Federal Register/Vol. 77, No. 115/Thursday, June 14, 2012
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Federal Register / Vol. 77, No. 115 / Thursday, June 14, 2012 / Notices 35691 TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JANUARY 1, 2012, THROUGH MARCH 31, 2012—Continued PMA No., Docket No. Applicant Trade name Approval date P060008.S046, FDA–2012–M–0210 ... Boston Scientific Corp ......................... TAXUS Liberte´ Paclitaxel-Eluting Cor- February 22, 2012. onary Stent System (Monorail and Over-The-Wire Delivery Systems). P030025.S086, FDA–2012–M–0209 ... Boston Scientific Corp ......................... TAXUS Express2 Paclitaxel-Eluting February 22, 2012. Coronary Stent System (Monorail and Over-The-Wire Delivery Sys- tems). P110023, FDA–2012–M–0221 ............ ev3, Inc ................................................ Everflex Self-Expanding Peripheral March 7, 2012. Stent System (Everflex). P070004, FDA–2012–M–0250............ Sientra, Inc.......................................... SIENTRA Silicone Gel Breast Im- March 9, 2012. plants. II. Electronic Access LOCATION: The meeting will be held at submissions. In the process of Persons with access to the Internet the FDA White Oak Campus, 10903 considering these changes, FDA has may obtain the documents at http:// New Hampshire Ave., Bldg. 31 previously made available for comment www.fda.gov/MedicalDevices/ Conference Center, Great Room 1503, versions of documents that support ProductsandMedicalProcedures/ Silver Spring, MD 20993. The following making regulatory submissions in DeviceApprovalsandClearances/ link contains public meeting attendee electronic format using the (eCTD) information as well as frequently asked PMAApprovals/default.htm and http:// specifications. These draft documents questions and answers regarding public www.fda.gov/MedicalDevices/ represented FDA’s major updates to meetings at White Oak: http:// ProductsandMedicalProcedures/ Module 1 of the eCTD based on www.fda.gov/AboutFDA/ DeviceApprovalsandClearances/ previous comments. FDA will make WorkingatFDA/BuildingsandFacilities/ HDEApprovals/ucm161827.htm. available revised versions of these WhiteOakCampusInformation/ documents in preparation for this Dated: June 8, 2012. ucm241740.htm. meeting. These documents will be Leslie Kux, CONTACT: Julie Quinonez, Center for posted at: http://www.fda.gov/Drugs/ Assistant Commissioner for Policy. Drug Evaluation and Research, Food DevelopmentApprovalProcess/ [FR Doc. 2012–14486 Filed 6–13–12; 8:45 am] and Drug Administration, 10903 New FormsSubmissionRequirements/ BILLING CODE 4160–01–P Hampshire Ave., Bldg. 22, Rm. 1135, ElectronicSubmissions/ucm253101.htm. Silver Spring, MD 20993, 301–796– If you need special accommodations 0282, FAX: 301–796–9876, email: due to a disability, please contact Julie DEPARTMENT OF HEALTH AND [email protected]. Quinonez (see Contact) at least 7 days HUMAN SERVICES Registration: Send registration in advance. information (including name, title, firm Dated: June 8, 2012. Food and Drug Administration name, address, telephone, and fax Leslie Kux, number) to Julie Quinonez (see [Docket No. FDA–2012–N–0001] Contact). Registrations will be accepted Assistant Commissioner for Policy. in the order that they are received with [FR Doc. 2012–14469 Filed 6–13–12; 8:45 am] Update to Electronic Common BILLING CODE 4160–01–P Technical Document Module 1 a limit of 350. SUPPLEMENTARY INFORMATION: The eCTD AGENCY: Food and Drug Administration, is an International Conference on DEPARTMENT OF HEALTH AND HHS. Harmonization (ICH) standard based on HUMAN SERVICES ACTION: Notice of meeting. specifications developed by ICH and its member parties. The Center for Drug Food and Drug Administration The Food and Drug Administration Evaluation and Research (CDER) and the (FDA) is announcing the following Center for Biologics Evaluation and [Docket No. FDA–2012–N–0517] meeting: Update to Electronic Common Research (CBER) have been receiving Notice of Withdrawal of Certain Technical Document Module 1. The submissions in the eCTD format since topic to be discussed is final Unapproved Abbreviated New Drug 2003, and the eCTD has been the Applications documentation of the Electronic standard for electronic submissions to Common Technical Document (eCTD) CDER and CBER since January 1, 2008. AGENCY: Food and Drug Administration, Module 1, which is used for electronic In fact, the majority of new electronic HHS. submission of administrative and submissions are now received in eCTD ACTION: Notice. prescribing information by industry. format. Since adoption of the eCTD The purpose of the meeting is to provide standard, it has become necessary to SUMMARY: The Food and Drug clarification and answer questions from update the administrative portion of the Administration (FDA or the Agency) is industry and software vendors regarding eCTD Module 1 to reflect regulatory announcing its intention to deem to be the changes being made to this module. changes; to provide clarification of withdrawn any abbreviated new drug Registration is required in advance and business rules for submission, applications (ANDAs) that have been participation will be limited. processing, and review; to refine the determined to be incomplete and as to DATES: Date and Time: The meeting characterization of promotional labeling which the ANDA applicant has not will be held on Tuesday, September 18, and advertising material; and to communicated with FDA since July 8, 2012, from 8 a.m. to 11:30 a.m. facilitate automated processing of 1991. Each of these applications will be VerDate Mar<15>2010 14:34 Jun 13, 2012 Jkt 226001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\14JNN1.SGM 14JNN1 pmangrum on DSK3VPTVN1PROD with NOTICES 35692 Federal Register / Vol. 77, No. 115 / Thursday, June 14, 2012 / Notices deemed to have been withdrawn the applicant informs the Agency in Abraxis Pharmaceutical Products voluntarily by the applicant unless the writing by the date set forth under DATES AH Robins, Co. applicant informs the Agency in writing in this document of its intent to actively Alpharma US Pharmaceuticals Division that it intends to actively pursue pursue approval of the application. Ambix Laboratories Division of approval of the application(s) (see Therefore, in the absence of a written Organics Corp America DATES). notice with respect to an Inactive ANDA Ankerfarm SpA DATES: The applicant of an ANDA by the date specified in this notice, the Ankerman SpA covered by this notice that intends to ANDA will be considered to have been Antibioticos SA actively pursue approval of its withdrawn by the applicant. No further Arcum Pharmaceutical Corp. application must submit a written notice of the withdrawal of Inactive Banner Pharmacaps, Inc. notification to FDA by August 13, 2012. ANDAs will be provided. Withdrawal of Barr Laboratories, Inc. an unapproved application is without Baxter Healthcare Corp. ADDRESSES: Applicants should submit prejudice to resubmission of that Beecham Laboratories Division of written notifications to the ANDA application (21 CFR 314.65). Because of Beecham Inc. archival file to the Office of Generic the length of time that has passed since Beecham SA Drugs, Center for Drug Evaluation and these applications were submitted, FDA Bel Mar Laboratories, Inc. Research, Food and Drug strongly recommends that any applicant Biocraft Laboratories, Inc. Administration, Document Control intending to actively pursue approval Biometric Testing, Inc. Room, MPN7, 7620 Standish Pl., review the application carefully to Boots Laboratories, Inc., Division of Rockville, MD 20855. A copy of written determine whether it satisfies current Boots Pharmaceuticals Inc. notifications should also be submitted ANDA requirements (21 CFR part 314). Bristol Laboratories, Inc., Division of to Thomas Hinchliffe, Center for Drug Bristol Myers Co. Evaluation and Research (HFD–617), III. Action by the Applicant Bristol Myers Co. International Division Food and Drug Administration, 7500 If the applicant wishes to actively Bristol Myers Industrial Division Standish Pl., rm. N–142, MPN2, pursue approval of an Inactive ANDA Bristol Myers Squibb Rockville, MD 20855, FAX: 240–276– and does not wish the application to be Camall Co., Inc. 8440, email: [email protected]. deemed by FDA to have been Carlo Erba SpA FOR FURTHER INFORMATION CONTACT: voluntarily withdrawn, the applicant Century Pharmaceuticals, Inc. Thomas Hinchliffe, Center for Drug must inform the Agency in writing Chemibiotic Ireland, Ltd. Evaluation and Research (HFD–617), within the time specified in this Chromalloy Laboratories Division of Food and Drug Administration, 7500 document. Written notice should be Chromalloy Pharmaceuticals, Inc. Standish Pl., rm. N–142, MPN2, provided to Thomas Hinchliffe and the Clifford Chemical Corp. Rockville, MD 20855, 240–276–8433, Office of Generic Drugs (see ADDRESSES). CM Bundy Co. FAX: 240–276–9310, email: FDA also asks any applicant that Comatic Laboratories, Inc. [email protected]. agrees to consider its application to be Credo Co. SUPPLEMENTARY INFORMATION: voluntarily withdrawn to send a written Delco Chemical Co., Inc. notice to Thomas Hinchliffe and the Dell Laboratories, Inc. I. Background Office of Generic Drugs (see ADDRESSES) Dermasave Laboratories, Inc. FDA has identified 364 ANDAs for to confirm that agreement. However, Dista Products Co. Division of Eli Lilly which FDA has not received any applicants of Inactive ANDAs covered & Co. communication from the ANDA by this notice who wish their DM Pharmaceuticals, Inc. applicant since July 8, 1991, or