[Federal Register Volume 69, Number 3 (Tuesday, January 6, 2004)]
[Notices]
[Pages 666-667]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-132]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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 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.
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 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
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.
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PMA No./Docket
No. Applicant Trade Name Approval Date
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BP 000009/2003M- Calypte Calypte HIV-1 January 12,
0442 Biomedical Corp. Urine EIA 2001
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BP 010009/2003M- Calypte Cambridge Biotech June 21, 2001
0443 Biomedical Corp. HIV-1 Urine
Western Blot
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BP 010001/2003M- BioM[eacute]rieux NucliSens HIV-1 November 19,
0444 , Inc. QT 2001
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BP 000028/2003M- Bayer Corp. The VERSANT HIV-1 September 11,
0445 RNA 3.0 Assay 2002
(bDNA)
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BP 010047/2003M- OraSure OraQuick Rapid November 7,
0446 Technologies, HIV-1 Antibody 2002
Inc. Test
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BP-020066/2003M- BioM[eacute]rieux Vironstika HIV-1 June 6, 2003
0447 , Inc. Plus O
Microelisa
System
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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: December 29, 2003.
Jesse Goodman,
Director, Center for Biologics and Research.
[FR Doc. 04-132 Filed 1-5-04; 8:45 am]
BILLING CODE 4160-01-S