Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 30950-30951 [E8-12012]

Download as PDF jlentini on PROD1PC65 with NOTICES 30950 Federal Register / Vol. 73, No. 104 / Thursday, May 29, 2008 / Notices and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA’s determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for marketing the human biologic product LUCENTIS (ranibizumab). LUCENTIS is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration. Subsequent to this approval, the Patent and Trademark Office received patent term restoration applications for LUCENTIS (U.S. Patent Nos. 6,407,213; 6,884,879; and 7,060,269) from Genentech, Inc., and the Patent and Trademark Office requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In letters dated July 24, 2007, and November 21, 2007, FDA advised the Patent and Trademark Office that this human biological product had undergone a regulatory review period and that the approval of LUCENTIS represented the first permitted commercial marketing or use of the product. Shortly thereafter, the Patent and Trademark Office requested that FDA determine the product’s regulatory review period. FDA has determined that the applicable regulatory review period for LUCENTIS is 2,430 days. Of this time, 2,247 days occurred during the testing phase of the regulatory review period, while 183 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: November 6, 1999. The applicant claims October 7, 1999, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was November 6, 1999, which was 30 days after FDA receipt of the IND. 2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 VerDate Aug<31>2005 17:45 May 28, 2008 Jkt 214001 U.S.C. 262): December 30, 2005. The applicant claims December 29, 2005, as the date the biologics license application (BLA) for LUCENTIS (BLA 125156/0) was initially submitted. However, FDA records indicate that BLA 125156/0 was submitted on December 30, 2005. 3. The date the application was approved: June 30, 2006. FDA has verified the applicant’s claim that BLA 125156/0 was approved on June 30, 2006. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension for U.S. Patent Nos. 6,407,213; 6,884,879; and 7,060,269, this applicant seeks 378 days; 307 days or 17 days, respectively, of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments and ask for a redetermination by July 28, 2008. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by November 25, 2008. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at http://www.regulations.gov. PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 Dated: May 8, 2008. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E8–12007 Filed 5–28–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–M–0467] (formerly Docket No. 2007M–0408), [Docket No. FDA– 2007–M–0481] (formerly Docket No. 2007M– 0467), [Docket No. FDA–2007–M–0480] (formerly Docket No. 2007M–0409), [Docket No. FDA–2007–M–0472] (formerly Docket No. 2007M–0413), [Docket No. FDA–2007– M–0468] (formerly Docket No. 2007M–0446), [Docket No. FDA–2007–M–0494] (formerly Docket No. 2007M–0380), [Docket No. FDA– 2007–M–0493] (formerly Docket No. 2007M– 0411), [Docket No. FDA–2007–M–0492] (formerly Docket No. 2007M–0410), [Docket No. FDA–2007–M–0490] (formerly Docket No. 2007M–0415), [Docket No. FDA–2007– M–0491] (formerly Docket No. 2007M–0447] Medical Devices; 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. 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. 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 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. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Samie Allen, Center for Devices and Radiological Health (HFZ–402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240–276–4013. SUPPLEMENTARY INFORMATION: E:\FR\FM\29MYN1.SGM 29MYN1 30951 Federal Register / Vol. 73, No. 104 / Thursday, May 29, 2008 / Notices 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. Instead, the agency now posts this information on the Internet on FDA’s home page at http://www.fda.gov. 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 regulations provide that FDA publish a quarterly list of available safety and effectiveness summaries of PMA approvals and denials that were announced during that quarter. The following is a list of approved PMAs for which summaries of safety and effectiveness were placed on the Internet from October 1, 2007, through December 31, 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 SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM OCTOBER 1, 2007, THROUGH DECEMBER 31, 2007. PMA No./Docket No. Applicant TRADE NAME Approval Date P000009 (S4)/2007M– 0408 Biotronik, Inc. TACHOS DR ATRIAL TX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ICD SYSTEM September 9, 2002 P060031/2007M–0467 Bio-Rad Laboratories BIO–RAD MONOLISA ANTI–HBC EIA April 27, 2007 P060005/2007M–0409 Siemens Medical Solutions Diagnostics IMMULITE/IMMULITE 1000 & IMMULITE 2000 FREE PSA ASSAYS May 11, 2007 P060017/2007M–0413 Veridex, LLC GENESEARCH BREAST LYMPH NODE (BLN) ASSAY July 16, 2007 P040040/2007M–0446 AGA Medical Corp. AMPLATZER MUSCULAR VSD September 7, 2007 P070009/2007M–0380 Obtech Medical GMBH REALIZE ADJUSTABLE GASTRIC BAND MODEL 2200–X September 28, 2007 P070012/2007M–0411 Medtronic Vascular EXPONENT SELF-EXPANDING CAROTIC STENT SYSTEM WITH OVER THE WIRE OR RAPID EXHANGE DELIVERY SYSTEM October 23, 2007 P060038/2007M–0410 Carbomedics, Inc. MITROFLOW AORTIC PERICARDIAL HEART VALVE October 23, 2007 H990002/2007M–0415 Genzyme Biosurgery EPICEL (CULTURED EPIDERMAL AUTOGRAFTS) October 25, 2007 P060035/2007M–0447 Abbott Laboratories ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLS November 6, 2007 II. Electronic Access DEPARTMENT OF HEALTH AND HUMAN SERVICES Persons with access to the Internet may obtain the documents at http:// www.fda.gov/cdrh/pmapage.html. National Institutes of Health Dated: May 16, 2008. Daniel G. Schultz, Director, Center for Devices and Radiological Health. [FR Doc. E8–12012 Filed 5–28–08; 8:45 am] jlentini on PROD1PC65 with NOTICES BILLING CODE 4160–01–S VerDate Aug<31>2005 17:45 May 28, 2008 Proposed Collection; Comment Request; The Prevalence and Incidence of HIV Molecular Variants and Their Correlation With Risk Behaviors and HIV Treatment in Brazilian Blood Donors SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH), will publish periodic summaries of proposed Jkt 214001 PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 projects to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: The Prevalence and Incidence of HIV Molecular Variants and Their Correlation With Risk Behaviors and HIV Treatment in Brazilian Blood Donors. Type of Information Collection Request: NEW. Need and Use of Information Collection: Establishing and monitoring viral prevalence and incidence rates, and identifying risk behaviors for HIV incidence among blood donors, are critical to assessing and reducing risk of HIV transmission through blood transfusion. Identifying donation samples from donors with recent HIV infection is particularly critical as it enables characterization of E:\FR\FM\29MYN1.SGM 29MYN1

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[Federal Register Volume 73, Number 104 (Thursday, May 29, 2008)]
[Notices]
[Pages 30950-30951]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-12012]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-M-0467] (formerly Docket No. 2007M-0408), [Docket 
No. FDA-2007-M-0481] (formerly Docket No. 2007M-0467), [Docket No. FDA-
2007-M-0480] (formerly Docket No. 2007M-0409), [Docket No. FDA-2007-M-
0472] (formerly Docket No. 2007M-0413), [Docket No. FDA-2007-M-0468] 
(formerly Docket No. 2007M-0446), [Docket No. FDA-2007-M-0494] 
(formerly Docket No. 2007M-0380), [Docket No. FDA-2007-M-0493] 
(formerly Docket No. 2007M-0411), [Docket No. FDA-2007-M-0492] 
(formerly Docket No. 2007M-0410), [Docket No. FDA-2007-M-0490] 
(formerly Docket No. 2007M-0415), [Docket No. FDA-2007-M-0491] 
(formerly Docket No. 2007M-0447]


Medical Devices; 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. 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 data 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:  Samie Allen, Center for Devices and 
Radiological Health (HFZ-402), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 240-276-4013.

SUPPLEMENTARY INFORMATION:

[[Page 30951]]

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. Instead, the agency now posts this information on the 
Internet on FDA's home page at http://www.fda.gov. 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 by FDA in writing of its 
decision.
    The regulations provide that FDA publish a quarterly list of 
available safety and effectiveness summaries of PMA approvals and 
denials that were announced during that quarter. The following is a 
list of approved PMAs for which summaries of safety and effectiveness 
were placed on the Internet from October 1, 2007, through December 31, 
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 Safety and Effectiveness Summaries for Approved PMAs
     Made Available From October 1, 2007, through December 31, 2007.
------------------------------------------------------------------------
PMA No./Docket                                                 Approval
      No.          Applicant             TRADE NAME              Date
------------------------------------------------------------------------
P000009 (S4)/   Biotronik,      TACHOS DR ATRIAL TX          September
 2007M-0408      Inc.            IMPLANTABLE CARDIOVERTER     9, 2002
                                 DEFIBRILLATOR ICD SYSTEM
------------------------------------------------------------------------
P060031/2007M-  Bio-Rad         BIO-RAD MONOLISA ANTI-HBC    April 27,
 0467            Laboratories    EIA                          2007
------------------------------------------------------------------------
P060005/2007M-  Siemens         IMMULITE/IMMULITE 1000 &     May 11,
 0409            Medical         IMMULITE 2000 FREE PSA       2007
                 Solutions       ASSAYS
                 Diagnostics
------------------------------------------------------------------------
P060017/2007M-  Veridex, LLC    GENESEARCH BREAST LYMPH      July 16,
 0413                            NODE (BLN) ASSAY             2007
------------------------------------------------------------------------
P040040/2007M-  AGA Medical     AMPLATZER MUSCULAR VSD       September
 0446            Corp.                                        7, 2007
------------------------------------------------------------------------
P070009/2007M-  Obtech Medical  REALIZE ADJUSTABLE GASTRIC   September
 0380            GMBH            BAND MODEL 2200-X            28, 2007
------------------------------------------------------------------------
P070012/2007M-  Medtronic       EXPONENT SELF-EXPANDING      October 23,
 0411            Vascular        CAROTIC STENT SYSTEM WITH    2007
                                 OVER THE WIRE OR RAPID
                                 EXHANGE DELIVERY SYSTEM
------------------------------------------------------------------------
P060038/2007M-  Carbomedics,    MITROFLOW AORTIC             October 23,
 0410            Inc.            PERICARDIAL HEART VALVE      2007
------------------------------------------------------------------------
H990002/2007M-  Genzyme         EPICEL (CULTURED EPIDERMAL   October 25,
 0415            Biosurgery      AUTOGRAFTS)                  2007
------------------------------------------------------------------------
P060035/2007M-  Abbott          ARCHITECT CORE-M REAGENT     November 6,
 0447            Laboratories    KIT/CALIBRATORS/CONTROLS     2007
------------------------------------------------------------------------

II. Electronic Access

    Persons with access to the Internet may obtain the documents at 
http://www.fda.gov/cdrh/pmapage.html.

    Dated: May 16, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E8-12012 Filed 5-28-08; 8:45 am]
BILLING CODE 4160-01-S