[Federal Register Volume 69, Number 3 (Tuesday, January 6, 2004)]
[Pages 666-667]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-132]



Food and Drug Administration

[Docket Nos. 2003M-0442, 2003M-0443, 2003M-0444, 2003M-0445, 2003M-
0446, and 2003M-0447]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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 of safety and 
effectiveness summaries of approved PMAs through the Internet and the 
agency's Division of Dockets Management.

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

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


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 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 
    The following is a list of PMAs approved by CBER for which 
summaries of safety and effectiveness were placed on the Internet from 
December 5, 2001, through September 30, 2003. There were

[[Page 667]]

no denial actions during the 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 Safety and Effectiveness Summaries for Approved PMAs
       Made Available October 1, 2001, through September 30, 2003.
  PMA No./Docket
       No.             Applicant          Trade Name      Approval Date
BP 000009/2003M-   Calypte            Calypte HIV-1      January 12,
 0442               Biomedical Corp.   Urine EIA          2001
BP 010009/2003M-   Calypte            Cambridge Biotech  June 21, 2001
 0443               Biomedical Corp.   HIV-1 Urine
                                       Western Blot
BP 010001/2003M-   BioM[eacute]rieux  NucliSens HIV-1    November 19,
 0444               , Inc.             QT                 2001
BP 000028/2003M-   Bayer Corp.        The VERSANT HIV-1  September 11,
 0445                                  RNA 3.0 Assay      2002
BP 010047/2003M-   OraSure            OraQuick Rapid     November 7,
 0446               Technologies,      HIV-1 Antibody     2002
                    Inc.               Test
BP-020066/2003M-   BioM[eacute]rieux  Vironstika HIV-1   June 6, 2003
 0447               , Inc.             Plus O

II. Electronic Access

    Persons with access to the Internet may obtain the documents at 

    Dated: December 29, 2003.
Jesse Goodman,
Director, Center for Biologics and Research.
[FR Doc. 04-132 Filed 1-5-04; 8:45 am]