14414 Federal Register / Vol. 76, No. 51 / Wednesday, March 16, 2011 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Allergenic 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: Allergenic 

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 12, 2011, from 8 a.m. to 

approximately 3:30 p.m. 

Location: Bethesda Doubletree Hotel, 

8120 Wisconsin Ave., Bethesda, MD 

20814, Grand Ballroom. 

Contact Person: Gail Dapolito or Jane 

Brown, Center for Biologics Evaluation 

and Research (HFM–71), Food and Drug 

Administration, 1401 Rockville Pike, 

Rockville, MD 20853, 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 May 12, 2011, in open 

session, the committee will receive 

updates and have discussion on the 

following topics: (1) Structure and 

Activities of the Laboratory of 

Immunobiochemistry (the Laboratory), 

Division of Bacterial, Parasitic, and 

Allergenic Products, Center for 

Biologics Evaluation and Research, 

FDA; (2) enzyme-linked immunosorbent 

assay replacement of radial 

immunodiffusion assays for potency 

determinations of cat and ragweed 

pollen allergen extracts by the 

Laboratory; (3) statistical considerations 

for the design and interpretation of 

phase III clinical trials of allergenic 

products; (4) environmental exposure 

chambers for phase III studies of 

allergenic products, and (5) 

International Organization for 

Standardization (ISO) 17025 

accreditation of the Laboratory. 

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 May 12, 2011, from 8 

a.m. to approximately 3 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 May 5, 2011. Oral 

presentations from the public will be 

scheduled between approximately 11:30 

a.m. and 12:30 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 April 27, 

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 April 28, 2011. 

Closed Committee Deliberations: On 

May 12, 2011, from approximately 3 

p.m. to 3:30 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 a report of 

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 Gail Dapolito 

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 11, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–6083 Filed 3–15–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Docket No. FDA–2011–N–0002] 

Microbiology Devices Panel of the 

Medical Devices 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: Microbiology 

Devices Panel of the Medical Devices 

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 June 29, 2011, from 8 a.m. to 6 

p.m. 

Location: Holiday Inn, Ballroom, 2 

Montgomery Village Ave., Gaithersburg, 

MD. 

Contact Person: Shanika Craig, Center 

for Devices and Radiological Health, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 66, rm. 

1613, Silver Spring, MD 20993–0002, 

301–796–6639, 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. 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 76, No. 51 / Wednesday, March 16, 2011 / Notices 14415 

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 June 29, 2011, the 

committee will discuss and make 

recommendations regarding the possible 

reclassification of molecular diagnostics 

for the rapid detection of 

Mycobacterium tuberculosis complex 

and the detection of genetic mutations 

which confer antibiotic resistance in M. 

tuberculosis complex. Discussion would 

include the appropriate information and 

acceptable performance characteristics 

that would be required to assess the 

safety and effectiveness of rapid 

diagnostic tests for M. tuberculosis 

complex, and whether these can be 

sufficiently specified to support 

possible reclassification. 

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: 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 June 20, 2011. Oral 

presentations from the public will be 

scheduled between approximately 10:30 

a.m. and 11:30 a.m. on June 29, 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 June 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 June 10, 2011. 

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 AnnMarie 

Williams, Committee Management Staff, 

301–796–5966, 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 11, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–6081 Filed 3–15–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

General and Plastic Surgery Devices 

Panel of the Medical Devices 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: General and 

Plastic Surgery Devices Panel of the 

Medical Devices 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 27, 2011, from 8 a.m. to 

6 p.m. 

Location: Holiday Inn, Ballroom, Two 

Montgomery Village Ave., Gaithersburg, 

MD. 

Contact Person: Margaret McCabeJanicki, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 1535, Silver Spring, 

MD 20993, 301–796–7029, 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 April 27, 2011, the 

committee will discuss, make 

recommendations, and vote on 

information related to the premarket 

approval application supplement for 

RESTYLANE, sponsored by Medicis 

Aesthetics, Inc. RESTYLANE is 

currently approved for mid- to deepdermal implantation for the correction 

of moderate to severe facial wrinkles 

and folds, such as nasolabial folds. The 

sponsor is requesting an expanded 

indication, to include use of 

RESTYLANE for augmentation of the 

lips. 

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: 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 19, 2011. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 p.m. on the meeting day. 

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 


jlentini on DSKJ8SOYB1PROD with NOTICES