2011-21535. Vaccines and Related Biological Products Advisory Committee; Amendment of Notice

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Vaccines and Related Biological Products Advisory Committee. This meeting was announced in the Federal Register of July 22, 2011 (76 FR 44016). The amendment is being made to reflect a change in the Date and Time, Location, Agenda, Procedure, and Closed Committee Deliberations portions of the document. There are no other changes.

FOR FURTHER INFORMATION CONTACT:

Donald W. Jehn or Denise Royster, Center for Biologics Evaluation and Research (HFM-71), 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), and follow the prompts to the desired center or product area. Please call the Information Line for up-to-date information on this meeting.

SUPPLEMENTARY INFORMATION:

In the Federal Register of July 22, 2011, FDA announced that a meeting of the Vaccines and Related Biological Products Advisory Committee would be held on September 20, 2011. On page 44016, in the 2nd and 3rd column and on page 44017, in the 1st column, the Date and Time, Location, Agenda, Procedure, and Closed Committee Deliberations portions of the document are changed to read as follows:

Date and Time: The meeting will be held on September 20, 2011, from 1 p.m. to approximately 4 p.m.

Location: National Institutes of Health (NIH), 9000 Rockville Pike, Building 29B, Conference Room C, Bethesda, MD 20892. The public is welcome to attend the meeting at the specified location where a speakerphone will be provided. Public participation in the meeting is limited to the use of the speakerphone in the conference room. Important information about transportation and directions to the NIH campus, parking, and security procedures is available on the Internet at http://www.nih.gov/​about/​visitor/​index.htm. (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.) Visitors must show two forms of identification, one of which must be a government-issued photo identification such as a Federal employee badge, driver's license, passport, green card, etc. Detailed information about security procedures is located at http://www.nih.gov/​about/​visitorsecurity.htm. Due to the limited available parking visitors are encouraged to use public transportation.

Agenda: On September 20, 2011, the committee will meet in open session to hear updates of the research programs in the Laboratory of Enteric and Sexually Transmitted Diseases, Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA.

Procedure: On September 20, 2011, from 1 p.m. to approximately 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 September 13, 2011. Oral presentations from the public will be scheduled between approximately 2:30 p.m. and 3:30 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 September 9, 2011. 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 September 10, 2011.

Closed Committee Deliberations: On September 20, 2011, from approximately 3:30 p.m. to approximately 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 the report of the intramural research programs and make recommendations regarding personnel staffing decisions.

This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

Dated: August 18, 2011.

Jill Hartzler Warner,

Acting Associate Commissioner for Special Medical Programs.