[Federal Register Volume 64, Number 38 (Friday, February 26, 1999)]
[Notices]
[Pages 9515-9516]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-4764]
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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 the cumulative list of orphan drug and biological
designations as of December 31, 1998. FDA has announced the
availability of previous lists, which are updated monthly, identifying
the drugs and biologicals granted orphan designation under the Federal
Food, Drug, and Cosmetic Act (the act).
ADDRESSES: Copies of the cumulative list of orphan drug and biological
designations are available from the Dockets Management Branch (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, 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: Lisa M. Hubbard or Stephanie Donahoe,
Office of Orphan Products Development (HF-35), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3666.
SUPPLEMENTARY INFORMATION: FDA's Office of Orphan Products Development
(OPD) reviews and takes final action on applications submitted by
sponsors seeking orphan designation of their drug or biological 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 cumulative list of orphan drug and biological
designations. This list includes the name of the drug or biological,
the specific disease/condition for which the drug or biological is
designated, and information about the sponsor such as the name,
address, telephone number, and contact.
At the end of each calendar year, the agency publishes a
cumulative list of orphan drug and biological designations current
through the calendar year. The list that is the subject of this notice
is the cumulative list of orphan drug and biological designations
through December 31, 1998, and, therefore, brings the January 30, 1998
(63 FR 4644), publication up to date. This list is available upon
request from the Dockets Management Branch (address above). Those
requesting a copy should specify Docket No. 84N-0102, which is the
docket number for this notice. In addition, the list is updated monthly
and is available upon request from OPD or FDA's Dockets Management
Branch (address above). The current list is also available on the
website, http://www.fda.gov/orphan.
The orphan designation of a drug or biological applies only to the
sponsor who requested the designation. Each sponsor interested in
developing a drug or biological for an orphan indication must apply for
orphan 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
[[Page 9516]]
designation is requested (21 CFR 316.23). Copies of the orphan drug
regulations (21 CFR part 316) (57 FR 62076, December 29, 1992) and
explanatory background materials for use in preparing an application
for orphan designation may be obtained from OPD (address above).
The names of the drugs and biologicals shown in the cumulative
list of orphan designations may change upon marketing approval/
licensing, reflecting the established, proper name approved by FDA.
Because drugs and biologicals not approved/licensed for marketing are
investigational, the appropriate established, proper name has not
necessarily been assigned.
Dated: February 19, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-4764 Filed 2-25-99; 8:45 am]
BILLING CODE 4160-01-F
