|CBER||April 4-5, 2017||April 4, 2017 from 08:30 a.m. to 3:45 p.m.|
April 5, 2017 from 08:30 a.m. to 12 p.m.
|Tommy Douglas Conference Center,|
10000 New Hampshire Avenue,
Silver Spring, MD 20903
On April 4, 2017, in open session, the Committee will discuss Recombinant Human Coagulation Factor IX, GlycoPEGylated. In the afternoon, in open session, the Committee will hear an update presentation on a summary of responses to Docket FDA-2016-N-1502: Blood Donor Deferral Policy for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products.
On April 5, 2017, in open session, the committee will hear overview presentations on the research programs in the Laboratory of Emerging Pathogens in the Division of Emerging Transfusion-Transmitted Diseases, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA. At the conclusion of the open session, the meeting will be closed to permit discussion where disclosure would constitute an unwarranted invasion of personal privacy in accordance with 5 U.S.C 552b(c)(6). During the closed session, the Committee will discuss the research progress made by staff involved in the intramural research programs and make recommendations regarding their personnel actions and staffing decisions.
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.
Materials for this meeting will be available at: the Advisory Committee calendar main page.. Scroll down to the appropriate advisory committee meeting link.
Public Participation Information
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 March 28, 2017
- Oral presentations from the public will be scheduled on April 4, 2017 between approximately 10:50 a.m. to 11:20 a.m. and 3:15 p.m. to 3:45 p.m.
- Oral presentations from the public will be scheduled on April 5, 2017 between approximately 10:15 a.m. to 11:15 a.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 March 20, 2017. 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 March 21, 2017.
For those unable to attend in person, the meeting will also be Web cast. The Web cast will be available at the following links:
April 4, 2017, 115th Meeting of the Blood Products Advisory Committee- Day 1
April 5, 2017, 115th Meeting of the Blood Products Advisory Committee- Day 2.
Closed Committee Deliberations
On April 5, 2017, between approximately 11:15 a.m. and 12:00 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 the report of the intramural research programs and make recommendations regarding personnel staffing decisions.
- LCDR Bryan Emery or Joanne Lipkind
10903 New Hampshire Ave., Bldg. 71, rm. 6268, Silver Spring, MD 20993-0002,
240-402-8054; e-mail: email@example.com or email:firstname.lastname@example.org
- FDA Advisory Committee Information Line
1-800-741-8138 (301-443-0572 in the Washington, DC, 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.
Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. Seating for this meeting may be limited; the public is encouraged to watch the free webcast at the link above if unable to attend. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact LCDR Bryan Emery or Joanne Lipkind 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 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). Official FR Notice