Notices. Notice
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/register/2004/01/06/04-132·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. 2003M-0442, 2003M-0443, 2003M-0444, 2003M-0445, 2003M-0446, and 2003M-0447] 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. 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://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 § 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 December 5, 2001, through September 30, 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, 2001, through September 30, 2003.** PMA No./Docket No. Applicant Trade Name Approval Date BP 000009/2003M-0442 Calypte Biomedical Corp. Calypte HIV-1 Urine EIA January 12, 2001 BP 010009/2003M-0443 Calypte Biomedical Corp. Cambridge Biotech HIV-1 Urine Western Blot June 21, 2001 BP 010001/2003M-0444 BioMérieux, Inc. NucliSens HIV-1 QT November 19, 2001 BP 000028/2003M-0445 Bayer Corp. The VERSANT HIV-1 RNA 3.0 Assay
(bDNA)September 11, 2002 BP 010047/2003M-0446 OraSure Technologies, Inc. OraQuick Rapid HIV-1 Antibody Test November 7, 2002 BP-020066/2003M-0447 BioMérieux, Inc. Vironstika HIV-1 Plus O Microelisa System June 6, 2003 II. Electronic Access Persons with access to the Internet may obtain the documents at *http://www.fda.gov/cber/products.htm* . Dated: December 29, 2003. Jesse Goodman, Director, Center for Biologics and Research. [FR Doc. 04-132 Filed 1-5-04; 8:45 am]
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