Document ID: FDA-2008-M-0208-0002
Agency: fda
Document Type: Notice
Title: Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Summaries of Safety and Effectiveness Data for Premarket Approval Applications
Posted Date: 2008-08-07T04:00Z

[Federal Register: August 7, 2008 (Volume 73, Number 153)]
[Notices]               
[Page 46020]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07au08-68]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-M-0208]

 
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 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 
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 data.

FOR FURTHER INFORMATION CONTACT: Tiffany Brown, 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 April 1, 2008, through June 30, 2008. There were no denial actions 
during this 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 April 1, 2008, through June 30, 2008
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  PMA No./Docket
       No.           Applicant      Trade Name         Approval Date
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BP050051/0/FDA-    Ortho-        VITROS                  March 27, 2008
 2008-M-0208        Clinical      Immunodiagnosti
                    Diagnostics   cs Products
                    , Inc.        Anti-HIV 1+2
                                  Calibrator, and
                                  VITROS
                                  Immunodiagnosti
                                  cs Products
                                  Anti-HIV 1+2
                                  Reagent Pack
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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: July 29, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-18125 Filed 8-6-08; 8:45 am]

BILLING CODE 4160-01-S