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

[Printable PDF (75 KB)]

[Federal Register: March 15, 2007 (Volume 72, Number 50)]
[Notices]
[Page 12179]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15mr07-69]

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