[Federal Register Volume 59, Number 88 (Monday, May 9, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-11070]


[[Page Unknown]]

[Federal Register: May 9, 1994]


-----------------------------------------------------------------------

FEDERAL TRADE COMMISSION
[Docket No. 84N-0102]

 

Cumulative List of Orphan-Drug and Biological Designations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a cumulative list of designated orphan drugs and 
biologics as of December 31, 1993. FDA has announced the availability 
of previous lists, which are brought up-to-date monthly, identifying 
the drugs and biologicals granted orphan-drug designation pursuant to 
the Federal Food, Drug, and Cosmetic Act (the act).

ADDRESSES: Copies of the list of current orphan-drug designations and 
of any future lists are or will be available from the Dockets 
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857, and the Office of Orphan 
Products Development (HF-35), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-443-4718.

FOR FURTHER INFORMATION CONTACT: Peter Vaccari, Office of Orphan 
Products Development (HF-35), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-443-4718.

SUPPLEMENTARY INFORMATION: FDA's Office of Orphan Products Development 
reviews and acts on applications submitted by sponsors seeking orphan-
drug designation under section 526 of the act (21 U.S.C. 360bb). In 
accordance with this section of the act, which requires public 
notification of designations, FDA maintains a list of designated orphan 
drugs and biologicals. This list is made current on a monthly basis and 
is available upon request from the Office of Orphan Products 
Development (contact identified above). At the end of each calendar 
year, the agency publishes an up-to-date cumulative list of designated 
orphan drugs and biologicals, including the names of designated 
compounds, the specific disease or condition for which the compounds 
are designated, and the sponsors' names and addresses. The cumulative 
list of compounds receiving orphan-drug designation through 1988 was 
published in the Federal Register of April 21, 1989 (54 FR 16294). This 
list is available on request from the Dockets Management Branch 
(address above). Those requesting a copy should specify the docket 
number found in brackets in the heading of this document.
     The list that is the subject of this notice consists of designated 
orphan drugs and biologicals through December 31, 1993, and, therefore, 
brings the March 2, 1993 (58 FR 12041) publication up to date.
     The orphan-drug designation of a drug or biological applies only 
to the sponsor who requested the designation. Each sponsor interested 
in developing an orphan drug or biological must apply for orphan-drug 
designation in order to obtain exclusive marketing rights. Any request 
for designation must be received by FDA before the submission of a 
marketing application for the proposed indication for which designation 
is requested. (See 53 FR 47577, November 23, 1988.) Copies of the 
regulations (see 57 FR 62076, December 29, 1992) for use in preparing 
an application for orphan-drug designation may be obtained from the 
Office of Orphan Products Development (address above).
     The names used in the cumulative list for the drug and biological 
products that have not been approved or licensed for marketing may not 
be the established or proper names approved by FDA for those products 
if they are eventually approved or licensed for marketing. Because 
these products are investigational, some may not have been reviewed for 
purposes of assigning the most appropriate established or proper name.

    Dated: May 3, 1994.
 Michael R. Taylor,
 Deputy Commissioner for Policy.
[FR Doc. 94-11070 Filed 5-6-94; 8:45 am]
BILLING CODE 4160-01-F