Blood Products Advisory Committee; Notice of Meeting, 36813 [06-5870]

Download as PDF Federal Register / Vol. 71, No. 124 / Wednesday, June 28, 2006 / Notices Inspections and reinspections involve the same procedure, require the same amount of time, and are therefore charged at the same rate. [FR Doc. E6–10174 Filed 6–27–06; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Blood Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. jlentini on PROD1PC65 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: Blood Products 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 July 13, 2006, from 8 a.m. to 4:30 p.m. and on July 14, 2006, from 8 a.m. to 3:30 p.m. Location: Hilton Hotel, Washington DC North/Gaithersburg, 620 Perry Pkwy, Gaithersburg, MD 20877. Contact Person: Donald W. Jehn, or Pearline K. Muckelvene, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301–827–0314, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), code 3014519516. Please call the Information Line for up-to-date information on this meeting. Agenda: On July 13, 2006, the Committee will hear updates on the following topics: (1) Summary of the Department of Health and Human Services Advisory Committee on Blood Safety and Availability meeting held on May 9 and 10, 2006; (2) summary of workshop on testing for malarial infections in blood donors to be held on July 12, 2006; (3) Committee report on the office of blood research and review site visit, review of intramural research; (4) west nile virus update and (5) FDA acceptance criteria for in vivo red blood cell survival studies. The Committee will discuss the FDA review of Nabi Biopharmaceuticals’ Hepatitis B Immunoglobulin Intravenous (IGIV) for prevention of recurrent Hepatitis B Virus (HBV) disease after orthotopic VerDate Aug<31>2005 16:52 Jun 27, 2006 Jkt 208001 liver transplantation. In the afternoon the Committee will hear an overview of the research program of the Laboratory of Bacterial, Parasitic and Unconventional Agents, Division of Emerging and Transfusion Transmitted Diseases, OBRR, CBER. On July 14, 2006, from 8 a.m. to 3:30 p.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)). Procedure: On July 13, 2006, from 8 a.m. to 3:30 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 July 5, 2006. Oral presentations from the public will be scheduled between approximately 11 a.m. to 11:30 a.m. and 3 p.m. to 3:30 p.m. on July 13, 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 July 5, 2006. Closed Committee Deliberations: On July 13, 2006, between 3:30 p.m. and 4:30 p.m. the meeting will be closed to permit discussion of information of a personal nature where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c) (6)). The Committee will discuss a review of the individual research programs. On July 14, 2006, the meeting will be closed to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552b(c) (4)). This portion of the meeting will be closed to permit discussion of this material. 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 Donald W. Jehn or Pearline K. Muckelvene 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). PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 36813 Dated: June 20, 2006. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. 06–5870 Filed 6–27–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D–0254] Draft Guidance for Industry: Analytical Methods Description for Type C Medicated Feeds; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of draft guidance for industry (#137) entitled ‘‘Analytical Methods Description for Type C Medicated Feeds.’’ This draft guidance provides our recommendations for describing methods for analyzing new animal drugs in Type C medicated feeds. Submit written or electronic comments on this draft guidance by September 11, 2006 to ensure their adequate consideration in preparation of the final document. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the draft guidance to the Communications Staff (HFV–12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. 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. Comments should be identified with the full title of the draft guidance and the docket number found in brackets in the heading of this document. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Rebecca L. Owen, Center for Veterinary Medicine (HFV–141), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276–9842, email: rebecca.owen@fda.hhs.gov. SUPPLEMENTARY INFORMATION: DATES: E:\FR\FM\28JNN1.SGM 28JNN1

Agencies

[Federal Register Volume 71, Number 124 (Wednesday, June 28, 2006)]
[Notices]
[Page 36813]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-5870]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Blood Products Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    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: Blood Products 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 July 13, 2006, from 8 
a.m. to 4:30 p.m. and on July 14, 2006, from 8 a.m. to 3:30 p.m.
    Location: Hilton Hotel, Washington DC North/Gaithersburg, 620 Perry 
Pkwy, Gaithersburg, MD 20877.
    Contact Person: Donald W. Jehn, or Pearline K. Muckelvene, Center 
for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314, 
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code 3014519516. Please call the 
Information Line for up-to-date information on this meeting.
    Agenda: On July 13, 2006, the Committee will hear updates on the 
following topics: (1) Summary of the Department of Health and Human 
Services Advisory Committee on Blood Safety and Availability meeting 
held on May 9 and 10, 2006; (2) summary of workshop on testing for 
malarial infections in blood donors to be held on July 12, 2006; (3) 
Committee report on the office of blood research and review site visit, 
review of intramural research; (4) west nile virus update and (5) FDA 
acceptance criteria for in vivo red blood cell survival studies. The 
Committee will discuss the FDA review of Nabi Biopharmaceuticals' 
Hepatitis B Immunoglobulin Intravenous (IGIV) for prevention of 
recurrent Hepatitis B Virus (HBV) disease after orthotopic liver 
transplantation. In the afternoon the Committee will hear an overview 
of the research program of the Laboratory of Bacterial, Parasitic and 
Unconventional Agents, Division of Emerging and Transfusion Transmitted 
Diseases, OBRR, CBER. On July 14, 2006, from 8 a.m. to 3:30 p.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)).
    Procedure: On July 13, 2006, from 8 a.m. to 3:30 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 July 5, 2006. Oral presentations from the public will be 
scheduled between approximately 11 a.m. to 11:30 a.m. and 3 p.m. to 
3:30 p.m. on July 13, 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 July 
5, 2006.
    Closed Committee Deliberations: On July 13, 2006, between 3:30 p.m. 
and 4:30 p.m. the meeting will be closed to permit discussion of 
information of a personal nature where disclosure would constitute a 
clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c) 
(6)). The Committee will discuss a review of the individual research 
programs. On July 14, 2006, the meeting will be closed to permit 
discussion and review of trade secret and/or confidential information 
(5 U.S.C. 552b(c) (4)). This portion of the meeting will be closed to 
permit discussion of this material.
    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 Donald W. Jehn or 
Pearline K. Muckelvene 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: June 20, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. 06-5870 Filed 6-27-06; 8:45 am]
BILLING CODE 4160-01-S

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