Transmissible Spongiform Encephalopathies Advisory Committee; Notice of Meeting, 11207-11208 [2013-03577]

Download as PDF Federal Register / Vol. 78, No. 32 / Friday, February 15, 2013 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–D–0395] Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation.’’ This guidance provides FDA’s recommendations on clinical trial designs for surgical ablation devices intended for the treatment of atrial fibrillation. SUMMARY: Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the guidance document entitled ‘‘Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation’’ to the Division of Small Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301–847– 8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Libet Garber, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1254, Silver Spring, MD 20993–0002, 301–796–6912. SUPPLEMENTARY INFORMATION: mstockstill on DSK4VPTVN1PROD with NOTICES DATES: I. Background Atrial fibrillation (AF) is a complex arrhythmia of the heart. This guidance VerDate Mar<15>2010 19:09 Feb 14, 2013 Jkt 229001 describes elements of suggested clinical study design for surgical ablation devices used to treat patients with longstanding persistent AF and patients with symptomatic paroxysmal AF, such as inclusion and exclusion criteria and assessment of effectiveness, which may differ for these patient populations. In the Federal Register of September 14, 2009 (74 FR 46996), FDA announced the availability of the draft guidance document. Interested persons were invited to comment by December 14, 2009. Three sets of comments were received with recommendations related to definitions and certain elements of the recommended study design(s), such as study endpoints, endpoint assessments, appropriate control groups, and followup of study subjects. In response, FDA revised the guidance document to address the comments and clarify our recommendations as appropriate. This guidance supersedes the draft guidance entitled ‘‘Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation,’’ dated September 14, 2009. II. Significance of Guidance This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency’s current thinking on clinical study designs for surgical ablation devices for treatment of atrial fibrillation. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by using the Internet. A search capability for all CDRH guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov. To receive ‘‘Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation,’’ you may either send an email request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 301–847–8149 to receive a hard copy. Please use the document number 1708 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 11207 collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR part 812 have been approved under OMB control number 0910–0078; the collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910–0120; the collections of information in 21 CFR parts 50 and 56 have been approved under OMB control number 0910–0130; and the collections of information under 21 CFR part 814 have been approved under OMB control number 0910–0231. V. Comments Interested persons may submit either written comments regarding this document to the Division of Dockets Management (see ADDRESSES) or electronic comments to https:// www.regulations.gov. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. Dated: February 11, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–03487 Filed 2–14–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Transmissible Spongiform Encephalopathies Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Transmissible Spongiform Encephalopathies Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on March 14, 2013, from 8 a.m. to 4 p.m. E:\FR\FM\15FEN1.SGM 15FEN1 mstockstill on DSK4VPTVN1PROD with NOTICES 11208 Federal Register / Vol. 78, No. 32 / Friday, February 15, 2013 / Notices Location: 5630 Fishers Lane, FDA Conference Room 1066, Rockville, MD 20857. For those unable to attend in person, the meeting will also be Webcast. The Web cast will be available at the following link https://fda.yorkcast. com/webcast/Viewer/ ?peid=63bc1bd2838040b48 eb7db7cbedfc4191d. Contact Person: Bryan Emery or Rosanna Harvey, Center for Biologics Evaluation and Research (HFM–71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301–827–1277 or 301–827–1297, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site at https://www.fda. gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: On March 14, 2013, the Committee will meet in open session to discuss FDA’s draft risk assessment model for potential exposure to the variant Creutzfeldt-Jakob disease (vCJD) agent in Red Blood Cells for transfusion in the United States. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before March 7, 2013. On March 14, 2013, oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of VerDate Mar<15>2010 19:09 Feb 14, 2013 Jkt 229001 proposed participants, and an indication of the approximate time requested to make their presentation on or before February 27, 2013. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by February 28, 2013. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. Seating for this meeting may be limited, so the public is encouraged to watch the free Webcast if you are unable to attend. The link for the Webcast will be available beginning at 8 a.m. on March 14, 2013 (see Location). FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Bryan Emery at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/Advisory Committees/AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: February 12, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–03577 Filed 2–14–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on March 20, 2013, from 8 a.m. to 6 p.m. Location: Holiday Inn, Ballroom, Two Montgomery Village Ave., Gaithersburg, MD 20879. The hotel’s phone number is 301–948–8900. Contact Person: Jamie Waterhouse, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site at https:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: On March 20, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the MitraClip Delivery System sponsored by Abbott Vascular. The system consists of three major components: The delivery catheter, the steerable sleeve, and the MitraClip device. The MitraClip device is a single sized, percutaneously implanted mechanical clip for the reduction of mitral regurgitation. The MitraClip device grasps and coapts the mitral valve leaflets resulting in fixed approximation of the mitral leaflets throughout the cardiac cycle. The implantable MitraClip device is fabricated with metal alloys and polyester fabric (Clip cover) that are commonly used in cardiovascular implants. The proposed indication for use: The MitraClip Delivery System is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR≥3) in patients who have been determined by a cardiac surgeon to be too high risk for open mitral valve surgery and in whom existing comorbidities would not E:\FR\FM\15FEN1.SGM 15FEN1

Agencies

[Federal Register Volume 78, Number 32 (Friday, February 15, 2013)]
[Notices]
[Pages 11207-11208]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03577]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]


Transmissible Spongiform Encephalopathies Advisory Committee; 
Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Transmissible Spongiform Encephalopathies 
Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on March 14, 2013, from 8 
a.m. to 4 p.m.

[[Page 11208]]

    Location: 5630 Fishers Lane, FDA Conference Room 1066, Rockville, 
MD 20857. For those unable to attend in person, the meeting will also 
be Webcast. The Web cast will be available at the following link https://fda.yorkcast.com/webcast/Viewer/?peid=63bc1bd2838040b48eb7db7cbedfc4191d.
    Contact Person: Bryan Emery or Rosanna Harvey, Center for Biologics 
Evaluation and Research (HFM-71), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852, 301-827-1277 or 301-827-1297, or 
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 
in the Washington, DC area). A notice in the Federal Register about 
last minute modifications that impact a previously announced advisory 
committee meeting cannot always be published quickly enough to provide 
timely notice. Therefore, you should always check the Agency's Web site 
at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to 
the appropriate advisory committee meeting link, or call the advisory 
committee information line to learn about possible modifications before 
coming to the meeting.
    Agenda: On March 14, 2013, the Committee will meet in open session 
to discuss FDA's draft risk assessment model for potential exposure to 
the variant Creutzfeldt-Jakob disease (vCJD) agent in Red Blood Cells 
for transfusion in the United States.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before 
March 7, 2013. On March 14, 2013, oral presentations from the public 
will be scheduled between approximately 1 p.m. and 2 p.m. Those 
individuals interested in making formal oral presentations should 
notify the contact person and submit a brief statement of the general 
nature of the evidence or arguments they wish to present, the names and 
addresses of proposed participants, and an indication of the 
approximate time requested to make their presentation on or before 
February 27, 2013. Time allotted for each presentation may be limited. 
If the number of registrants requesting to speak is greater than can be 
reasonably accommodated during the scheduled open public hearing 
session, FDA may conduct a lottery to determine the speakers for the 
scheduled open public hearing session. The contact person will notify 
interested persons regarding their request to speak by February 28, 
2013.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets. Seating for this meeting may be limited, so the public is 
encouraged to watch the free Webcast if you are unable to attend. The 
link for the Webcast will be available beginning at 8 a.m. on March 14, 
2013 (see Location).
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Bryan Emery at least 
7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: February 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03577 Filed 2-14-13; 8:45 am]
BILLING CODE 4160-01-P

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