Federal Register / Vol. 75, No. 233 / Monday, December 6, 2010 / Notices 75681 

Agenda: On February 9, 2011, the 

committee will discuss biologics license 

application (BLA) 125377, with the 

proposed trade name YERVOY 

(ipilimumab), submitted by BristolMyers Squibb Co. The proposed 

indication (use) for this product is for 

the treatment of advanced melanoma in 

patients who have received prior 

therapy. 

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 January 25, 2011. 

Oral presentations from the public will 

be scheduled between approximately 

10:30 a.m. to 11:30 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 January 14, 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 

January 18, 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 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 

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: December 1, 2010. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2010–30502 Filed 12–3–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Peripheral and Central Nervous 

System Drugs 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: Peripheral and 

Central Nervous System Drugs 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 January 20, 2011, from 8 a.m. 

to 5 p.m. and on January 21, 2011, from 

8 a.m. to 12 p.m. 

Location: FDA White Oak Campus, 

Building 31 Conference Center, the 

Great Room (rm. 1503), 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002. Information regarding 

special accommodations due to a 

disability, visitor parking and 

transportation may be accessed at: 

http://www.fda.gov/ 

AdvisoryCommittees/default.htm; under 

the heading ‘‘Resources for You’’, click 

on ‘‘White Oak Conference Center 

Parking and Transportation Information 

for FDA Advisory Committee Meetings’’. 

Please note that visitors to the White 

Oak Campus must have a valid driver’s 

license or other picture ID, and must 

enter through Building 1. 

Contact Person: Diem-Kieu Ngo, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 31, Rm. 2417, Silver Spring, 

MD 20993–0002, 301–796–9001, FAX 

301–847–8533, e-mail: 

diem.ngo@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512543. 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 January 20, 2011, the 

committee will discuss new drug 

application (NDA) 202–008, florbetapir 

F 18 injection, sponsored by Avid 

Radiopharmaceuticals, Inc., proposed 

for use in positron emission tomography 

(PET) imaging of b-amyloid (betaamyloid) aggregates in the brain to help 

rule out Alzheimer’s disease. 

On January 21, 2011, the committee 

will discuss NDA 201–277, gadobutrol 

injection, sponsored by Bayer 

HealthCare Pharmaceuticals, proposed 

for use in diagnostic magnetic resonance 

imaging (MRI) in adults and children (2 

years of age and older) to detect and 

visualize areas with disrupted blood 

brain barrier (BBB) and/or abnormal 

vascularity (abnormal blood supply and 

circulation) of the central nervous 

system. The BBB is an area consisting of 

specialized cells that restrict passage of 

certain molecules from the bloodstream 

into the brain. 

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 January 5, 2011. 


jdjones on DSK8KYBLC1PROD with NOTICES
75682 Federal Register / Vol. 75, No. 233 / Monday, December 6, 2010 / Notices 

Oral presentations from the public will 

be scheduled between approximately 

1:30 p.m. and 2:30 p.m. on January 20, 

2011, and between approximately 10 

a.m. and 11 a.m. on January 21, 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 December 27, 2010. 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 

December 28, 2010. 

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 Diem-Kieu 

Ngo 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: December 1, 2010. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2010–30501 Filed 12–3–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2000–N–0163; Formerly 

Docket No. 2000N–1219] 

Reclassification of Category IIIA 

Biological Products, Bacterial 

Vaccines and Related Biological 

Products; Implementation of Efficacy 

Review; Final Order; and Delmont 

Laboratories, Inc.: Denial of Request 

for a Hearing, and Revocation of 

License 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; final order. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing a final 

order pursuant to the reclassification 

procedures under the biologics 

regulations; denying the request by 

Delmont Laboratories, Inc. (Delmont), 

for a hearing on FDA’s proposal to 

revoke Delmont’s license based on the 

proposed reclassification of its product, 

Polyvalent Bacterial Antigens with ‘‘No 

U.S. Standard of Potency,’’ Staphage 

Lysate® (SPL) (hereinafter referred to as 

SPL) into Category II (unsafe, 

ineffective, or misbranded); and 

revoking Delmont’s U.S. License No. 

299. The final order finalizes the 

proposed order published in the Federal 

Register of May 15, 2000 (65 FR 31003) 

(May 2000 proposal), to reclassify 

Category IIIA bacterial vaccines and 

bacterial antigens into Category I or 

Category II. 

DATES: The final order reclassifying 

Delmont’s SPL into Category II, and 

Sanofi Pasteur Inc.’s (Sanofi’s) Tetanus 

Toxoid Adsorbed and Tetanus and 

Diphtheria Toxoids Adsorbed For Adult 

Use (DECAVACTM) into Category I for 

both primary immunization and booster 

use is effective December 6, 2010. The 

revocation of Delmont’s license (U.S. 

License No. 299) is effective December 

6, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, Suite 200N, Rockville, 

MD 20852–1448, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background on the Efficacy Review 

Process 

In the Federal Register of February 

13, 1973 (38 FR 4319), FDA issued 

procedures for the review by 

independent advisory panels of the 

safety, effectiveness, and labeling of 

biological products licensed before July 

1, 1972. These procedures were later 

codified in § 601.25 (21 CFR 601.25) (38 

FR 32048 at 32052, November 20, 1973). 

Under § 601.25, FDA assigned 

responsibility for the initial review of 

each of the biological product categories 

to a separate independent advisory 

panel consisting of qualified experts. 

Each panel was charged with preparing 

for the Commissioner of Food and Drugs 

an advisory report which was to: (1) 

Evaluate the safety and effectiveness of 

the biological products for which a 

license had been issued; (2) review their 

labeling; and (3) identify the biological 

products that are safe, effective, and not 

misbranded. Each advisory panel report 

was also to include recommendations 

classifying the products reviewed into 

one of three categories. 

• Category I, designating those 

biological products determined by the 

panel to be safe, effective, and not 

misbranded. 

• Category II, designating those 

biological products determined by the 

panel to be unsafe, ineffective, or 

misbranded. 

• Category III, designating those 

biological products determined by the 

panel not to fall within either Category 

I or Category II on the basis of the 

panel’s conclusion that the available 

data were insufficient to classify such 

biological products, and for which 

further testing was therefore required. 

Category III products were assigned to 

one of two subcategories. Category IIIA 

products were those that would be 

permitted to remain on the market 

pending the completion of further 

studies. Category IIIB products were 

those for which the panel recommended 

license revocation on the basis of the 

panel’s assessment of potential risks and 

benefits. 

In accordance with § 601.25, after 

reviewing the conclusions and 

recommendations of the review panels, 

FDA would publish in the Federal 

Register a proposed order containing: 

(1) A statement designating the 

biological products reviewed into 

Categories I, II, IIIA or IIIB; (2) a 

description of the testing necessary for 

Category IIIA biological products; and 

(3) the complete panel report. Under the 

proposed order, FDA would propose to 

revoke the licenses of those products 

designated into Category II and Category 

IIIB. After reviewing public comments, 

FDA would publish a final order on the 

matters covered in the proposed order. 

Two original advisory panels 

reviewed the four Category IIIA 

products that are the subject of this final 

order. The advisory panel for Bacterial 

Vaccines and Bacterial Antigens with 


jdjones on DSK8KYBLC1PROD with NOTICES