Science Board to the Food and Drug Administration; Notice of Meeting, 13410 [E6-3639]

Download as PDF 13410 Federal Register / Vol. 71, No. 50 / Wednesday, March 15, 2006 / Notices (NDA 21–060) was initially submitted on December 28, 1999. 3. The date the application was approved: December 28, 2004. FDA has verified the applicant’s claim that NDA 21–060 was approved on December 28, 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 applications for patent extension, this applicant seeks 1,228 days (U.S. Patent No. 5,795,864) and 5 years (U.S. Patent No. 5,364,842) 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 May 15, 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 September 11, 2006. 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 are to 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. Dated: February 13, 2006. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E6–3712 Filed 3–14–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES sroberts on PROD1PC70 with NOTICES Food and Drug Administration Science Board to the Food and Drug Administration; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. VerDate Aug<31>2005 17:27 Mar 14, 2006 Jkt 208001 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: Science Board to the Food and Drug Administration Science Board (Science Board). General Function of the Committee: The Science Board provides advice primarily to the Commissioner of Food and Drugs and other appropriate officials on specific complex and technical issues as well as emerging issues within the scientific community in industry and academia. Additionally, the Science Board provides advice to the agency on keeping pace with technical and scientific evolutions in the fields of regulatory science, on formulating an appropriate research agenda, and on upgrading it’s scientific and research facilities to keep pace with these changes. It will also provide the means for critical review of agency sponsored intramural and extramural scientific research programs. Date and Time: The meeting will be held on March 31, 2006, from 8 a.m. to 4 p.m. Location: Food and Drug Administration, rm. 1066, 5630 Fishers Lane, Rockville, MD 20857. Contact Person: Jan Johannessen, Office of the Commissioner, Food and Drug Administration (HF–33), 5600 Fishers Lane, Rockville, MD 20857, 301–827–6687, Jan.Johannessen@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512603. Please call the Information Line for up-to-date information on this meeting. Agenda: The Science Board will conclude their discussion on drug safety from the meeting of November 4, 2005, and will hear about and discuss a request by the agency for a review of the agency’s science programs. The Science Board will then hear about and discuss the agency’s response to the recommendations contained in the Science Board’s peer review of the Office of Regulatory Affairs Pesticide Program, plans for a Science Board peer review of the Center for Veterinary Medicine’s intramural portion of the National Antimicrobial Resistance Monitoring System, and the science priorities of the agency’s Office of Women’s Health. 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 by March 24, 2006. Oral PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before March 24, 2006, 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. 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 Jan Johannessen (see Contact Person) 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: March 7, 2006. Jason Brodsky, Acting Associate Commissioner for External Relations. [FR Doc. E6–3639 Filed 3–14–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D–0004] Guidance for Industry on Nonclinical Safety Evaluation of Drug or Biologic Combinations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Nonclinical Safety Evaluation of Drug or Biologic Combinations.’’ This guidance provides recommendations on nonclinical approaches to support the clinical study and approval of fixeddose combination products (FDCs), copackaged products, and some adjunctive therapies. DATES: Submit written or electronic comments on agency guidances at any time. Submit written requests for single copies of this guidance to the Division of Drug Information (HFD– ADDRESSES: E:\FR\FM\15MRN1.SGM 15MRN1

Agencies

[Federal Register Volume 71, Number 50 (Wednesday, March 15, 2006)]
[Notices]
[Page 13410]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-3639]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Science Board to the Food and Drug Administration; 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: Science Board to the Food and Drug 
Administration Science Board (Science Board).
    General Function of the Committee: The Science Board provides 
advice primarily to the Commissioner of Food and Drugs and other 
appropriate officials on specific complex and technical issues as well 
as emerging issues within the scientific community in industry and 
academia. Additionally, the Science Board provides advice to the agency 
on keeping pace with technical and scientific evolutions in the fields 
of regulatory science, on formulating an appropriate research agenda, 
and on upgrading it's scientific and research facilities to keep pace 
with these changes. It will also provide the means for critical review 
of agency sponsored intramural and extramural scientific research 
programs.
    Date and Time: The meeting will be held on March 31, 2006, from 8 
a.m. to 4 p.m.
    Location: Food and Drug Administration, rm. 1066, 5630 Fishers 
Lane, Rockville, MD 20857.
    Contact Person: Jan Johannessen, Office of the Commissioner, Food 
and Drug Administration (HF-33), 5600 Fishers Lane, Rockville, MD 
20857, 301-827-6687, Jan.Johannessen@fda.hhs.gov, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), code 3014512603. Please call the Information Line 
for up-to-date information on this meeting.
    Agenda: The Science Board will conclude their discussion on drug 
safety from the meeting of November 4, 2005, and will hear about and 
discuss a request by the agency for a review of the agency's science 
programs. The Science Board will then hear about and discuss the 
agency's response to the recommendations contained in the Science 
Board's peer review of the Office of Regulatory Affairs Pesticide 
Program, plans for a Science Board peer review of the Center for 
Veterinary Medicine's intramural portion of the National Antimicrobial 
Resistance Monitoring System, and the science priorities of the 
agency's Office of Women's Health.
    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 by March 24, 
2006. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. Time allotted for each presentation may 
be limited. Those desiring to make formal oral presentations should 
notify the contact person before March 24, 2006, 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.
    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 Jan Johannessen (see 
Contact Person) 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: March 7, 2006.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. E6-3639 Filed 3-14-06; 8:45 am]
BILLING CODE 4160-01-S

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.