60856 Federal Register / Vol. 79, No. 195 / Wednesday, October 8, 2014 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0001] 

Drug Safety and Risk Management 

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: Drug Safety and 

Risk Management (DSaRM) 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 18, 2014, from 9 a.m. 

to 4 p.m. 

Location: FDA White Oak Campus, 

10903 New Hampshire Ave., Building 

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: Kristina Toliver, 

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: DSaRM@

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: The committee will discuss 

the Food and Drug Administration 

Amendments Act of 2007 which 

requires FDA to bring, at least annually, 

one or more drugs with Risk Evaluation 

and Mitigation Strategies (REMS) with 

elements to assure safe use (ETASU) 

before the DSaRM Advisory Committee. 

The Agency plans to discuss the risk 

management of eculizumab (SOLIRIS). 

The Agency will seek public input 

whether the REMS with ETASU for this 

drug assures safe use of the drug, is not 

unduly burdensome on patient access to 

the drug, and to the extent practicable, 

minimizes the burden on the health care 

delivery system. 

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 November 3, 2014. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. and 2 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 

24, 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 27, 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 Kristina 

Toliver 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: October 2, 2014. 

Jill Hartzler Warner, 

Associate Commissioner for Special Medical 

Programs. 

[FR Doc. 2014–24002 Filed 10–7–14; 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 Board to the Food and Drug 

Administration 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: Science Board to 

the Food and Drug Administration 

(Science Board). 

General Function of the Committee: 

The Science Board provides advice 

primarily to the Commissioner of Food 

and Drugs and other appropriate 

officials on specific complex scientific 

and technical issues important to the 

FDA and its mission, including 

emerging issues within the scientific 

community. Additionally, the Science 

Board provides advice to the Agency on 

keeping pace with technical and 

scientific developments including in 

regulatory science, input into the 

Agency’s research agenda, and advice 

on upgrading its scientific and research 

facilities and training opportunities. It 

will also provide, where requested, 

expert review of Agency sponsored 

intramural and extramural scientific 

research programs. 

Date and Time: The meeting will be 

held on Wednesday, November 19, 

2014, from approximately 8:30 a.m. to 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 195 / Wednesday, October 8, 2014 / Notices 60857 

5:30 p.m., and Thursday, November 20, 

2014, from approximately 8:30 a.m. to 

12:45 p.m. 

Location: FDA White Oak Campus, 

10903 New Hampshire Ave., Building 

31 Conference Center, the Great Room 

(Rm. 1503), Sections B and C, Silver 

Spring, Maryland 20993. For those 

unable to attend in person, the meeting 

will also be Web cast. The link for the 

Web cast is available at https://

collaboration.fda.gov/scienceboard. 

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: Martha Monser, 

Office of the Chief Scientist, Office of 

the Commissioner, Food and Drug 

Administration, Bldg. 32, Rm. 4286, 

10903 New Hampshire Ave., Silver 

Spring, Maryland 20993, 301–796–4627, 

martha.monser@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: On November 19, 2014, the 

Science Board will review the existing 

nonclinical and clinical data related to 

the use and potential toxicity of 

anesthetics and sedation drugs in the 

pediatric population. The Science Board 

will be asked to make recommendations 

on steps the FDA should take to further 

evaluate and to mitigate the risks 

associated with the use of these drugs in 

the pediatric population and 

mechanisms to best communicate with 

the public regarding this issue. 

On November 20, 2014, the Science 

Board will be provided with progress 

reports from two subcommittees, the 

Commissioner’s Fellowship Program 

Evaluation subcommittee and the 

Science Moving Forward subcommittee. 

The Board will be asked to support the 

formation of a new subcommittee to 

evaluate the Office of Regulatory Affairs’ 

current investments in the Food 

Emergency Response Network 

cooperative agreement program and 

funding for state laboratories to achieve 

International Organization for 

Standardization accreditation. The 

Board will also be asked to support the 

formation of a new subcommittee to 

evaluate the Centers of Excellence in 

Regulatory Science and Innovation 

program. A recipient of one of the fiscal 

year 2013 Scientific Achievement 

Awards (selected by the Board) will 

provide an overview of the activities for 

which the award was given. 

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 pertaining to issues before 

the Board on November 19, 2014, may 

be made to the contact person on or 

before Wednesday, November 12, 2014. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. and 2 p.m. on November 19, 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 Tuesday, November 4, 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 at the 

November 19, 2014, meeting by 

Wednesday, November 5, 2014. 

Written submissions pertaining to 

issues before the Board on November 

20, 2014, may be made to the contact 

person on or before Thursday, 

November 13, 2014. Oral presentations 

from the public will be scheduled 

between approximately 12 p.m. and 

12:30 p.m. on November 20, 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 Wednesday, November 5, 

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 at the November 20, 

2014, meeting by Thursday, November 

6, 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 Martha 

Monser 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: October 2, 2014. 

Jill Hartzler Warner, 

Associate Commissioner for Special Medical 

Programs. 

[FR Doc. 2014–24001 Filed 10–7–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0967] 

Prescription Drug User Fee Act 

Patient-Focused Drug Development; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES