[Federal Register Volume 68, Number 51 (Monday, March 17, 2003)]
[Notices]
[Pages 12707-12708]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-6226]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98E-0849]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; VITREON; Amendment

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
determination regarding the regulatory review period for purposes of 
patent extension for VITREON that appeared in the Federal Register of 
December 17, 1998 (63 FR 69633). FDA is amending the document because 
the agency agrees with the information provided in a request from the 
applicant for revision of the regulatory review period.

ADDRESSES:  Submit written comments and petitions to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to 
http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Claudia Grillo, Office of Regulatory 
Policy (HFD-013), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-3460.

SUPPLEMENTARY INFORMATION: In its application for patent term 
extension, the applicant claimed November 10, 1989, as the date the 
investigational new drug (IND) application for VITREON (IND 33,858) was 
initially submitted. FDA records showed that IND 33,858

[[Page 12708]]

became effective on November 10, 1989, but upon reviewing the 
application, FDA determined that VITREON should be regulated as a 
device, not a drug, and transferred the application to the Center for 
Devices and Radiological Health (CDRH) on April 13, 1990. The 
application was renumbered as an investigational device exemption (IDE) 
application (IDE G900050). FDA's initial determination of the 
regulatory review period for VITREON used April 13, 1990, as the 
effective date for the investigational application (63 FR 69633, 
December 17, 1998). However, the applicant later claimed in its request 
for a revision of the regulatory review period dated February 16, 1999 
(Docket No. 98E-0489), that FDA's initial determination failed to take 
into account that the original IND became effective on November 10, 
1989, because VITREON was initially considered to be a drug rather than 
a device. The applicant argued that FDA did not object to the November 
10, 1989, submission and that November 10, 1989, should remain valid as 
the effective date of the investigational application because under 
both the IND and IDE regulations, an investigational application 
becomes effective 30 days after submission unless FDA notifies the 
applicant. Therefore, the applicant requested that the agency correct 
the date the investigational application became effective to November 
10, 1989, the effective date of IND 33,858.
    FDA reviewed its records and confirmed that IND 33,858 became 
effective on November 10, 1989. This application was subsequently 
transferred to CDRH because the agency decided to regulate the product 
as a device rather than a drug. Though the transfer of IND 33,858 to 
IDE G900050 occurred for administrative reasons the application was 
sufficiently complete to permit a substantive review. For this reason, 
FDA now accepts the date of November 10, 1989, submitted by the 
applicant in its request, as the date that the investigational 
application for VITREON became effective. Therefore, the applicable 
regulatory review period for the VITREON application is 2,883 days. Of 
this time, 757 days occurred during the testing phase of the regulatory 
review period, while 2,126 days occurred during the approval phase. 
These periods of time were derived from the following dates:
    1. The date a clinical investigation involving this device was 
begun: November 10, 1989. November 10, 1989, is the date that IND 
33,858 became effective. The application was subsequently transferred 
to CDRH because FDA decided to regulate VITREON as a device rather than 
a drug. IND 33,858 was renumbered as IDE G900050 on April 13, 1990. 
This transfer occurred only for administrative reasons because IND 
33,858, later designated IDE G900050, was sufficiently complete to 
permit a substantive review. For this reason, FDA accepts the date of 
November 10, 1989, as the date that a clinical investigation involving 
this device was begun.
    2. The date the application was initially submitted with respect to 
the device under section 515 of the act (21 U.S.C. 360e): December 6, 
1991. FDA has verified the applicant's claim that the premarket 
approval application (PMA) for VITREON (PMA P910068) was initially 
submitted December 6, 1991.
    3. The date the application was approved: September 30, 1997. FDA 
has verified the applicant's claim that PMA P910068 was approved on 
September 30, 1997.
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension. However, the U.S. 
Patent and Trademark Office applies several statutory limitations in 
its calculations of the actual period for patent extension. In its 
application for patent extension, this applicant seeks 1,826 days of 
patent term extension.
    Any interested person may petition FDA, on or before September 15, 
2003, for a determination regarding whether the applicant for extension 
acted with due diligence during the regulatory review period. To meet 
its burden, the petition must contain sufficient facts to merit an FDA 
investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-
42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Comments and petitions should be submitted to the Dockets 
Management Branch. Three copies of any information are to be submitted, 
except that individuals may submit one copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. Comments and petitions may be seen in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: February 3, 2003.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 03-6226 Filed 3-14-03; 8:45 am]
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