Blood Products Advisory Committee; Notice of Meeting, 4567-4568 [2012-1888]

Download as PDF emcdonald on DSK29S0YB1PROD with NOTICES Federal Register / Vol. 77, No. 19 / Monday, January 30, 2012 / Notices indication of long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. 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/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee link. 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 February 8, 2012. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those individuals interested in making 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 January 31, 2012. 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 February 1, 2012. 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 Nicole Vesely 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/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on VerDate Mar<15>2010 15:09 Jan 27, 2012 Jkt 226001 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: January 24, 2012. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2012–1889 Filed 1–27–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0001] 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). The meeting will be open 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. DATES: Date and Time: The meeting will be held on February 29, 2012, from 8:30 a.m. to 4 p.m. Location: Hilton Washington DC North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 20877, (301) 977– 8900. For those unable to attend in person, the meeting will also be Web cast. The Blood Products Advisory Committee Web cast will be available at https://fda.yorkcast.com/webcast/ Viewer/?peid=11253ea88 a9041e5a91883236f342bfc1d. Contact Person: Bryan Emery or Pearl Muckelvene, Center for Biologics Evaluation and Research (HFM–71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, (301) 827–1281, or FDA Advisory Committee Information Line, 1-(800) 741–8138 (301) 443–0572 in the Washington, DC area), and follow the prompts to the desired center or product area. 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 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 4567 call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: On February 29, 2012, the committee will discuss the evaluation of possible new plasma products manufactured following storage at room temperature for up to 24 hours, namely, plasma for transfusion prepared from whole blood held at room temperature for up to 24 hours prior to separation and freezing, or from apheresis plasma held at room temperature for up to 24 hours before freezing. In the afternoon, the committee will hear the following updates: Report from the Health and Human Services Advisory Committee on Blood Safety and Availability and summary of the December 5–6, 2011, meeting; update on HHS activities related to the evaluation of the donor deferral policy for men who have had sex with other men; summary of the November 8–9, 2011, public workshop on hemoglobin standard and maintaining an adequate blood supply; summary of the November 29, 2011, public workshop on data and data needs to advance risk assessment for emerging infectious diseases for blood and blood products; and an update on thrombotic adverse events and immune globulin products. 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/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee link. 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 February 21, 2012. Oral presentations from the public will be scheduled between approximately 11:15 a.m. and 12:45 p.m. on February 29, 2012. Those individuals interested in making 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 February 13, 2012. Time allotted for each presentation may be E:\FR\FM\30JAN1.SGM 30JAN1 4568 Federal Register / Vol. 77, No. 19 / Monday, January 30, 2012 / Notices 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 February 14, 2012. 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 Bryan Emery or Pearl 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/Advisory Committees/AboutAdvisoryCommittees/ ucm111462.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: January 24, 2012. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2012–1888 Filed 1–27–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0001] Annual Computational Science Symposium; Public Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. The Food and Drug Administration (FDA), in cosponsorship with the Pharmaceutical Users Software Exchange (PhUSE), is announcing a public conference entitled ‘‘The FDA/ PhUSE Annual Computational Science Symposium.’’ The purpose of the conference is to help the broader community align and share experiences to advance computational science. At the conference, which will bring together FDA, industry, and academia, FDA will update participants on current initiatives, and collaborative working emcdonald on DSK29S0YB1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 15:09 Jan 27, 2012 Jkt 226001 groups will address specific challenges in accessing and reviewing data to support product development. These working groups will focus on solutions and practical ways to implement them. DATES: Date and Time: The public conference will be held on March 19 and 20, 2012, from 9 a.m. to 4:30 p.m. Location: The public conference will be held at the Silver Spring Civic Building at Veterans Plaza, One Veterans Pl., Silver Spring, MD 20910, 1–(240)–777–5300. Contact: Chris Decker, U.S. Regional Director, Pharmaceutical Users Software Exchange (PhUSE), 64 High St., BROADSTAIRS CT10 1JT, United Kingdom, (202) 386–6722, e-mail: office@phuse.eu. SUPPLEMENTARY INFORMATION: I. Working Groups and Their Areas of Focus Six working groups will address particular challenges related to the access and review of data to support product development: • Working Group 1: Data Validation and Quality Assessment, • Working Group 2: Reducing Risk Within the Inspection Site Selection Process, • Working Group 3: Challenges of Integrating and Converting Data Across Studies, • Working Group 4: Standards Implementation Issues With the Clinical Data Interchange Standards Consortium Data Models, • Working Group 5: Development of Standard Scripts for Analysis and Programming, and • Working Group 6: ‘‘Non-Clinical Road-Map’’ and Impacts on Implementation. A description of the planned activities of the working groups can be found at https://www.phuse.eu/WorkingGroups.aspx. (FDA has verified the Web site addresses throughout this document, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) II. Registration and Accommodations A. Registration To register, please submit the registration form online at https:// www.phuse.eu/PhUSE-Conference2012-Registration.aspx. Registration fees cover the cost of facilities, materials, and food functions. Seats are limited, and conference space will be filled in the order in which registrations are received. Onsite registration will be available to the extent that space is available on the day of the conference. PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 The costs of registration for different categories of attendee are as follows: COST OF REGISTRATION Category Industry representatives registering by January 15, 2012 ..................... Industry representatives registering after January 15, 2012 .................. Those with Government affiliation .... Representatives of nonprofit organizations ........................................... Those attending for a single day ...... Cost $750 950 300 600 650 Government and nonprofit attendees and exhibitors will need an invitation code to register at the discounted rate. An invitation code can be obtained by sending an email to: office@phuse.eu. All registrants will pay a fee with the exception of a limited number of speakers/organizers who will have a complimentary registration. B. Accommodations Attendees are responsible for their own accommodations. Attendees making reservations at the Courtyard by Marriott Silver Spring Downtown Hotel are eligible for a reduced conference rate of $199, not including applicable taxes. Those making reservations online should use the group code ‘‘SPRSPRB’’ to receive the special rate. If you need special accommodations because of disability, please contact Chris Decker (see Contact) at least 7 days before the meeting. III. Posters and Exhibits Information Posters will be presented and may include demonstrations to provide an interactive experience. Although PhUSE welcomes demonstrations to support and explore the posters that are presented, neither PhUSE nor FDA endorse any commercial software or vendor. The creator of what is judged the best poster will be recognized and offered the opportunity to present the poster at the closing session. Poster topics include: • Data submission standards development, implementation, and best practices; • User experience and evaluation of current processes and tools and their effects on organizational performance; • Needs and specifications for proposed new tools and processes; • Business processes driving the development of information systems; and • The effect of processes and tools on problem solving quality, efficiency, and cost. E:\FR\FM\30JAN1.SGM 30JAN1

Agencies

[Federal Register Volume 77, Number 19 (Monday, January 30, 2012)]
[Notices]
[Pages 4567-4568]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-1888]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]


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). The meeting will 
be open 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.

DATES: Date and Time: The meeting will be held on February 29, 2012, 
from 8:30 a.m. to 4 p.m.
    Location: Hilton Washington DC North/Gaithersburg, 620 Perry Pkwy., 
Gaithersburg, MD 20877, (301) 977-8900. For those unable to attend in 
person, the meeting will also be Web cast. The Blood Products Advisory 
Committee Web cast will be available at https://fda.yorkcast.com/webcast/Viewer/?peid=11253ea88a9041e5a91883236f342bfc1d.
    Contact Person: Bryan Emery or Pearl Muckelvene, Center for 
Biologics Evaluation and Research (HFM-71), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852, (301) 827-
1281, or FDA Advisory Committee Information Line, 1-(800) 741-8138 
(301) 443-0572 in the Washington, DC area), and follow the prompts to 
the desired center or product area. 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 February 29, 2012, the committee will discuss the 
evaluation of possible new plasma products manufactured following 
storage at room temperature for up to 24 hours, namely, plasma for 
transfusion prepared from whole blood held at room temperature for up 
to 24 hours prior to separation and freezing, or from apheresis plasma 
held at room temperature for up to 24 hours before freezing. In the 
afternoon, the committee will hear the following updates: Report from 
the Health and Human Services Advisory Committee on Blood Safety and 
Availability and summary of the December 5-6, 2011, meeting; update on 
HHS activities related to the evaluation of the donor deferral policy 
for men who have had sex with other men; summary of the November 8-9, 
2011, public workshop on hemoglobin standard and maintaining an 
adequate blood supply; summary of the November 29, 2011, public 
workshop on data and data needs to advance risk assessment for emerging 
infectious diseases for blood and blood products; and an update on 
thrombotic adverse events and immune globulin products.
    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/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
    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 
February 21, 2012. Oral presentations from the public will be scheduled 
between approximately 11:15 a.m. and 12:45 p.m. on February 29, 2012. 
Those individuals interested in making 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 
February 13, 2012. Time allotted for each presentation may be

[[Page 4568]]

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 February 
14, 2012.
    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 Bryan Emery or Pearl 
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/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.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: January 24, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-1888 Filed 1-27-12; 8:45 am]
BILLING CODE 4160-01-P

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