Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Summaries of Safety and Effectiveness Data for Premarket Approval Applications, 48658 [E7-16706]

Download as PDF 48658 Federal Register / Vol. 72, No. 164 / Friday, August 24, 2007 / Notices Dated: August 20, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–16795 Filed 8–23–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. 2007M–0244 and 2007M–0263] 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. 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: Nathaniel L. Geary, 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 https:// 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 administrative 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 data were placed on the Internet from April 1, 2007, through June 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 APRIL 1, 2007, THROUGH JUNE 30, 2007 PMA No./Docket No. Applicant Trade name BP060002/0/2007M–0244 Abbott Molecular, Inc. Abbott RealTime HIV–1 Amplification Reagent Kit, Abbott RealTime HIV–1 Calibrator Kit, and Abbott RealTime HIV–1 Control Kit May 11, 2007 BP050069/0/2007M–0263 Roche Molecular Systems, Inc. COBAS AmpliPrep/COBAS TaqmanHIV–1 Test, 48 Tests, COBAS Ampliprep/COBAS Taqman Wash Reagent, 5.1.L May 11, 2007 II. Electronic Access DEPARTMENT OF HEALTH AND HUMAN SERVICES Persons with access to the Internet may obtain the documents at https:// www.fda.gov/cber/products.htm. Food and Drug Administration Dated: August 17, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–16706 Filed 8–23–07; 8:45 am] yshivers on PROD1PC66 with NOTICES BILLING CODE 4160–01–S [Docket No. 1999D–1878 (formerly Docket No. 99D–1878)] ‘‘Guidance for Industry: ‘Lookback’ for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV;’’ Availability AGENCY: Food and Drug Administration, HHS. VerDate Aug<31>2005 14:35 Aug 23, 2007 Jkt 211001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 Approval date ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a document entitled ‘‘Guidance for Industry: ‘Lookback’ for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV,’’ dated August 2007. The guidance document provides recommendations for complying with the HCV ‘‘Lookback’’ requirements. This guidance document finalizes the guidance entitled, ‘‘Draft Guidance for Industry: Current Good Manufacturing Practice for Blood and E:\FR\FM\24AUN1.SGM 24AUN1

Agencies

[Federal Register Volume 72, Number 164 (Friday, August 24, 2007)]
[Notices]
[Page 48658]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-16706]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 2007M-0244 and 2007M-0263]


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.

-----------------------------------------------------------------------

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: Nathaniel L. Geary, 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 https://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 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 April 1, 2007, through June 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 April 1, 2007, Through June 30, 2007
------------------------------------------------------------------------
PMA No./Docket                                                 Approval
      No.         Applicant             Trade name               date
------------------------------------------------------------------------
BP060002/0/     Abbott         Abbott RealTime HIV-1         May 11,
 2007M-0244      Molecular,     Amplification Reagent Kit,    2007
                 Inc.           Abbott RealTime HIV-1
                                Calibrator Kit, and Abbott
                                RealTime HIV-1 Control Kit
------------------------------------------------------------------------
BP050069/0/     Roche          COBAS AmpliPrep/COBAS         May 11,
 2007M-0263      Molecular      TaqmanHIV-1 Test, 48 Tests,   2007
                 Systems,       COBAS Ampliprep/COBAS
                 Inc.           Taqman Wash Reagent, 5.1.L
------------------------------------------------------------------------

II. Electronic Access

    Persons with access to the Internet may obtain the documents at 
https://www.fda.gov/cber/products.htm.

    Dated: August 17, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-16706 Filed 8-23-07; 8:45 am]
BILLING CODE 4160-01-S

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