; 50 FR 19341, May 8, 1985; 54 FR 8318, Feb. 
28, 1989; 55 FR 51688, Dec. 17, 1990; 62 FR 2556, Jan. 17, 1997; 64 FR 
56448, Oct. 20, 1999; 65 FR 34962, June 1, 2000]