[Federal Register: May 27, 2004 (Volume 69, Number 103)]
[Notices]               
[Page 30317]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27my04-68]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 84N-0102]

 
Cumulative List of Orphan Drug and Biological Designations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the cumulative list of orphan drug and biological 
designations as of December 31, 2003. FDA has announced the 
availability of previous lists, which are updated monthly, identifying 
the drugs and biologicals granted orphan designation under the Federal 
Food, Drug, and Cosmetic Act (the act).

ADDRESSES: Copies of the cumulative list of orphan drug and biological 
designations are available from the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, and the Office of Orphan Products Development (HF-
35), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-827-3666.

FOR FURTHER INFORMATION CONTACT: Jeffrey Fritsch, Office of Orphan 
Products Development (HF-35), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-3666.

SUPPLEMENTARY INFORMATION: FDA's Office of Orphan Products Development 
(OPD) reviews and takes final action on applications submitted by 
sponsors seeking orphan designation of their drug or biological 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 cumulative list of orphan drug and biological 
designations. This list includes the name of the drug or biological, 
the specific disease/condition for which the drug or biological is 
designated, and information about the sponsor such as the name, 
address, telephone, and contact.
    At the end of each calendar year, the agency publishes a cumulative 
list of orphan drug and biological designations current through the 
calendar year. The list that is the subject of this notice is the 
cumulative list of orphan drug and biological designations through 
December 31, 2003, and, therefore, brings the April 15, 2003 (68 FR 
18247) publication up to date. This list is available upon request from 
the Division of Dockets Management (see ADDRESSES). Those requesting a 
copy should specify Docket No. 84N-0102, which is the docket number for 
this document. In addition, the list is updated monthly and is 
available upon request from OPD or FDA's Division of Dockets Management 
(see ADDRESSES). The current list is also available on the Web site, 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/orphan.

    The orphan designation of a drug or biological applies only to the 
sponsor who requested the designation. Each sponsor interested in 
developing a drug or biological for an orphan indication must apply for 
orphan 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 (21 CFR 316.23). Copies of the orphan drug 
regulations (21 CFR part 316) (57 FR 62076, December 29, 1992) and 
explanatory background materials for use in preparing an application 
for orphan designation may be obtained from OPD (see ADDRESSES).
    The names of the drugs and biologicals shown in the cumulative list 
of orphan designations may change upon marketing approval/licensing, 
reflecting the established, proper name approved by FDA. Because drugs 
and biologicals not approved/licensed for marketing are 
investigational, the appropriate established, proper name has not 
necessarily been assigned.

    Dated: May 19, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-11948 Filed 5-26-04; 8:45 am]

BILLING CODE 4160-01-S