[Federal Register Volume 65, Number 94 (Monday, May 15, 2000)]
[Notices]
[Pages 31010-31011]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-12117]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98E-0228]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; Neuro Cybernetic Prosthesis (NCP) System; 
Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending a previous 
determination regarding the regulatory review period for the Neuro 
Cybernetic Prosthesis (NCP) System that appeared in the 
Federal Register of November 10, 1998 (63 FR 63066). FDA is amending 
the notice because the agency agrees with the information provided in a 
request from the applicant for revision of the regulatory review period 
(Request) (Docket No. 98E-022 8/PRC 1, dated and received on January 8, 
1999).

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.

FOR FURTHER INFORMATION CONTACT: Claudia V. Grillo, Regulatory Policy 
Staff (HFD-7), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-594-5645.

SUPPLEMENTARY INFORMATION: In its original application for patent term 
extension, the applicant claimed December 16, 1991, as the date the 
premarket approval application (PMA) for the Neuro Cybernetic 
Prosthesis (NCP) System (PMA 910070) was initially submitted. 
FDA first determined that the PMA was initially submitted on January 
27, 1997, because FDA records indicated that the PMA submitted on 
December 16, 1991, had not been filed, but an amended PMA, renumbered 
as PMA 970003, was the PMA for the approved product.
    The applicant later claimed in its request that FDA's determination 
of the regulatory review period failed to take into account an approved 
amendment to the applicant's originally submitted PMA. Therefore, the 
applicant requested that the agency correct the date the PMA was 
initially submitted to June 1, 1993, the date the approved amendment to 
the PMA was received by FDA.
    FDA reviewed its records and confirmed that the amended PMA, 
received on June 1, 1993, was filed by the agency based on a threshold 
determination that the amended PMA was sufficiently complete to permit 
a substantive review. FDA later determined that additional studies were 
required and issued a major deficiency letter dated September 30, 1994, 
requesting that additional clinical studies be performed. The applicant 
submitted a second amendment to the PMA, which the agency received on 
January 27, 1997. FDA reviewed the amendment and determined that the 
second amendment sufficiently responded to the September 30, 1994, 
deficiency letter, and filed the newly amended PMA on the date of the 
receipt of the completed PMA, January 27, 1997. For administrative 
reasons, the second amendment to the PMA was considered a resubmission 
of the PMA, and it was assigned a new PMA number, P970003, which is the 
PMA number of the approved PMA for the product.
    In the past, FDA has determined that the start of the approval 
phase began with the submission of the first filed PMA for an approved 
product, even if the original filed PMA was later withdrawn and filed 
under a new number. For this reason, FDA now accepts the date of June 
1, 1993, submitted by the applicant in its request, as the date the 
first PMA was filed for the product and the date that the PMA was 
initially submitted.
    Therefore, the applicable regulatory review period for the Neuro 
Cybernetic Prosthesis (NCP) System is 3,237 days. Of this 
time, 1,730 days occurred during the testing phase of the regulatory 
review period, while 1,507 days occurred during the approval phase.
    These periods of time were derived from the following dates, 
summarized from the November 10, 1998, notice and modified by this 
technical amendment:
    1. The date a clinical investigation involving this device was 
begun: September 6, 1988.
    2.The date an application was initially submitted with respect to 
the device under section 515 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360e): June 1, 1993.
    3. The date the application was approved: July 16, 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

[[Page 31011]]

statutory limitations in its calculations of the actual period for 
patent extension. In its application for patent extension, this 
applicant seeks 1,761 days of patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before July 14, 2000, submit to the Dockets 
Management Branch (address above) written comments and ask for a 
redetermination. Furthermore, any interested person may petition FDA, 
on or before November 13, 2000, for a determination on 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: May 6, 2000.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 00-12117 Filed 5-12-00; 8:45 am]
BILLING CODE 4160-01-F