61082 Federal Register / Vol. 79, No. 196 / Thursday, October 9, 2014 / Notices 

IV. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

this guidance have been approved under 

OMB control numbers 0910–0284 and 

0910–0645. 

V. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

VI. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at either 

http://www.fda.gov/AnimalVeterinary/

GuidanceComplianceEnforcement/

GuidanceforIndustry/default.htm or 

http://www.regulations.gov. 

Dated: October 6, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–24152 Filed 10–8–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0001] 

Science Advisory Board to the 

National Center for Toxicological 

Research 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: Science 

Advisory Board (SAB) to the National 

Center for Toxicological Research 

(NCTR). 

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 November 6, 2014, from 8:15 

a.m. to 4:15 p.m. and on November 7, 

2014, from 8 a.m. to 2 p.m. 

Location: NCTR SAB, 3900 NCTR Rd., 

Conference Room B–12, Jefferson, AR 

72079. 

Contact Person: Donna Mendrick, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 32, rm. 

2208, Silver Spring, MD 20993–0002, 

301–796–8892, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). 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 at http://www.fda.

gov/AdvisoryCommittees/default.htm 

and scroll down to the appropriate 

advisory committee meeting link, or call 

the advisory committee information line 

to learn about possible modifications 

before coming to the meeting. 

Agenda: On November 6, 2014, the 

NCTR Director will welcome the 

participants and provide a Center-wide 

update on scientific initiatives and 

accomplishments during the past year. 

The SAB will be presented with an 

overview of the Division of 

Microbiology Subcommittee and the 

Subcommittee Site Visit Report. 

Following the public session, the SAB 

will hear an update from each of 

NCTR’s research Divisions, the Office of 

Science Coordination, followed by an 

update on NCTR’s Global Interactions. 

On November 7, 2014, the Office of 

the Chief Scientist will update the SAB 

on their research needs, and discuss 

opportunities for collaboration to help 

address these needs, followed by a 

report from the National Toxicology 

Program of the National Institutes of 

Environmental Health Sciences on 

current and future collaboration. 

The Center for Biological Evaluation 

and Research, the Center for Drug 

Evaluation and Research, the Center for 

Devices and Radiological Health, the 

Center for Veterinary Medicine, the 

Center for Tobacco Products, the Office 

of Regulatory Affairs, and the Center for 

Food Safety and Applied Nutrition will 

each briefly discuss their Center-specific 

research strategic needs. 

Following an open discussion of all 

the information presented, the open 

session of the meeting will close so that 

SAB members can discuss personnel 

issues at NCTR. 

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 meeting 

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 October 30, 2014. 

Oral presentations from the public will 

be scheduled between approximately 12 

noon to 1 p.m. on November 6, 2014. 

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 October 22, 2014. 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 

October 23, 2014. 

Closed Committee Deliberations: On 

November 7, 2014, from 12 noon to 2 

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)). This portion of the meeting 

will be closed to permit discussion of 

information concerning individuals 

associated with the research programs at 

NCTR. 

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 Donna 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 79, No. 196 / Thursday, October 9, 2014 / Notices 61083 

Mendrick 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). 

Date: September 30, 2014. 

Jill Hartzler Warner, 

Associate Commissioner for Special Medical 

Programs. 

[FR Doc. 2014–24039 Filed 10–8–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0001] 

Oncologic 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: Oncologic 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 November 6, 2014, from 8 a.m. 

to 5 p.m. 

Location: FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503), 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 ‘‘Public Meetings at the FDA White 

Oak Campus.’’ Please note that visitors 

to the White Oak Campus must enter 

through Building 1. 

Contact Person: Caleb Briggs, 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, email: 

ODAC@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). 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 at http://

www.fda.gov/AdvisoryCommittees/

default.htm and scroll down to the 

appropriate advisory committee meeting 

link, or call the advisory committee 

information line to learn about possible 

modifications before coming to the 

meeting. 

Agenda: During the morning session, 

the committee will discuss new drug 

application (NDA) 205353, panobinostat 

capsules, application submitted by 

Novartis Pharmaceuticals Corporation. 

The proposed indication (use) for this 

product is in combination with 

bortezomib and dexamethasone, for the 

treatment of patients with multiple 

myeloma who have received at least one 

prior therapy. 

During the afternoon session, the 

committee will discuss NDA 206317, 

ferric pyrophosphate solution, for 

administration via hemodialysis 

dialysate, application submitted by 

Rockwell Medical, Inc. The proposed 

indications (uses) for this product are 

for the treatment of iron loss or iron 

deficiency to maintain hemoglobin in 

adult patients with hemodialysisdependent stage 5 chronic kidney 

disease and to reduce the prescribed 

dose of erythropoiesis stimulating agent 

required to maintain desired 

hemoglobin levels. 

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 meeting 

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 October 23, 2014. 

Oral presentations from the public will 

be scheduled between approximately 

10:30 a.m. to 11 a.m., and 3:30 p.m. to 

4 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 October 15, 2014. 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 

October 16, 2014. 

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 Caleb Briggs 

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). 

September 30, 2014. 

Jill Hartzler Warner, 

Associate Commissioner for Special Medical 

Programs. 

[FR Doc. 2014–24038 Filed 10–8–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0394] 

Request for Nominations for Voting 

Members on a Public Advisory 

Committee; Tobacco Products 

Scientific Advisory Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

mstockstill on DSK4VPTVN1PROD with NOTICES