[Federal Register Volume 72, Number 164 (Friday, August 24, 2007)]
[Notices]
[Page 48658]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-16706]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2007M-0244 and 2007M-0263]
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: 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://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, 2007, through June 30, 2007. 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, 2007, Through June 30, 2007
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PMA No./Docket Approval
No. Applicant Trade name date
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BP060002/0/ Abbott Abbott RealTime HIV-1 May 11,
2007M-0244 Molecular, Amplification Reagent Kit, 2007
Inc. Abbott RealTime HIV-1
Calibrator Kit, and Abbott
RealTime HIV-1 Control Kit
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BP050069/0/ Roche COBAS AmpliPrep/COBAS May 11,
2007M-0263 Molecular TaqmanHIV-1 Test, 48 Tests, 2007
Systems, COBAS Ampliprep/COBAS
Inc. Taqman Wash Reagent, 5.1.L
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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: August 17, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-16706 Filed 8-23-07; 8:45 am]
BILLING CODE 4160-01-S