[Federal Register Volume 60, Number 75 (Wednesday, April 19, 1995)]
[Notices]
[Pages 19597-19598]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-9700]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[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 a cumulative list of designated orphan drugs and 
biologics as of December 31, 1994. FDA has announced the availability 
of previous lists, which are brought up to date monthly, identifying 
the drugs and biologics 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 L. 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 
(OPD) 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 biologics. This list is made current on a monthly basis and 
is available upon request from OPD (contact identified above). At the 
end of each calendar year, the agency publishes an up-to-date 
cumulative list of designated orphan drugs and biologics, 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 FDA's 
Dockets Management Branch (address above). Those requesting a copy 
should specify Docket No. 84N-0102, which is the docket number for this 
notice.
    The list that is the subject of this notice consists of designated 
orphan drugs and biologics through December 31, 1994, and, therefore, 
brings the May 9, 1994 (59 FR 23888) publication up to date.
    The orphan-drug designation of a drug or biologic applies only to 
the sponsor who requested the designation. Each sponsor interested in 
developing an orphan drug or biologic 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 OPD 
(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 proper name.

    Dated: April 13, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-9700 Filed 4-18-95; 8:45 am]
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