
[Federal Register Volume 76, Number 168 (Tuesday, August 30, 2011)]
[Notices]
[Pages 53912-53913]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-22144]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0607]


FDA's Public Database of Products With Orphan-Drug Designation: 
Replacing Non-Informative Code Names With Descriptive Identifiers

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA), Office of Orphan 
Products Development, is announcing that it has replaced non-
informative code names with descriptive identifiers on its public 
database of products that have received orphan-drug designation. The 
Orphan Drug Act mandates that FDA provide notice to the public 
respecting the designation of a drug as an orphan-drug. FDA typically 
provides public notice by publishing a drug's generic or trade name 
upon orphan designation. Where a designated drug does not have a 
generic or trade name, publishing a non-informative code name does not 
meet the statutory disclosure requirement because the public would not 
be able to identify the drug that has received orphan designation.

FOR FURTHER INFORMATION CONTACT: Jeffrey Fritsch, Office of Orphan 
Products Development, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 32, rm. 5276, Silver Spring, MD 20993, 301-796-8660, e-
mail: OPDAR@FDA.HHS.GOV.

SUPPLEMENTARY INFORMATION: FDA publishes the generic name and/or trade 
name of a drug on its Web site at http://www.fda.gov/orphan after it 
designates a drug as an orphan drug. It has come to our attention that 
a small subset of drugs that have received orphan designation were 
published on our public database with non-informative code names. After 
careful consideration of this matter, we have concluded that the Orphan 
Drug Act mandates that FDA identify to the public products that have 
received orphan-drug designation. If a drug has no generic or trade 
name, publishing a non-informative code name for that drug does not 
meet the statutory notice requirement because the public would not be 
able to identify the drug that has received orphan designation.
    In addition to issuing this notice, FDA has mailed letters to 
affected sponsors at their last known address and has posted 
notification on its Web site at http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/HowtoapplyforOrphanProductDesignation/ucm267378.htm. We informed 
sponsors that, on our Web site, we have replaced all non-informative 
code names with descriptive identifiers. We asked that these sponsors 
notify us within 20 days of the date of the letter if they believe that 
their product's current identifier did not accurately identify their 
product to the public.
    Despite reasonable efforts, we were unable to notify a small 
proportion of affected sponsors. It appears that some sponsors may have 
gone out of business or may have transferred ownership of, or 
beneficial interest in, orphan-drug designation without informing FDA. 
(We remind sponsors of their obligations to notify us of any change in 
ownership of orphan-drug designation, under 21 CFR 316.27, and to 
submit brief progress reports to us on an annual basis, under 21 CFR 
316.30.)
    Through this document, FDA seeks to inform sponsors whom the Agency 
has not otherwise been able to notify that, under the Orphan Drug Act's 
notice requirements, all non-informative codes in our public orphan 
drug designations database have been replaced with corresponding 
informative identifiers.
    If you believe this notice applies to you, please visit our Web 
site at http://www.fda.gov/orphan. Under ``Resources for You,'' click 
on the ``Search for Orphan Drug Designations and Approvals'' and enter 
your product. If you believe that your product's current identifier 
does not accurately identify your product to the public,

[[Page 53913]]

please promptly contact Jeffrey Fritsch (see FOR FURTHER INFORMATION 
CONTACT).

    Dated: August 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-22144 Filed 8-29-11; 8:45 am]
BILLING CODE 4160-01-P


