[Federal Register Volume 72, Number 50 (Thursday, March 15, 2007)]
[Notices]
[Page 12179]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-4677]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 2006M-0384, 2006M-0385, 2006M-0386]


Medical Devices Regulated by the Center for Biologics Evaluation 
and Research; Availability of Summaries of Safety and Effectiveness 
Data for Premarket Approval Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing a list of 
premarket approval applications (PMAs) that have been approved by the 
Center for Biologics Evaluation and Research (CBER). This list is 
intended to inform the public of the availability through the Internet 
and the FDA's Division of Dockets Management of summaries of safety and 
effectiveness data of approved PMAs.

ADDRESSES: Submit written requests for copies of summaries of safety 
and effectiveness data to the Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. Please include the appropriate docket number as listed in 
tables 1 and 2 of this document when submitting a written request. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
summaries of safety and effectiveness data.

FOR FURTHER INFORMATION CONTACT: Nathaniel L. Geary, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, suite 200N, 1401 Rockville Pike, Rockville, MD 20852-
1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 30, 1998 (63 FR 4571), FDA 
published a final rule that revised 21 CFR 814.44(d) and 814.45(d)) to 
discontinue individual publication of PMA approvals and denials in the 
Federal Register, providing instead to post this information on the 
Internet at http://www.fda.gov. In addition, the regulations provide 
that FDA publish a quarterly list of available safety and effectiveness 
summaries of PMA approvals and denials that were announced during the 
quarter. FDA believes that this procedure expedites public notification 
of these actions because announcements can be placed on the Internet 
more quickly than they can be published in the Federal Register, and 
FDA believes that the Internet is accessible to more people than the 
Federal Register.
    In accordance with section 515(d)(4) and (e)(2) of the Federal 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(d)(4) and 
(e)(2)), notification of an order approving, denying, or withdrawing 
approval of a PMA will continue to include a notice of opportunity to 
request review of the order under section 515(g) of the act. The 30-day 
period for requesting administrative reconsideration of an FDA action 
under Sec.  10.33(b) (21 CFR 10.33(b)) for notices announcing approval 
of a PMA begins on the day the notice is placed on the Internet. 
Section 10.33(b) provides that FDA may, for good cause, extend this 30-
day period. Reconsideration of a denial or withdrawal of approval of a 
PMA may be sought only by the applicant; in these cases, the 30-day 
period will begin when the applicant is notified by FDA in writing of 
its decision.
    The following is a list of PMAs approved by CBER for which 
summaries of safety and effectiveness data were placed on the Internet 
from March 1, 2006, through June 30, 2006, and from July 1, 2006, 
through September 30, 2006. There were no denial actions during either 
period. The list provides the manufacturer's name, the product's 
generic name or the trade name, and the approval date.

    Table 1.--List of Summaries of Safety and Effectiveness Data for
    Approved PMAs Made Available March 1, 2006, through June 30, 2006
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  PMA No./Docket
       No.             Applicant          Trade Name      Approval Date
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BP050009/0/2006M-  Chembio            SURE CHECK HIV 1/  May 25, 2006
 0384               Diagnostic         2 ASSAY
                    Systems, Inc.
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BP050010/0/2006M-  Chembio            HIV 1/2 STAT-PAKT  May 25, 2006
 0385               Diagnostic         ASSAY
                    Systems, Inc.
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 Table 2.--List Summaries of Safety and Effectiveness Data for Approved
      PMAs Made Available July 1, 2006, through September 30, 2006
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  PMA No./Docket
       No.             Applicant          Trade Name      Approval Date
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BP050030/0/2006M-  Bayer Healthcare   ADVIA Centaur HIV  May 18, 2006
 0386               LLC                1/0/2 Enhanced
                                       Assay
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II. Electronic Access

    Persons with access to the Internet may obtain the documents at 
http://www.fda.gov/cber/products.htm.

    Dated: March 5, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-4677 Filed 3-14-07; 8:45 am]
BILLING CODE 4160-01-S