[Federal Register Volume 72, Number 217 (Friday, November 9, 2007)]
[Notices]
[Pages 63616-63617]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-21986]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007M-0366]
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: Pamela Pope, 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.
[[Page 63617]]
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 July 1, 2007, through September 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 July 1, 2007, through September 30, 2007.
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PMA No./Docket No. Applicant Trade Name Approval Date
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BP060001/0/2007M- ThermoGenesis CryoSeal FS 7/26/2007
0366 Corp. 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: October 31, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-21986 Filed 11-8-07; 8:45 am]
BILLING CODE 4160-01-S