[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]
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FEDERAL TRADE COMMISSION
[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, 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
