13646 Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Vaccines and Related Biological 

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: Vaccines and 

Related Biological 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 April 6, 2011, between 

approximately 9 a.m. and 4 p.m. and on 

April 7, 2011, between approximately 

8:30 a.m. and 3:30 p.m. 

Location: Hilton Hotel, Washington 

DC North/Gaithersburg, 620 Perry 

Pkwy., Gaithersburg, MD 20877. 

Contact Person: 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. 

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 April 6, 

2011, the committee will meet in open 

session to hear updates of the research 

programs in the Laboratory of Bacterial 

Polysaccharides, Division of Bacterial, 

Parasitic, and Allergenic Products, 

Office of Vaccines Research and Review, 

Center for Biologics Evaluation and 

Research, FDA. In the afternoon of April 

6, 2011, the committee will meet in 

open session and will be briefed on the 

use of immunological markers for 

demonstration of effectiveness of 

meningococcal serogroups A, C, Y, and 

W–135 conjugate vaccines administered 

to children less than 2 years of age. On 

April 7, 2011, the committee will meet 

in open session to review and discuss 

approaches to licensure of 

meningococcal serogroup B vaccines. 

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 http://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee link. 

Procedure: On April 6, 2011, from 

approximately 9 a.m to 10:50 a.m. and 

from approximately 12:30 p.m to 4 p.m., 

the meeting is open to the public. On 

April 7, 2011, the entire 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 March 30, 2011. 

Oral presentations from the public will 

be scheduled between approximately 

10:20 a.m. and 10:50 a.m. and between 

approximately 2:30 p.m. and 3 p.m. on 

April 6, 2011, and between 

approximately 1:30 p.m. and 2 p.m. on 

April 7, 2011. 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 

22, 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 March 23, 2011. 

Closed Committee Deliberations: On 

April 6, 2011, between approximately 

10:50 a.m. and 11:30 a.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. 

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 Denise Royster 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 

http://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: March 4, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–5727 Filed 3–11–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Statement of Delegation of Authority 

Notice is hereby given that I have 

delegated to the Administrator, Health 

Resources and Services Administration 

(HRSA), authority vested in the 

Secretary under Title XX, Section 

2008(b) of the Social Security Act (42 

U.S.C. 1397g(b)), as added by Section 

5507(a) of the Affordable Care Act, as it 

pertains to the functions assigned to 

HRSA. This authority may be 

redelegated. 

HRSA will consult with the Assistant 

Secretary for Planning and Evaluation, 

as appropriate, in implementing this 

authority. 

This delegation excludes the authority 

to issue regulations, to establish 

advisory councils and committees and 

appoint their members, and to submit 

reports to Congress, and shall be 

exercised in accordance with the 

Department’s applicable policies, 

procedures, and guidelines. In addition, 

I hereby affirm and ratify any actions 

taken by the Administrator, HRSA, or 

other HRSA officials, which involved 

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