Blood Products Advisory Committee; Notice of Meeting, 16023-16024 [E8-6208]

Download as PDF Federal Register / Vol. 73, No. 59 / Wednesday, March 26, 2008 / Notices 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 April 16, 2008. 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 Teresa Watkins 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/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: March 20, 2008. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E8–6193 Filed 3–25–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Blood Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. pwalker on PROD1PC71 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 May 1, 2008, from 8:30 a.m. to 5:30 p.m. and on May 2, 2008, from 8:30 a.m. to 4 p.m. Location: Hilton Hotel, Washington DC/Rockville Executive Meeting Center, 1750 Rockville Pike, Rockville, MD 20852. VerDate Aug<31>2005 18:52 Mar 25, 2008 Jkt 214001 Contact Person: Donald W. Jehn or Pearline K. Muckelvene, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike (HFM–71), 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. 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 the morning of May 1, 2008, the committee will hear updates on the following: (1) Summaries of August 22–23, 2007, and January 9–10, 2008, meetings of the Department of Health and Human Services Advisory Committee on Blood Safety and Availability; (2) 2007 West Nile Virus Epidemiology and the use of nucleic acid tests to reduce the risk of transmission of West Nile Virus in Whole Blood and blood components for transfusion and Human Cells, Tissues, and Cellular and Tissue-based products (HCT/Ps); (3) implementation of blood donor screening for infection with Trypanosoma cruzi and the use of serological tests to reduce the risk of transmission of T. cruzi infection in Whole Blood and blood components for transfusion and HCT/Ps; (4) FDA’s proposal to lower the minimum recommended lot release titer for measles antibodies in Immune Globulin Intravenous (Human) and Immune Globulin Subcutaneous (Human); (5) Gambro/Fenwal Post Approval Surveillance Study of Platelet Outcomes, Release Tested (PASSPORT) Post Marketing Study—7 Day Platelets; (6) Experience with 7 Day Platelets Versus 5 Day Platelets; and (7) FDA Perspective on the PASSPORT Study. These updates will be followed by informational presentations on FDA’s Center for Biologics Evaluation and Research Safety Teams related to blood and tissue. In the afternoon, the committee will discuss the Biomedical Excellence for Safer Transfusion Committee Report on red blood cell recovery standards. On the morning of May 2, 2008, the committee will discuss Lev Pharmaceutical’s plasma-derived C1 esterase inhibitor (CINRYZE). Then, in the afternoon the committee will review PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 16023 the research programs in the Laboratory of Hepatitis and Related Emerging Agents, Division of Emerging and Transfusion Transmitted Diseases, Office of Blood Research and Review, CBER Site Visit of November 8, 2007. 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/ohrms/ dockets/ac/acmenu.htm, click on the year 2008 and scroll down to the appropriate advisory committee link. Procedure: The entire day of May 1, 2008, and on May 2, 2008, from 8:30 a.m. to 3:15 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 April 23, 2008. Oral presentations from the public will be scheduled between approximately 11:50 a.m. and 12:20 p.m. and between approximately 4:20 p.m. and 4:50 p.m. on May 1, 2008, and between approximately 10:40 a.m. and 11:10 a.m. and 2:40 p.m. and 3 p.m. on May 2, 2008. 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 April 15, 2008. 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 April 16, 2008. Closed Committee Deliberations: On May 2, 2008, between 3:15 p.m. and 4 p.m., the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The committee will discuss reports of intramural research programs and make recommendations regarding personnel staffing decisions. Persons attending FDA’s advisory committee meetings are advised that the E:\FR\FM\26MRN1.SGM 26MRN1 16024 Federal Register / Vol. 73, No. 59 / Wednesday, March 26, 2008 / Notices 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. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://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: March 20, 2008. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E8–6208 Filed 3–25–08; 8:45 am] BILLING CODE 4160–01–S 1. On page 11095, in the second column, in the SUPPLEMENTARY INFORMATION section, line twenty-two, the number ‘‘56°’’ is corrected to read ‘‘37.6°’’. Dated: March 18, 2008. Barbara Schneeman, Director, Office of Nutritional Products, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition. [FR Doc. E8–6056 Filed 3–25–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–D–0178] International Conference on Harmonisation; Draft Guidance on S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use; Availability AGENCY: Food and Drug Administration, HHS. ACTION: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0158] (formerly Docket No. FDA–2008–N–0131) Frozen Concentrate for Lemonade Deviating From Identity Standard; Temporary Permit for Market Testing; Correction AGENCY: Food and Drug Administration, HHS. pwalker on PROD1PC71 with NOTICES ACTION: Notice; correction. SUMMARY: The Food and Drug Administration is correcting a notice that appeared in the Federal Register of February 29, 2008 (73 FR 11095). The document announced that a temporary permit has been issued to Florida’s Natural Growers, to market test a product designated as ‘‘Frozen Concentrate for Lemonade 3+1 Ratio.’’ The document was published with an incorrect value for the Brix (measure of concentration of sugars in juice). This document corrects the error. FOR FURTHER INFORMATION CONTACT: Loretta A. Carey, Center for Food Safety and Applied Nutrition (HFS–820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301–436–2371. SUPPLEMENTARY INFORMATION: In FR Doc. E8–3912, appearing on page 11095 in the Federal Register of Friday, February 29, 2008, the following correction is made: VerDate Aug<31>2005 18:52 Mar 25, 2008 Jkt 214001 Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ‘‘S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use.’’ The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance updates and combines information from two ICH guidances, ‘‘S2A Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals’’ and ‘‘S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals.’’ The draft guidance is intended to help facilitate drug development programs, ensure patient safety, and reduce animal usage. 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 May 12, 2008. ADDRESSES: 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 https:// www.regulations.gov. Submit written requests for single copies of the draft PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 guidance to the Division of Drug Information (HFD–240), Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993–0002; or the Office of Communication, Training and Manufacturers Assistance (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852–1448. The draft guidance may also be obtained by mail by calling CBER at 1–800–835–4709 or 301–827–1800. Send two self-addressed adhesive labels to assist the office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Regarding the guidance: David Jacobson-Kram, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6488, Silver Spring, MD 20993–0002, 301– 796–0175. Regarding the ICH: Michelle Limoli, Office of International Programs (HFG– 1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–4480. SUPPLEMENTARY INFORMATION: I. Background In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies. ICH was organized to provide an opportunity for tripartite harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products among three regions: The European Union, Japan, and the United States. The six ICH sponsors are the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese E:\FR\FM\26MRN1.SGM 26MRN1

Agencies

[Federal Register Volume 73, Number 59 (Wednesday, March 26, 2008)]
[Notices]
[Pages 16023-16024]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-6208]


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

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.

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

    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 May 1, 2008, from 8:30 
a.m. to 5:30 p.m. and on May 2, 2008, from 8:30 a.m. to 4 p.m.
    Location: Hilton Hotel, Washington DC/Rockville Executive Meeting 
Center, 1750 Rockville Pike, Rockville, MD 20852.
    Contact Person: Donald W. Jehn or Pearline K. Muckelvene, Center 
for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 1401 Rockville Pike (HFM-71), 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. 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 the morning of May 1, 2008, the committee will hear 
updates on the following: (1) Summaries of August 22-23, 2007, and 
January 9-10, 2008, meetings of the Department of Health and Human 
Services Advisory Committee on Blood Safety and Availability; (2) 2007 
West Nile Virus Epidemiology and the use of nucleic acid tests to 
reduce the risk of transmission of West Nile Virus in Whole Blood and 
blood components for transfusion and Human Cells, Tissues, and Cellular 
and Tissue-based products (HCT/Ps); (3) implementation of blood donor 
screening for infection with Trypanosoma cruzi and the use of 
serological tests to reduce the risk of transmission of T. cruzi 
infection in Whole Blood and blood components for transfusion and HCT/
Ps; (4) FDA's proposal to lower the minimum recommended lot release 
titer for measles antibodies in Immune Globulin Intravenous (Human) and 
Immune Globulin Subcutaneous (Human); (5) Gambro/Fenwal Post Approval 
Surveillance Study of Platelet Outcomes, Release Tested (PASSPORT) Post 
Marketing Study--7 Day Platelets; (6) Experience with 7 Day Platelets 
Versus 5 Day Platelets; and (7) FDA Perspective on the PASSPORT Study. 
These updates will be followed by informational presentations on FDA's 
Center for Biologics Evaluation and Research Safety Teams related to 
blood and tissue. In the afternoon, the committee will discuss the 
Biomedical Excellence for Safer Transfusion Committee Report on red 
blood cell recovery standards. On the morning of May 2, 2008, the 
committee will discuss Lev Pharmaceutical's plasma-derived C1 esterase 
inhibitor (CINRYZE). Then, in the afternoon the committee will review 
the research programs in the Laboratory of Hepatitis and Related 
Emerging Agents, Division of Emerging and Transfusion Transmitted 
Diseases, Office of Blood Research and Review, CBER Site Visit of 
November 8, 2007.
    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/ohrms/dockets/ac/acmenu.htm, click on 
the year 2008 and scroll down to the appropriate advisory committee 
link.
    Procedure: The entire day of May 1, 2008, and on May 2, 2008, from 
8:30 a.m. to 3:15 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 April 23, 2008. Oral presentations 
from the public will be scheduled between approximately 11:50 a.m. and 
12:20 p.m. and between approximately 4:20 p.m. and 4:50 p.m. on May 1, 
2008, and between approximately 10:40 a.m. and 11:10 a.m. and 2:40 p.m. 
and 3 p.m. on May 2, 2008. 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 April 15, 2008. 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 April 16, 
2008.
    Closed Committee Deliberations: On May 2, 2008, between 3:15 p.m. 
and 4 p.m., the meeting will be closed to permit discussion where 
disclosure would constitute a clearly unwarranted invasion of personal 
privacy (5 U.S.C. 552b(c)(6)). The committee will discuss reports of 
intramural research programs and make recommendations regarding 
personnel staffing decisions.
    Persons attending FDA's advisory committee meetings are advised 
that the

[[Page 16024]]

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.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at https://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: March 20, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-6208 Filed 3-25-08; 8:45 am]
BILLING CODE 4160-01-S

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