[Printable PDF]
[Federal Register: May 27, 2004 (Volume 69, Number 103)]
[Notices]
[Page 30320]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27my04-70]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003M-0462]
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://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 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 in writing by FDA 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
October 1, 2003, through December 31, 2003. 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 October 1, 2003, through December 31, 2003
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PMA No./Docket Approval
No. Applicant Trade Name Date
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BP 000023/02003M- MedMira MedMira Reveal Rapid Apr. 16,
0462 Laboratories, HIV-1 Antibody Test 2003
Inc.
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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 20, 2004.
Jesse Goodman,
Director, Center for Biologics Evaluation and Research.
[FR Doc. 04-11947 Filed 5-26-04; 8:45 am]
BILLING CODE 4160-01-S