[Federal Register: November 18, 2005 (Volume 70, Number 222)]
[Notices]               
[Page 69976-69977]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18no05-62]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005P-0305]

 
Request for Comment on the Status of Pyridoxamine

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of opportunity to comment.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that 
comments related to the status of pyridoxamine may be submitted until 
December 19, 2005. FDA is requesting comments in response to the 
submission of a citizen petition requesting, among other things, that 
the agency determine the status of pyridoxamine. All comments 
postmarked on or before December 19, 2005 will be accepted as part of 
the official record for this matter.

DATES: Submit written comments by December 19, 2005.

ADDRESSES: Submit written comments on the status of pyridoxamine to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.


FOR FURTHER INFORMATION CONTACT: Robert Moore, Center for Food Safety 
and Applied Nutrition (HFS-810), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 301-436-1441.

SUPPLEMENTARY INFORMATION: On July 29, 2005, FDA received a citizen 
petition submitted, under 21 CFR 10.30, by the law firm Morgan Lewis & 
Bockius, LLP, on behalf of BioStratum, Inc. The petition requests that 
the agency: (1) State in writing that dietary supplements that contain 
pyridoxamine are adulterated under the Federal Food, Drug, and Cosmetic 
Act; (2) exercise its enforcement authority under the act to remove 
from interstate commerce dietary supplements containing pyridoxamine; 
and (3) not place this citizen petition in the agency's docket for 
premarket notifications for new dietary ingredients (Docket No. 2004N-
0454).
    In its citizen petition, BioStratum, Inc., states, among other 
things, that it is the manufacturer of Pyridorin (pyridoxamine 
dihydrochloride), which is the subject of an investigational new drug 
application (IND) that was filed with FDA in July 1999 for use as a 
potential therapeutic agent to slow or prevent the progression of 
diabetic nephropathy in patients with type 1 and type 2 diabetes. The 
petition further states that substantial clinical trials have been 
conducted for this drug and that the existence of those studies has 
been made public. In addition, the petition states that pyridoxamine 
was not marketed as a dietary supplement or as a food prior to 
Pyridorin's authorization for investigation as a new drug under an IND.
    FDA has considered the information and legal argument set forth in 
the petition. Based on the facts set forth in the petition, the agency 
tentatively concludes that pyridoxamine, the active moiety\1\ of 
pyridoxamine dihydrochloride, is excluded from the dietary supplement 
definition under the exclusion clause in 21 U.S.C. 321(ff)(3)(B)(ii) 
and therefore may not be marketed as or in a dietary supplement. 
However, although the petition asserts that there is no evidence that 
pyridoxamine was marketed as a dietary ingredient or as a food prior to 
the authorization of Pyridorin for investigation under an IND, the 
agency is interested in receiving information, if any, that bears on 
pyridoxamine's prior marketing as a dietary ingredient or as a food, as 
well as other information that would inform the agency's final decision 
on the status of pyridoxamine.
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    \1\ Under 21 CFR 316.3(b)(2), ``active moiety'' means the 
molecule or ion, excluding those appended portions of the molecule 
that cause the drug to be an ester, salt (including a salt with 
hydrogen or coordination bonds), or other noncovalent derivative 
(such as a complex, chelate, or clathrate) of the molecule, 
responsible for the physiological or pharmacological action of the 
drug substance.

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[[Page 69977]]

    In order to afford all interested parties adequate opportunity to 
participate in this matter, the agency requests comments and supporting 
information related to this matter. Interested persons may submit to 
the Division of Dockets Management (see ADDRESSES) written or 
electronic comments regarding this document. Submit a single copy of 
electronic comments or two paper copies of any mailed comments, except 
that individuals may submit one paper copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the office above 
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between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: November 10, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-22884 Filed 11-17-05; 8:45 am]

BILLING CODE 4160-01-S