Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Notices 73327 

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 

biologics license application (BLA) 

125553 for EP2006, a proposed 

biosimilar to Amgen Inc.’s NEUPOGEN 

(filgrastim), submitted by Sandoz, Inc. 

The proposed indications (uses) for this 

product are: (1) To decrease the 

incidence of infection, as manifested by 

febrile neutropenia, in patients with 

nonmyeloid malignancies receiving 

myelosuppressive anti-cancer drugs 

associated with a significant incidence 

of severe neutropenia with fever; (2) for 

reducing the time to neutrophil recovery 

and the duration of fever, following 

induction or consolidation 

chemotherapy treatment of adults with 

acute myeloid leukemia; (3) to reduce 

the duration of neutropenia and 

neutropenia-related clinical sequelae, 

e.g., febrile neutropenia in patients with 

nonmyeloid malignancies undergoing 

myeloablative chemotherapy followed 

by marrow transplantation; (4) for the 

mobilization of hematopoietic 

progenitor cells into the peripheral 

blood for collection by leukapheresis; 

and (5) for chronic administration to 

reduce the incidence and duration of 

sequelae of neutropenia (e.g., fever, 

infections, oropharyngeal ulcers) in 

symptomatic patients with congenital 

neutropenia, cyclic neutropenia, or 

idiopathic neutropenia. 

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 December 22, 2014. 

Oral presentations from the public will 

be scheduled between approximately 

2:15 p.m. to 3:15 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 

December 12, 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 December 15, 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). 

Dated: December 3, 2014. 

Jill Hartzler Warner, 

Associate Commissioner for Special Medical 

Programs. 

[FR Doc. 2014–28847 Filed 12–8–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–2032] 

Request for Nominations for Voting 

Members on the Food Advisory 

Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting 

nominations for voting members to 

serve on the Food Advisory Committee, 

Office of Regulations, Policy, and Social 

Sciences, Center for Food Safety and 

Applied Nutrition. FDA seeks to include 

the views of women and men, members 

of all racial and ethnic groups, and 

individuals with and without 

disabilities on its advisory committees 

and, therefore, encourages nominations 

of appropriately qualified candidates 

from these groups. 

DATES: Nominations received on or 

before January 30, 2015, will be given 

first consideration for membership on 

the Food Advisory Committee. 

Nominations received after January 30, 

2015, will be considered for nomination 

to the committee as later vacancies 

occur. 

ADDRESSES: All nominations for 

membership should be submitted 

electronically by logging into the FDA 

Advisory Committee Membership 

Nomination Portal: https://

www.accessdata.fda.gov/scripts/

FACTRSPortal/FACTRS/index.cfm, by 

mail to Advisory Committee Oversight 

and Management Staff, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5103, Silver Spring, 

MD 20993–0002, or by FAX to 301–847– 

8640. 

Information about becoming a 

member on an FDA advisory committee 

can also be obtained by visiting FDA’s 

Web site at http://www.fda.gov/

AdvisoryCommittees/default.htm. 

FOR FURTHER INFORMATION: Regarding all 

nominations questions for membership, 

the primary contact is: Karen Strambler, 

Office of Regulations, Policy, and Social 

Sciences, Center for Food Safety and 

Applied Nutrition, 5100 Paint Branch 

Pkwy., Rm. 1C–016, College Park, MD 

20740, 240–402–2589, FAX: 301–436– 

2637, FoodAdvisoryCommittee@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

requesting nominations for voting 

members on the Food Advisory 

Committee. 

I. General Description of the Committee 

Duties 

The Food Advisory Committee 

provides advice to the Commissioner of 

Food and Drugs and other appropriate 

officials on emerging food safety, food 

science, nutrition, and other foodrelated health issues that FDA considers 

of primary importance for its food and 

cosmetics programs. The Committee 

may be charged with reviewing and 

evaluating available data and making 

recommendations on matters such as 

those relating to: (1) Broad scientific and 

technical food- or cosmetic-related 

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73328 Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Notices 

issues; (2) the safety of food ingredients 

and new foods; (3) labeling of foods and 

cosmetics; (4) nutrient needs and 

nutritional adequacy; and (5) safe 

exposure limits for food contaminants. 

The Committee may also be asked to 

provide advice and make 

recommendations on ways of 

communicating to the public the 

potential risks associated with these 

issues and on approaches that might be 

considered for addressing the issues. 

II. Criteria for Voting Members 

The Committee consists of a core of 

15 voting members including the Chair. 

Members and the Chair are selected by 

the Commissioner or designee from 

among individuals knowledgeable in 

the fields of food science, microbiology, 

epidemiology, pediatric immunology, 

nutrition, food technology, 

biochemistry, and environmental 

health. Members are invited to serve for 

overlapping terms of up to 4 years. 

Almost all non-Federal members of 

this committee serve as Special 

Government Employees. Of the 15 

members who vote, 2 are technically 

qualified members identified with 

consumer interests. In addition to the 

voting members, the Committee has two 

nonvoting members who are identified 

with industry interests. 

III. Nomination Procedures 

Any interested person may nominate 

one or more qualified individuals for 

membership on the Committee. Selfnominations are also accepted. 

Nominations must include a current 

re ́sume ́ or curriculum vitae for each 

nominee, including a current business 

address and/or home address, telephone 

number, and email address if available. 

Nominations must also specify the 

advisory committee for which the 

nominee is recommended. Nominations 

must also acknowledge that the 

nominee is aware of the nomination 

unless self-nominated. FDA will ask 

potential candidates to provide detailed 

information concerning such matters as 

financial holdings, employment, 

research grants, and/or contracts to 

permit evaluation of possible sources of 

conflicts of interest. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: December 5, 2014. 

Jill Hartzler Warner, 

Associate Commissioner for Special Medical 

Programs. 

[FR Doc. 2014–28889 Filed 12–9–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

[Docket No. DHS–2014–0005] 

PRA Extension: 1670–0023 Technical 

Assistance Request and Evaluation 

AGENCY: National Protection and 

Programs Directorate, DHS. 

ACTION: 60-day notice and request for 

comments; reinstatement of a previously 

approved collection: 1670–0023. 

SUMMARY: The Department of Homeland 

Security (DHS), National Protection and 

Programs Directorate (NPPD), Office of 

Cybersecurity and Communications 

(CS&C), Office of Emergency 

Communications, (OEC) will submit the 

following Information Collection 

Request to the Office of Management 

and Budget (OMB) for review and 

clearance in accordance with the 

Paperwork Reduction Act of 1995 (Pub. 

L. 104–13, 44 U.S.C. Chapter 35). 

DATES: Comments are encouraged and 

will be accepted until February 9, 2015. 

This process is conducted in accordance 

with 5 CFR 1320.1. 

ADDRESSES: Written comments and 

questions about this Information 

Collection Request should be forwarded 

to DHS/NPPD/CS&C/OEC, 245 Murray 

Lane SW., Mail Stop 0640, 

Arlington,VA 20598–0640. Emailed 

requests should go to Kendall Carpenter, 

Kendall.Carpenter@hq.dhs.gov. Written 

comments should reach the contact 

person listed no later than February 9, 

2015. Comments must be identified by 

‘‘DHS–2014–0005’’and may be 

submitted by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov . 

• Email: Kendall.Carpenter@

hq.dhs.gov 

Æ Include the docket number in the 

subject line of the message. 

Instructions: All submissions received 

must include the words ‘‘Department of 

Homeland Security’’ and the docket 

number for this action. Comments 

received will be posted without 

alteration at http://www.regulations.gov, 

including any personal information 

provided. 

SUPPLEMENTARY INFORMATION: OEC 

formed under Title XVIII of the 

Homeland Security Act of 2002, 6 

U.S.C.574 et seq., as amended, is 

authorized to provide technical 

assistance at no charge to State, 

regional, local, and tribal government 

officials. OEC will use the Technical 

Assistance Request Form to identify the 

number and type of technical assistance 

requests from each State and territory. 

OEC will use the Technical Assistance 

Evaluation Form to support quality 

improvement of its technical assistance 

services. Both Forms may be submitted 

electronically or in paper form. 

OMB is particularly interested in 

comments that: 

1. Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

2. Evaluate the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

3. Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

4. Minimize the burden of the 

collection of information on those who 

are to respond, including through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submissions 

of responses. 

Analysis 

Agency: Department of Homeland 

Security, National Protection and 

Programs Directorate, Office of 

Emergency Communications. 

Title: Technical Asistance Request 

and Evaluation. 

OMB Number: 1670–0023. 

Frequency: Annually. 

Affected Public: State, local and tribal 

government. 

Number of Respondents: 56 

respondents (estimate). 

Estimated Time per Respondent: 15 

minutes. 

Total Burden Hours: 175 annual 

burden hours. 

Total Burden Cost (capital/startup): 

$0. 

Total Recordkeeping Burden: $0. 

Total Burden Cost (operating/

maintaining): $4,273.50. 

Dated: December 2, 2014. 

Scott Libby, 

Deputy Chief Information Officer, National 

Protection and Programs Directorate, 

Department of Homeland Security. 

[FR Doc. 2014–28885 Filed 12–9–14; 8:45 am] 

BILLING CODE 9110–9P–P 

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