SEDASYS Computer-Assisted Personalized Sedation System; Ethicon Endo-Surgery, Incorporated's Petition for Review of the Food and Drug Administration's Denial of Premarket Approval; Notice of Cancellation of Meeting, 75887 [2011-31105]

Download as PDF 75887 Federal Register / Vol. 76, No. 233 / Monday, December 5, 2011 / Notices Application No. Drug NDA 018168 .................................... NDA 019190 .................................... DEMULEN 1/35–21 (ethinyl estradiol; ethynodiol diacetate) Tablet, 0.035 mg; 1 mg. TRIPHASIL–28 (ethinyl estradiol; levonorgestrel) Tablet, 0.03 mg, 0.04 mg, 0.03 mg; 0.05 mg, 0.075 mg, 0.125 mg. NDA 019192 .................................... TRIPHASIL–21 (ethinyl estradiol; levonorgestrel) Tablet, 0.03 mg, 0.04 mg, 0.03 mg; 0.05 mg, 0.075 mg, 0.125 mg. FDA has reviewed its records and, under § 314.161, has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list the drug products listed in this document in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ identifies, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. Approved ANDAs that refer to the NDAs listed in this document are unaffected by the discontinued marketing of the products subject to those NDAs. Additional ANDAs that refer to these products may also be approved by the Agency if they comply with relevant legal and regulatory requirements. If FDA determines that labeling for these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: November 30, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–31146 Filed 12–2–11; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–P–0176] jlentini on DSK4TPTVN1PROD with NOTICES SEDASYS Computer-Assisted Personalized Sedation System; Ethicon Endo-Surgery, Incorporated’s Petition for Review of the Food and Drug Administration’s Denial of Premarket Approval; Notice of Cancellation of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The meeting of the Medical Devices Dispute Resolution Panel scheduled for December 14, 2011, is cancelled. This meeting was announced SUMMARY: VerDate Mar<15>2010 16:52 Dec 02, 2011 Jkt 226001 Applicant in the Federal Register of November 21, 2011 (76 FR 71980). FOR FURTHER INFORMATION CONTACT: Nancy Braier, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, rm. 5454, Silver Spring, MD 20993–0002, (301) 796–5676, FAX: (301) 847–8510, email: nancy.braier@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Background The meeting of the Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee scheduled for December 14, 2011, is cancelled. On December 14, 2011, this advisory committee was slated to discuss the Center for Devices and Radiological Health’s (CDRH’s) denial of a premarket approval application (PMA) for the SEDASYS computer-assisted personalized sedation system (SEDASYS) submitted by Ethicon EndoSurgery Inc. (EES), the sponsor for SEDASYS. This meeting has been cancelled because EES has withdrawn its petition for review of this denial. On February 26, 2010, CDRH issued a letter to EES indicating that PMA P080009 for SEDASYS was not approvable under § 814.44(f) (21 CFR 814.44(f)) because CDRH concluded that the data and information offered in support of the PMA did not provide a reasonable assurance that the device is safe under the conditions of use prescribed, recommended, or suggested in the proposed labeling, as required by section 515(d)(2)(A) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e(d)(2)(A)). On March 25, 2010, EES requested review of the not approvable letter. Submitted in the form of a petition for reconsideration under 21 CFR 10.33 (see 21 CFR 814.44(f)(2)), EES’s petition stated that, in accordance with § 814.44(f), EES considered the not approvable letter to be a denial of approval of PMA P080009 under § 814.45 (21 CFR 814.45). In accordance with section 515(d)(4) of the FD&C Act, EES requested review of this denial under section 515(g)(2) of the FD&C Act. Subsequently, on October 26, 2010, CDRH issued an order denying approval of the SEDASYS PMA (Denial Order), as PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 Do. Wyeth Pharmaceuticals, Inc., P.O. Box 8299, Philadelphia, PA 19101–8299. Do. required by § 814.45(e)(3). On November 5, 2010, in accordance with section 515(g)(2) of the FD&C Act, FDA granted EES’s petition for review of the Denial Order. FDA’s Office of the Commissioner (OC) referred PMA P080009 and the basis for CDRH’s Denial Order to the Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee, an advisory committee of experts established, in part, to receive referrals of petitions for advisory committee review under section 515(g)(2)(B) of the FD&C Act. (See 76 FR 15321, March 21, 2011.) In the Federal Register of November 21, 2011, FDA announced that this advisory committee was scheduled to meet to discuss the clinical and scientific issues raised by CDRH’s Denial Order on December 14, 2011. By letter dated November 28, 2011, EES notified OC that EES ‘‘withdraws its request for administrative review’’ of that order ‘‘through an independent advisory committee under Section 515(g)(2) of the Federal Food, Drug, and Cosmetic Act.’’ Because EES has withdrawn its petition for review of CDRH’s denial of approval of the SEDASYS PMA, OC regards the matter it initiated closed and is, accordingly, canceling the previously mentioned meeting of the Medical Devices Dispute Resolution Panel scheduled for December 14, 2011. Dated: November 30, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–31105 Filed 12–2–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Meeting Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the AIDS Research Advisory Committee, NIAID. E:\FR\FM\05DEN1.SGM 05DEN1

Agencies

[Federal Register Volume 76, Number 233 (Monday, December 5, 2011)]
[Notices]
[Page 75887]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-31105]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-P-0176]


SEDASYS Computer-Assisted Personalized Sedation System; Ethicon 
Endo-Surgery, Incorporated's Petition for Review of the Food and Drug 
Administration's Denial of Premarket Approval; Notice of Cancellation 
of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The meeting of the Medical Devices Dispute Resolution Panel 
scheduled for December 14, 2011, is cancelled. This meeting was 
announced in the Federal Register of November 21, 2011 (76 FR 71980).

FOR FURTHER INFORMATION CONTACT: Nancy Braier, Center for Devices and 
Radiological Health, 10903 New Hampshire Ave., Bldg. 66, rm. 5454, 
Silver Spring, MD 20993-0002, (301) 796-5676, FAX: (301) 847-8510, 
email: nancy.braier@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Background

    The meeting of the Medical Devices Dispute Resolution Panel of the 
Medical Devices Advisory Committee scheduled for December 14, 2011, is 
cancelled. On December 14, 2011, this advisory committee was slated to 
discuss the Center for Devices and Radiological Health's (CDRH's) 
denial of a premarket approval application (PMA) for the SEDASYS 
computer-assisted personalized sedation system (SEDASYS) submitted by 
Ethicon Endo-Surgery Inc. (EES), the sponsor for SEDASYS. This meeting 
has been cancelled because EES has withdrawn its petition for review of 
this denial.
    On February 26, 2010, CDRH issued a letter to EES indicating that 
PMA P080009 for SEDASYS was not approvable under Sec.  814.44(f) (21 
CFR 814.44(f)) because CDRH concluded that the data and information 
offered in support of the PMA did not provide a reasonable assurance 
that the device is safe under the conditions of use prescribed, 
recommended, or suggested in the proposed labeling, as required by 
section 515(d)(2)(A) of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 360e(d)(2)(A)).
    On March 25, 2010, EES requested review of the not approvable 
letter. Submitted in the form of a petition for reconsideration under 
21 CFR 10.33 (see 21 CFR 814.44(f)(2)), EES's petition stated that, in 
accordance with Sec.  814.44(f), EES considered the not approvable 
letter to be a denial of approval of PMA P080009 under Sec.  814.45 (21 
CFR 814.45). In accordance with section 515(d)(4) of the FD&C Act, EES 
requested review of this denial under section 515(g)(2) of the FD&C 
Act. Subsequently, on October 26, 2010, CDRH issued an order denying 
approval of the SEDASYS PMA (Denial Order), as required by Sec.  
814.45(e)(3). On November 5, 2010, in accordance with section 515(g)(2) 
of the FD&C Act, FDA granted EES's petition for review of the Denial 
Order.
    FDA's Office of the Commissioner (OC) referred PMA P080009 and the 
basis for CDRH's Denial Order to the Medical Devices Dispute Resolution 
Panel of the Medical Devices Advisory Committee, an advisory committee 
of experts established, in part, to receive referrals of petitions for 
advisory committee review under section 515(g)(2)(B) of the FD&C Act. 
(See 76 FR 15321, March 21, 2011.) In the Federal Register of November 
21, 2011, FDA announced that this advisory committee was scheduled to 
meet to discuss the clinical and scientific issues raised by CDRH's 
Denial Order on December 14, 2011.
    By letter dated November 28, 2011, EES notified OC that EES 
``withdraws its request for administrative review'' of that order 
``through an independent advisory committee under Section 515(g)(2) of 
the Federal Food, Drug, and Cosmetic Act.'' Because EES has withdrawn 
its petition for review of CDRH's denial of approval of the SEDASYS 
PMA, OC regards the matter it initiated closed and is, accordingly, 
canceling the previously mentioned meeting of the Medical Devices 
Dispute Resolution Panel scheduled for December 14, 2011.

    Dated: November 30, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-31105 Filed 12-2-11; 8:45 am]
BILLING CODE 4160-01-P

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