6732 Federal Register / Vol. 80, No. 25 / Friday, February 6, 2015 / Notices 

DATES: Pharmaceutical companies may 

submit proposed agendas to the Agency 

by April 7, 2015. 

FOR FURTHER INFORMATION CONTACT: Dan 

Brum, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 5480, Silver Spring, 

MD 20993–0002, 301–796–0578, 

dan.brum@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

An important part of CDER’s 

commitment to make safe and effective 

drugs available to all Americans is 

optimizing the efficiency and quality of 

the drug review process. To support this 

primary goal, CDER has initiated 

various training and development 

programs to promote high performance 

in its regulatory project management 

staff. CDER seeks to significantly 

enhance review efficiency and review 

quality by providing the staff with a 

better understanding of the 

pharmaceutical industry and its 

operations. To this end, CDER is 

continuing its training program to give 

regulatory project managers the 

opportunity to tour pharmaceutical 

facilities. The goals are to provide the 

following: (1) Firsthand exposure to 

industry’s drug development processes, 

and (2) a venue for sharing information 

about project management procedures 

(but not drug-specific information) with 

industry representatives. 

II. The Site Tours Program 

In this program, over a 2- to 3-day 

period, small groups (five or less) of 

regulatory project managers, including a 

senior level regulatory project manager, 

can observe operations of 

pharmaceutical manufacturing and/or 

packaging facilities, pathology/

toxicology laboratories, and regulatory 

affairs operations. Neither this tour nor 

any part of the program is intended as 

a mechanism to inspect, assess, judge, 

or perform a regulatory function, but is 

meant rather to improve mutual 

understanding and to provide an avenue 

for open dialogue. During the Site Tours 

Program, regulatory project managers 

will also participate in daily workshops 

with their industry counterparts, 

focusing on selective regulatory issues 

important to both CDER staff and 

industry. The primary objective of the 

daily workshops is to learn about the 

team approach to drug development, 

including drug discovery, preclinical 

evaluation, tracking mechanisms, and 

regulatory submission operations. The 

overall benefit to regulatory project 

managers will be exposure to project 

management, team techniques, and 

processes employed by the 

pharmaceutical industry. By 

participating in this program, the 

regulatory project manager will grow 

professionally by gaining a better 

understanding of industry processes and 

procedures. 

III. Site Selection 

All travel expenses associated with 

the Site Tours Program will be the 

responsibility of CDER; therefore, 

selection will be based on the 

availability of funds and resources for 

each fiscal year. Selection will also be 

based on firms having a favorable 

facility status as determined by FDA’s 

Office of Regulatory Affairs District 

Offices in the firms’ respective regions. 

Firms interested in offering a site tour 

or learning more about this training 

opportunity should respond by 

submitting a proposed agenda to Dan 

Brum (see DATES and FOR FURTHER

INFORMATION CONTACT). 

Dated: February 2, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–02426 Filed 2–5–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects (Section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995), the 

Health Resources and Services 

Administration (HRSA) announces 

plans to submit an Information 

Collection Request (ICR), described 

below, to the Office of Management and 

Budget (OMB). Prior to submitting the 

ICR to OMB, HRSA seeks comments 

from the public regarding the burden 

estimate, below, or any other aspect of 

the ICR. 

DATES: Comments on this Information 

Collection Request must be received no 

later than April 7, 2015. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 10C–03, Parklawn 

Building, 5600 Fishers Lane, Rockville, 

MD 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call the HRSA Information Collection 

Clearance Officer at (301) 443–1984. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

information request collection title for 

reference. 

Information Collection Request Title: 

Nurse Corps Scholarship Program, OMB 

No. 0915–0301—Revision. 

Abstract: The Nurse Corps 

Scholarship Program (Nurse Corps SP) 

is a competitive Federal program, which 

awards scholarships to individuals for 

attendance at accredited schools of 

nursing. The Bureau of Health 

Workforce (BHW) in HRSA administers 

the program. The scholarship consists of 

payment of tuition, fees, other 

reasonable educational costs, and a 

monthly support stipend. In return, the 

students agree to provide a minimum of 

2 years of full-time clinical service (or 

an equivalent part-time commitment, as 

approved by the Nurse Corps SP) at a 

health care facility with a critical 

shortage of nurses as defined by the 

program. Nurse Corps SP recipients 

must be willing to (and are required to) 

fulfill their Nurse Corps SP service 

commitment at a health care facility 

with a critical shortage of nurses in the 

United States, which includes, in 

addition to the several states, only: The 

District of Columbia, Guam, the 

Commonwealth of Puerto Rico, the 

Northern Mariana Islands, the U.S. 

Virgin Islands, American Samoa, the 

Federated States of Micronesia, the 

Republic of the Marshall Islands, and 

the Republic of Palau. 

Students who are uncertain of their 

commitment to provide nursing care in 

a health care facility with a critical 

shortage of nurses in the United States 

or these territories are advised not to 

participate in the program. 

Need and Proposed Use of the 

Information: The Nurse Corps 

Scholarship Program needs to collect 

data to determine an applicant’s 

eligibility for the program, to monitor a 

participant’s continued enrollment in a 

school of nursing, to monitor the 

participant’s compliance with the Nurse 

Corps Scholarship Program service 

obligation, and to obtain data on its 

program to ensure compliance with 

statutory mandates and prepare annual 

reports to Congress. The following 

information will be collected: (1) From 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 25 / Friday, February 6, 2015 / Notices 6733 

the applicants and/or the schools— 

general applicant and nursing school 

data such as full name, location, tuition/ 

fees, and enrollment status; (2) from the 

schools, on an annual basis—data 

concerning tuition/fees and student 

enrollment status; and (3) from the 

participants and their health care 

facilities with a critical shortage of 

nurses, on a biannual basis—data 

concerning the participant’s 

employment status, work schedule and 

leave usage. BHW enters the cost 

information into its data system, along 

with the projected amount for the 

monthly stipend, to determine the 

amount of each scholarship award. 

Likely Respondents: Nurse Corps 

Scholarship Program scholars in school 

and graduates. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install and utilize 

technology and systems for the purpose 

of collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this Information 

Collection Request are summarized in 

the table below. 

Total Estimated Annualized burden 

hours: 

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Eligible Applications ............................................................. 2,600 1 2,600 2 5,200 

In-School Monitoring ............................................................ 500 2 1,000 2 2,000 

In-Service Monitoring ........................................................... 500 2 1,000 1 1,000 

Total .............................................................................. 3,600 ........................ 4,600 ........................ 8,200 

HRSA specifically requests comments 

on (1) the necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions, (2) the accuracy of the 

estimated burden, (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and (4) the 

use of automated collection techniques 

or other forms of information 

technology to minimize the information 

collection burden. 

Jackie Painter, 

Director, Division of the Executive Secretariat. 

[FR Doc. 2015–02314 Filed 2–5–15; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of Dietary Supplements 2015– 

2020 Strategic Plan Request for 

Comments 

SUMMARY: The Office of Dietary 

Supplements (ODS) at the National 

Institutes of Health (NIH) has initiated 

a strategic planning process that will 

culminate in the ODS Strategic Plan for 

2015–2020. To assist with this process, 

the ODS requests input from research 

communities—academic, government, 

and industry—and from other interested 

parties. 

DATES: In order to ensure full 

consideration, all responses must be 

submitted by midnight, March 6, 2015. 

ADDRESSES: Interested individuals and 

organizations should submit their 

responses to ODSplan@od.nih.gov. 

FOR FURTHER INFORMATION CONTACT: 

Anne L. Thurn, Ph.D., Office of Dietary 

Supplements, National Institutes of 

Health, 6100 Executive Boulevard, 

Room 3B01, Bethesda, MD 20892–7517, 

Phone: 301–435–2920, Fax: 301–480– 

1845, Email: ODSplan@od.nih.gov. 

SUPPLEMENTARY INFORMATION: The 

overall purpose of the strategic planning 

effort is to identify both new 

opportunities and emerging needs for 

incorporation in the programmatic 

efforts of the Office. A background 

paper, ODS Strategic Plan 2010–2014 

Progress Report, summarizes progress in 

five key areas of ODS activities. The 

background paper and related 

information are available on the ODS 

Web site at http://ods.od.nih.gov/

strategicplan. 

Guidance is being requested from all 

interested parties on these important 

issues. 

• Are the current strategic goals 

adequate? 

• Is ODS meeting its stakeholders’ 

needs? 

• In the future, should some of ODS’s 

current programs or activities be given 

higher (or lower) priority? 

• How can ODS more effectively 

provide useful information to the ODS 

user community, including consumers, 

investigators, practitioners, industry, 

media, policy makers, government, and 

other interested parties? 

Dated: January 30, 2015. 

Lawrence A. Tabak, 

Deputy Director, National Institutes of Health. 

[FR Doc. 2015–02370 Filed 2–5–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[USCG–2014–0973; OMB Control Number 

1625–0077] 

Collection of Information Under 

Review by Office of Management and 

Budget 

AGENCY: Coast Guard, DHS. 

ACTION: Thirty-day notice requesting 

comments. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995 the 

U.S. Coast Guard is forwarding 

Information Collection Requests (ICRs), 

abstracted below, to the Office of 

Management and Budget (OMB), Office 

of Information and Regulatory Affairs 

(OIRA), requesting approval of an 

extension of a currently approved 

collection of information: 1625–0077, 

Security Plans for Ports, Vessels, 

Facilities, Outer Continental Shelf 

Facilities and Other Security-Related 

Requirements. Review and comments by 

OIRA ensure we only impose paperwork 

burdens commensurate with our 

performance of duties. 

DATES: Comments must reach the Coast 

Guard and OIRA on or before April 7, 

2015. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES