[Printable PDF]
[Federal Register: June 30, 2004 (Volume 69, Number 125)]
[Notices]
[Page 39484-39485]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30jn04-81]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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 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
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PMA No./Docket Approval
No. Applicant Trade Name Date
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BP 030025/02004M- Trinity Trinity Uni-Gold Recombigen December
0203 Biotech HIV, Uni-Gold Recombigen 23, 2003
plc HIV Positive and Negative
Controls
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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: May 17, 2004.
Jesse Goodman,
Director, Center for Biologics Evaluation and Research.
[FR Doc. 04-14805 Filed 6-29-04; 8:45 am]
BILLING CODE 4160-01-S