National Mammography Quality Assurance Advisory Committee; Notice of Meeting, 44035 [E6-12569]

Download as PDF Federal Register / Vol. 71, No. 149 / Thursday, August 3, 2006 / Notices 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the act: November 13, 2001. FDA has verified the applicant’s claim that the new drug application (NDA) for CYMBALTA (NDA 21–427) was initially submitted on November 13, 2001. 3. The date the application was approved: August 3, 2004. FDA has verified the applicant’s claim that NDA 21–427 was approved on August 3, 2004. 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 application for patent extension, this applicant seeks 1,826 days 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 October 2, 2006. 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 January 30, 2007. 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. hsrobinson on PROD1PC69 with NOTICES Dated: July 20, 2006. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E6–12574 Filed 8–2–06; 8:45 am] BILLING CODE 4160–01–S VerDate Aug<31>2005 18:02 Aug 02, 2006 Jkt 208001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration National Mammography Quality Assurance 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: National Mammography Quality Assurance 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 September 28, 2006, from 10 a.m. to 6 p.m., and on September 29, 2006, from 8 a.m. to 1 p.m. Location: Atrium Court Hotel, Remington 1 and 2, Three Research Ct., Rockville, MD. Contact Person: Nancy Wynne, Center for Devices and Radiological Health (HFZ–240), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 240–276–3284, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512397. Please call the Information Line for up-to-date information on this meeting. Agenda: The committee will discuss: (1) Amendments to the current regulations, and (2) all guidance documents issued since the last meeting. The committee will also receive updates on recently approved alternative standards and the radiological health program. MQSA regulations and guidance documents are available to the public on the Internet at https://www.fda.gov/cdrh/ mammography. 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 August 29, 2006. Oral presentations from the public will be scheduled between approximately 10:30 a.m. and 11:30 a.m. on September 28, 2006, and between approximately 8:30 a.m. and 9:30 a.m. on September 29, 2006. Time allotted for each presentation may be limited. Those PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 44035 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 August 29, 2006. 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 accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Shirley Meeks, Conference Management Staff, at 301–827–7292, at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: July 27, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–12569 Filed 8–2–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 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 September 18, 2006, from 8 a.m. to 4:30 p.m. and September 19, 2006, from 8 a.m. to 1 p.m. Location: Holiday Inn Gaithersburg, Two Montgomery Village Ave., Gaithersburg, MD. Contact Person: William Freas or Rosanna Harvey, Center for Biologics Evaluation and Research (HFM–71), E:\FR\FM\03AUN1.SGM 03AUN1

Agencies

[Federal Register Volume 71, Number 149 (Thursday, August 3, 2006)]
[Notices]
[Page 44035]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-12569]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


National Mammography Quality Assurance 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: National Mammography Quality Assurance 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 September 28, 2006, from 
10 a.m. to 6 p.m., and on September 29, 2006, from 8 a.m. to 1 p.m.
    Location: Atrium Court Hotel, Remington 1 and 2, Three Research 
Ct., Rockville, MD.
    Contact Person: Nancy Wynne, Center for Devices and Radiological 
Health (HFZ-240), Food and Drug Administration, 1350 Piccard Dr., 
Rockville, MD 20850, 240-276-3284, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 3014512397. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: The committee will discuss: (1) Amendments to the current 
regulations, and (2) all guidance documents issued since the last 
meeting. The committee will also receive updates on recently approved 
alternative standards and the radiological health program. MQSA 
regulations and guidance documents are available to the public on the 
Internet at https://www.fda.gov/cdrh/mammography.
    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 
August 29, 2006. Oral presentations from the public will be scheduled 
between approximately 10:30 a.m. and 11:30 a.m. on September 28, 2006, 
and between approximately 8:30 a.m. and 9:30 a.m. on September 29, 
2006. Time allotted for each presentation may be limited. 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 August 29, 2006.
    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 accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Shirley Meeks, 
Conference Management Staff, at 301-827-7292, at least 7 days in 
advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: July 27, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-12569 Filed 8-2-06; 8:45 am]
BILLING CODE 4160-01-S

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