[Federal Register: June 30, 2004 (Volume 69, Number 125)]
[Page 39484-39485]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004M-0203]

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 FDA'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 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.

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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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

[[Page 39485]]

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 were placed on the Internet from 
January 1, 2004, through March 31, 2004. There were 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 January 1, 2004, through March 31, 2004
  PMA No./Docket                                               Approval
       No.          Applicant            Trade Name              Date
BP 030025/02004M-  Trinity      Trinity Uni-Gold Recombigen  December
 0203               Biotech      HIV, Uni-Gold Recombigen     23, 2003
                    plc          HIV Positive and Negative

II. Electronic Access

    Persons with access to the Internet may obtain the documents at 

    Dated: May 17, 2004.
Jesse Goodman,
Director, Center for Biologics Evaluation and Research.
[FR Doc. 04-14805 Filed 6-29-04; 8:45 am]