[Federal Register Volume 63, Number 20 (Friday, January 30, 1998)]
[Notices]
[Page 4644]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-2265]


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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 a cumulative list of designated orphan drugs and 
biologics as of December 31, 1997. FDA has announced the availability 
of previous lists, which are brought up-to-date monthly, identifying 
the drugs and biologicals granted orphan-drug designation under 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, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857, 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: Erica K. McNeilly, Office of Orphan 
Products Development (HF-35), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-0983.

SUPPLEMENTARY INFORMATION: FDA's Office of Orphan Products Development 
(OPD) reviews and takes final action 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 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 
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 FDA's Dockets Management Branch (address 
above). Those requesting a copy should specify the docket number found 
in brackets in the heading of this notice.
    The list that is the subject of this notice consists of designated 
orphan drugs and biologicals through December 31, 1997, and, therefore, 
brings the March 13, 1997 (62 FR 11900) 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 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 these 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: January 21, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-2265 Filed 1-29-98; 8:45 am]
BILLING CODE 4160-01-F