[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]
BILLING CODE 4160-01-F
