[Federal Register Volume 76, Number 168 (Tuesday, August 30, 2011)]
[Notices]
[Pages 53912-53913]
[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,<PHONE_NUMBER>, e-
mail<EMAIL_ADDRESS>
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,

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


                       Notes from Site Visit to Walmart

Attended by:
Walmart Staff:		Mike Stephenson and others

RILA Staff:		Ben Hobbs, Kelly Cole, Adam Siegel

Others:		staff from Advance Auto and Lowe's

EPA Staff:	Kristin Fitzgerald, Jessica Young, Jamie Piziali, Richard Huggins, Tiffany Kollar, Priscilla Halloran, Dave Nicholas, Jim O'Leary

Date:			January 18, 2012

EPA staff toured a Walmart store and pharmacy in Virginia.

Non-pharmacy:  Walmart uses color-coded bins to segregate their waste streams.  They use a third party information system to aid in their hazardous waste determinations.

Pharmacy:  Walmart uses color-coded bins to segregate their waste streams.  They use a third party for reverse distribution of its pharmaceuticals.  The largest bottle we observed stocked in the pharmacy contained 500 pills.