Public Database of Products With Orphan-Drug Designations:

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

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.

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,

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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