Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 63617-63618 [E7-21979]

Download as PDF Federal Register / Vol. 72, No. 217 / Friday, November 9, 2007 / Notices 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 63617 of safety and effectiveness data were placed on the Internet from July 1, 2007, through September 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 JULY 1, 2007, THROUGH SEPTEMBER 30, 2007. PMA No./Docket No. Applicant Trade Name BP060001/0/2007M–0366 ThermoGenesis Corp. II. Electronic Access Persons with access to the Internet may obtain the documents at http:// www.fda.gov/cber/products.htm. Line for up-to-date information on this meeting. 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 and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: On December 13, 2007, the committee will discuss, make recommendations, and vote on a premarket approval application for the Adiana Transcervical Sterilization System, sponsored by Cytyc Surgical Products. This device is indicated to be used as a permanent method for female sterilization. On December 14, 2007, the committee will have a general topic discussion of clinical trial design issues for endometrial ablation devices indicated for pre-menopausal women in whom childbearing is complete and who no longer desire menses (i.e., monthly period). The committee will also hear and discuss a post-approval study update for the ExAblate 2000 System from InSightec, Inc. The system is indicated for ablation of uterine fibroid tissue in pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. 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 http://www.fda.gov/ohrms/ dockets/ac/acmenu.htm, click on the year 2007 and scroll down to the appropriate advisory committee link. Dated: October 31, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–21986 Filed 11–8–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. mstockstill on PROD1PC66 with NOTICES ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public. Name of Committee: Obstetrics and Gynecology 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 December 13, 2007, from 8 a.m. to 5 p.m., and on December 14, 2007, from 8 a.m. to 1:15 p.m. Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and C, 620 Perry Pkwy., Gaithersburg, MD. Contact Person: Michael Bailey, Center for Devices and Radiological Health (HFZ–470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240–276–4100, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512524. Please call the Information VerDate Aug<31>2005 23:48 Nov 08, 2007 Jkt 214001 PO 00000 Frm 00071 Fmt 4703 CryoSeal FS System Sfmt 4703 Approval Date 7/26/2007 Procedure: On December 13, 2007, from 8 a.m. to 5 p.m., and on December 14, 2007, from 9 a.m. to 1:15 p.m., the meeting is open to the public. 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 November 29, 2007. Oral presentations from the public will be scheduled on December 13, 2007, between approximately 8:15 a.m. and 8:45 a.m. and between approximately 3:30 p.m. and 4 p.m., and on December 14, 2007, between approximately 10 a.m. and 10:15 a.m. and between approximately 11:15 a.m. and 12:15 p.m. Those desiring to make 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 November 21, 2007. 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 November 23, 2007. Closed Presentation of Data: On December 14, 2007, from 8 a.m. to 9 a.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)). The committee will hear an update on device submissions currently under review. Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to E:\FR\FM\09NON1.SGM 09NON1 63618 Federal Register / Vol. 72, No. 217 / Friday, November 9, 2007 / Notices accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact AnnMarie Williams, Conference Management Staff, at 240–276–8932, 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 http://www.fda.gov/oc/advisory/ default.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: November 2, 2007. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E7–21979 Filed 11–8–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D–0419] Draft Guidance for Industry on Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment; Availability AGENCY: Food and Drug Administration, HHS. mstockstill on PROD1PC66 with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment.’’ This guidance is intended to assist the pharmaceutical industry in designing a clinical development program for new drugs for the treatment of chronic obstructive pulmonary disease (COPD). The emphasis of this guidance is on the assessment of efficacy of a new molecular entity in phase 3 clinical studies of COPD. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by January 8, 2008. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information (HFD– 240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, VerDate Aug<31>2005 23:48 Nov 08, 2007 Jkt 214001 Rockville, MD 20857. Send one selfaddressed adhesive label to assist that office in processing your requests. Submit written comments on the draft guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http:// www.fda.gov/dockets/ecomments or http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Badrul A. Chowdhury, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 3316, Silver Spring, MD 20993–0002, 301– 796–2300. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment.’’ This guidance is intended to assist the pharmaceutical industry in designing a clinical development program for new drugs for the treatment of COPD. The emphasis of this guidance is on the assessment of efficacy of a new molecular entity in phase 3 clinical studies of COPD. There is pressing need to develop new drugs for COPD because the global prevalence of COPD is rising, the disease is associated with significant morbidity and mortality, and current treatment options are limited. The currently available drugs for COPD are mostly for symptomatic treatment and have not been conclusively shown to alter the underlying inflammation or to alter disease progression. The principles of development applied to COPD drugs have been generally derived from those used to develop drugs for asthma, with the primary focus aimed at demonstrating improvements in airway obstruction. With improved understanding of the pathophysiology and clinical manifestations of COPD, and the awareness of the importance of inflammation in COPD and how this inflammation differs from that occurring in asthma, this is an appropriate time to define characteristics of specific drug development programs for COPD. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency’s current thinking on developing drugs for the treatment of COPD. It does not create or confer any PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 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 statutes and regulations. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified 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. III. Electronic Access Persons with access to the Internet may obtain the document at either http://www.fda.gov/cder/guidance/ index.htm or http://www.fda.gov/ ohrms/dockets/default.htm. Dated: November 2, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–21985 Filed 11–8–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Advisory Council on Nurse Education and Practice; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), notice is hereby given of the following meeting: Name: National Advisory Council on Nurse Education and Practice (NACNEP). Dates and Times: November 15, 2007, 9 a.m.–5 p.m. November 16, 2007, 9 a.m.–4 p.m. Place: Doubletree Executive Hotel and Meeting Center, 8120 Wisconsin Avenue, Bethesda, MD 20814. Status: The meeting will be open to the public. Agenda: Agency and Bureau administrative updates will be provided. The purpose of the meeting will be to examine the issues facing nursing education in relation to teaching and learning strategies, the needs of employers and consumers for high quality professional nursing care across the lifespan and in a variety of settings, and nursing curricula to prepare the nursing student at the basic level (associate degree, diploma, and baccalaureate degree) to E:\FR\FM\09NON1.SGM 09NON1

Agencies

[Federal Register Volume 72, Number 217 (Friday, November 9, 2007)]
[Notices]
[Pages 63617-63618]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-21979]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Obstetrics and Gynecology 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 of the Food and Drug Administration (FDA). At least one 
portion of the meeting will be closed to the public.
    Name of Committee: Obstetrics and Gynecology 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 December 13, 2007, from 
8 a.m. to 5 p.m., and on December 14, 2007, from 8 a.m. to 1:15 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and 
C, 620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: Michael Bailey, Center for Devices and Radiological 
Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 240-276-4100, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 3014512524. Please call the Information Line for up-to-date 
information on this meeting. 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 
and call the appropriate advisory committee hot line/phone line to 
learn about possible modifications before coming to the meeting.
    Agenda: On December 13, 2007, the committee will discuss, make 
recommendations, and vote on a premarket approval application for the 
Adiana Transcervical Sterilization System, sponsored by Cytyc Surgical 
Products. This device is indicated to be used as a permanent method for 
female sterilization. On December 14, 2007, the committee will have a 
general topic discussion of clinical trial design issues for 
endometrial ablation devices indicated for pre-menopausal women in whom 
childbearing is complete and who no longer desire menses (i.e., monthly 
period). The committee will also hear and discuss a post-approval study 
update for the ExAblate 2000 System from InSightec, Inc. The system is 
indicated for ablation of uterine fibroid tissue in pre- or peri-
menopausal women with symptomatic uterine fibroids who desire a uterine 
sparing procedure.
    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 http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on 
the year 2007 and scroll down to the appropriate advisory committee 
link.
    Procedure: On December 13, 2007, from 8 a.m. to 5 p.m., and on 
December 14, 2007, from 9 a.m. to 1:15 p.m., the meeting is open to the 
public. 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 November 29, 
2007. Oral presentations from the public will be scheduled on December 
13, 2007, between approximately 8:15 a.m. and 8:45 a.m. and between 
approximately 3:30 p.m. and 4 p.m., and on December 14, 2007, between 
approximately 10 a.m. and 10:15 a.m. and between approximately 11:15 
a.m. and 12:15 p.m. Those desiring to make 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 
November 21, 2007. 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 November 23, 
2007.
    Closed Presentation of Data: On December 14, 2007, from 8 a.m. to 9 
a.m., the meeting will be closed to permit discussion and review of 
trade secret and/or confidential information (5 U.S.C. 552b(c)(4)). The 
committee will hear an update on device submissions currently under 
review.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to

[[Page 63618]]

accommodate persons with physical disabilities or special needs. If you 
require special accommodations due to a disability, please contact 
AnnMarie Williams, Conference Management Staff, at 240-276-8932, 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 http://www.fda.gov/oc/advisory/
default.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: November 2, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-21979 Filed 11-8-07; 8:45 am]
BILLING CODE 4160-01-S