[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]
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