65670 Federal Register / Vol. 79, No. 214 / Wednesday, November 5, 2014 / Notices 

12. On page 47646, in the first 

column, in the Response to Comment 

21, in the first sentence of the response, 

delete ‘‘from the coverage of part 114’’ 

and, at the end of the first sentence of 

the response, insert ‘‘or that do not 

otherwise meet the definitions of 

acidified food.’’ 

13. On page 47646, in the first 

column, in the Response to Comment 

22, replace the response with the 

following: ‘‘FDA does not agree that the 

‘Food Product Group’ categories in any 

way indicates FDA’s thinking as to 

whether all fruit and vegetable juices are 

acidified foods and are therefore subject 

to the acidified foods regulations in 

parts 108 and 114. Rather, the ‘Food 

Product Group’ categories are designed 

to help FDA understand the nature of 

products. For more information on what 

constitutes an acidified food, we 

recommend manufacturers consult the 

definition of acidified foods in 

§ 114.3(b).’’ 

14. On page 47646, in the second 

column, in the Response to Comment 

24, replace the second paragraph of the 

response with the following: ‘‘When 

optional information about the ‘Food 

Product Group’ category is provided, we 

will use it to help us understand the 

nature of the products and to help us 

prioritize which facilities to inspect.’’ 

Dated: October 30, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–26238 Filed 11–4–14; 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: Pediatric 

Oncology Subcommittee of the 

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 December 11, 2014, from 8 a.m. 

to 3:30 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: 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: Information will be 

presented to gauge investigator interest 

in exploring potential pediatric 

development plans for three products in 

various stages of development for adult 

cancer indications. The subcommittee 

will consider and discuss issues 

concerning diseases to be studied, 

patient populations to be included, and 

possible study designs in the 

development of these products for 

pediatric use. The discussion will also 

provide information to the Agency 

pertinent to the formulation of written 

requests for pediatric studies, if 

appropriate. The products under 

consideration are: (1) GANETESPIB, 

application submitted by Synta 

Pharmaceuticals Corp. (2) Etirinotecan, 

application submitted by Nektar 

Therapeutics, and (3) RO5503781, 

application submitted by Hoffmann-La 

Roche, Inc. 

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 3, 2014. 

Oral presentations from the public will 

be scheduled between approximately 

8:55 a.m. to 9:15 a.m., 11:10 a.m. to 

11:30 a.m., and 2:10 p.m. to 2:30 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 November 25, 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 

November 26, 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). 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 79, No. 214 / Wednesday, November 5, 2014 / Notices 65671 

Dated: October 30, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–26237 Filed 11–4–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Centers for Disease Control and 

Prevention (CDC)/Health Resources 

and Services Administration (HRSA) 

Advisory Committee on HIV, Viral 

Hepatitis, and Sexually Transmitted 

Disease (STD) Prevention and 

Treatment 

AGENCY: Health Resources and Services 

Administration (HRSA), HHS. 

ACTION: Notice; correction. 

SUMMARY: The Health Resources and 

Services Administration published a 

notice in the Federal Register, FR 2014– 

25199 (October 23, 2014), announcing 

the meeting for the Centers for Disease 

Control and Prevention (CDC)/Health 

Resources and Services Administration 

(HRSA) Advisory Committee on HIV, 

Viral Hepatitis and STD Prevention and 

Treatment. The action is to provide 

correction to the virtual meeting audio 

access code. 

Correction: In the Federal Register, 

FR 2014–25199 (October 23, 2014), 

please make the following corrections: 

Join the meeting by: 

1. (Audio Portion) Calling the Toll free 

Phone Number 1–888–942–8515 and 

providing the Participant Pass Code 

9582370, and 

2. (Visual Portion) Connecting to the 

Advisory Committee Adobe Connect Pro 

Meeting using the following URL: 

https://hrsa.connectsolutions.com/

cdchrsa_advcmt/. 

Dated: October 29, 2014. 

Jackie Painter, 

Acting Director, Division of Policy and 

Information Coordination. 

[FR Doc. 2014–26225 Filed 11–4–14; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Organization, Functions, and 

Delegations of Authority 

Part G 

Indian Health Service 

Part G, of the Statement of 

Organization, Functions, and 

Delegations of Authority of the 

Department of Health and Human 

Services (HHS), as amended at 70 FR 

60350, October 17, 2005, and most 

recently as amended at 75 FR 38112, 

July 1, 2010 is hereby amended to 

establish an Office of Human Resources 

(OHR) and transfer the functions and 

staff from the Program Integrity and 

Ethics Staff (renamed as Division of 

Personnel Security and Ethics), Division 

of Commissioned Personnel Support, 

and Division of Human Resources, from 

the Office of Management Services and 

the Division of Health Professions 

Support, from the Office of Public 

Health Support to the Office of Human 

Resources within the IHS Headquarters 

(HQ) organizational structure. The OHR 

will ensure a competent work force 

appropriately assigned to carry out the 

IHS mission. The changes will relocate 

major human resources (HR) 

components within a single 

organization that reports to the Director, 

IHS. The Office will provide leadership 

and accountability of Agency personnel 

requirements, recruitment and 

retention, management, and training 

and development objectives and 

activities to support the Agency’s 

mission. 

Office of Human Resources (OHR) 

(GAN) 

(1) Advises the Director, IRS, on HR 

goals, objectives, policies, and priorities 

of the Agency and the HR profession; (2) 

provides leadership, direction, and 

oversight of Agency-wide HR activities 

that support the IHS organization and 

programs; (3) develops and maintains 

strategic and operational HR plans to 

ensure a current and future work force 

for management, program delivery, and 

administrative support systems; (4) 

furthers the Agency’s Indian Preference 

by ensuring compliance with Indian 

Preference statutory and policy 

requirements; (5) develops, 

promulgates, and administers Agency 

HR guidelines, and instructions in 

accordance with Office of Personnel 

Management (OPM), HHS, Public 

Health Service policies and the Indian 

Health Care Improvement Act (IHCIA), 

as amended; (6) ensures consistency in 

recruitment, training, and development 

applications, approaches, and outcomes 

by administering an Agency-wide HR 

system of functional responsibility, 

authority, and accountability; (7) issues 

standards to monitor and evaluate all 

IRS training and development activities 

and ensures that expenditures for 

recruitment, training, and development 

support the Agency’s mission and goals; 

(8) provides Agency-wide policy 

guidance, consultation, and technical 

assistance on all IHS HR management, 

recruitment, and retention activities; (9) 

manages Agency work force information 

and conducts analyses, including trends 

analysis and forecasting necessary for 

Agency HR planning, management, and 

evaluation; (10) administers an Agencywide information clearinghouse on HR 

recruitment, training, and development 

that serves all IHS organizations and 

Tribal health programs; (11) directs the 

Agency-wide scholarship, loan 

repayment, professional recruitment 

and retention, training, and 

development systems; (12) administers 

personnel management operations and 

services for HQ organizational units; 

(13) ensures a safe, healthy, and 

productive work environment for IHS 

personnel to carry out their assigned 

duties and responsibilities, and that HR 

factors are part of the Agency’s decision 

making processes; (14) establishes and 

maintains liaison and coordination with 

a variety of public and private 

organizations to provide the IHS with 

up-to-date HR recruitment, 

management, training, retention and 

development technologies; (15) ensures 

that organization and program changes 

involve assessments of appropriate HR 

requirements, including work design, 

knowledge, skills, abilities, and work 

load; (16) prepares reports and studies 

reflecting IHS HR activities in response 

to the Congress, other Federal agencies, 

and Tribal Governments; and (17) 

participates in cross-cutting issues and 

processes, including, but not limited to 

emergency preparedness/security, 

budget formulation, self-determination 

issues, Tribal shares computations and 

resolution of audit findings as may be 

needed and appropriate. 

Division of Personnel Security and 

Ethics (DPSE) (GANA) 

(1) Advises the IHS Director and IHS 

management and supervisors of 

appropriate corrective and remedial 

actions to address or correct 

improprieties by Agency employees; (2) 

directs and provides leadership in the 

formulation of plans, guidance and 

evaluation of the IHS Personnel Security 

and Drug Testing Programs; (3) manages 

and directs the IHS ‘‘Ethics Program’’, 

mstockstill on DSK4VPTVN1PROD with NOTICES