69 FR 3 pgs. 666-667 - Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Type: NOTICEVolume: 69Number: 3Pages: 666 - 667
Docket number: [Docket Nos. 2003M-0442, 2003M-0443, 2003M-0444, 2003M-0445, 2003M-0446, and 2003M-0447]
FR document: [FR Doc. 04-132 Filed 1-5-04; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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.
| 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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