68806 Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Notices 

TABLE 3—SUMMARY OF OFF-SCHEDULE POSTMARKETING REQUIREMENTS—Continued 

[Numbers as of September 30, 2009] 

Off-schedule open PMRs NDA/ANDA 

(% of total PMR) 

BLA 

(% of total PMR) 1

Combined total ............................................................................................................................. 33 

(8.5%) 

8 

(9%) 

1See note 1 for table 1 of this document. 

TABLE 4—SUMMARY OF ON-SCHEDULE POSTMARKETING COMMITMENTS

[Numbers as of September 30, 2009] 

On-Schedule Open PMCs NDA/ANDA 

(% of total PMC) 

BLA 

(% of total PMC) 1

Pending ................................................................................................................................................ 449 (46%) 82 (25%) 

Ongoing ............................................................................................................................................... 147 (15%) 84 (26%) 

Submitted ............................................................................................................................................. 271 (28%) 78 (24%) 

Combined total ............................................................................................................................. 867 (89%) 244 (75%) 

1See note 1 for table 1 of this document. 

TABLE 5—SUMMARY OF OFF-SCHEDULE POSTMARKETING COMMITMENTS

[Numbers as of September 30, 2009] 

Off-Schedule Open PMCs NDA/ANDA 

(% of total PMC) 

BLA 

(% of total PMC) 1

Delayed ................................................................................................................................................ 100 (10%) 79 (24%) 

Terminated ........................................................................................................................................... 11 (1%) 2 (1%) 

Combined total ............................................................................................................................. 111 (11%) 81 (25%) 

1See note 1 for table 1 of this document. 

TABLE 6—SUMMARY OF CONCLUDED POSTMARKETING REQUIREMENTS AND COMMITMENTS

[October 1, 2008 to October 1, 2009] 

NDA/ANDA 

(% of total) 

BLA 

(% of total) 1

Concluded PMRs: 

Requirement met (fulfilled) ........................................................................................................... 28 (60%) 5 (56%) 

Requirement not met (released and new revised requirement issued) ....................................... 7 (15%) 2 (22%) 

Requirement no longer feasible or product withdrawn (released) ............................................... 12 (25%) 2 (22%) 

Total ....................................................................................................................................... 47 9 

Concluded PMCs: 

Commitment met (fulfilled) ........................................................................................................... 259 (79%) 32 (82%) 

Commitment not met (released and new revised requirement/commitment issued) .................. 21 (6%) 0 

Commitment no longer feasible or product withdrawn (released) ............................................... 48 (15%) 7 (18%) 

Total ....................................................................................................................................... 328 39 

1See note 1 for table 1 of this document. 

Dated: November 3, 2010. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2010–28193 Filed 11–8–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Statement of Organization, Functions 

and Delegations of Authority 

This notice amends Part R of the 

Statement of Organization, Functions 

and Delegations of Authority of the 

Department of Health and Human 

Services (HHS), Health Resources and 

Services Administration (HRSA) (60 FR 

56605, as amended November 6, 1995; 

as last amended at 75 FR 61157–61160 

dated October 4, 2010). 

This notice reflects organizational 

changes to the Health Resources and 

Services Administration. Specifically, 

this notice updates the Office of 

Information Technology (RB5) 

functional statement to better align 

functional responsibility, improve the 

management and delivery of 

information technology services, 

improve management and 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Notices 68807 

administrative efficiencies, and 

optimize use of available staff resources. 

Chapter RB5—Office of Information 

Technology 

Section RB5–10, Organization 

Delete in its entirety and replace with 

the following: 

The Office of Information Technology 

(RB5) is headed by the Chief Information 

Officer, who reports directly to the Chief 

Operating Officer (RB) who reports directly 

to the Administrator, Health Resources and 

Services Administration. The Office of 

Information Technology includes the 

following components: 

(1) Office of the Director (RB5); 

(2) Division of Capital Planning, 

Architecture and Project Management 

(RB52); 

(3) Division of Data and Information 

Services (RB55); 

(4) Division of Enterprise Solutions and 

Applications Management (RB56); 

(5) Division of IT Management Support 

Services (RB57); 

(6) Division of IT Operational Support 

Services (RB58); and 

(7) Division of Web Support and 

Collaboration Services (RB59). 

Section RB5–20, Functions 

(1) Delete the functional statement for 

the Office of Information Technology 

(RB5) and replace in its entirety. 

Office of the Director and Chief 

Information Officer (RB5) 

The Chief Information Officer (CIO) is 

responsible for the organization, 

management, and administrative 

functions necessary to carry out the 

responsibilities of the CIO including: (1) 

Provides organizational development, 

investment control, budget formulation 

and execution, policy development, 

strategic and tactical planning, and 

performance monitoring; (2) provides 

leadership in the development, review 

and implementation of policies and 

procedures to promote improved 

information technology management 

capabilities and best practices 

throughout HRSA; and (3) coordinates 

IT workforce issues and works closely 

with the departmental Office of Human 

Resources Management on IT 

recruitment and training issues. 

The Chief Information Security 

Officer (CISO), reporting to the CIO, 

provides leadership for, and 

collaborates with, Agency staff to 

oversee the implementation of security 

and privacy policy in the management 

of their IT systems, and plans all 

activities associated with Federal 

Information Security Management Act 

(FISMA) or other agency security and 

privacy initiatives, and also carries out 

the responsibilities including: (1) 

Implements, coordinates, and 

administers security and privacy 

programs to protect the information 

resources of HRSA in compliance with 

legislation, Executive Orders, directives 

of the Office of Management and Budget 

(OMB), or other mandated requirements 

e.g., Presidential Decision Directive 63, 

OMB Circular A–130, the National 

Security Agency, the Privacy Act, and 

other Federal agencies; (2) executes the 

Agency’s Risk Management Program, 

evaluates and assists with the 

implementation of safeguards to protect 

major information systems, and IT 

infrastructure; and (3) manages the 

development, implementation, and 

evaluation of the HRSA information 

technology security and privacy training 

program to meet the requirements as 

mandated by OMB Circular A–130, the 

Computer Security Act, and Privacy 

Act. 

Division of Capital Planning, 

Architecture and Project Management 

(RB52) 

The Division of Capital Planning, 

Architecture and Project Management 

(CPAPM) coordinates HRSA’s capital 

planning and investment control (CPIC), 

Enterprise Architecture (EA) and 

Enterprise Project Life Cycle (EPLC) 

processes for Information Technology 

(IT) including: (1) Provides direct 

planning development and support to 

assure that IT activities support and 

achieve agency business planning and 

mission objectives; (2) coordinates the 

development and review of policies and 

procedures for IT Capital Planning and 

Investment Control, Earned Value 

Management, Enterprise Architecture, 

IT project management, and the EPLC 

methodology; (3) supports the Budget 

Office in its evaluation of IT initiatives, 

and preparation of Agency, 

departmental and OMB Budget Exhibits 

and documents; (4) works to obtain 

required information and analyze it as 

appropriate; coordinates control and 

evaluation review of ongoing IT projects 

and investments, including support to 

the HRSA Enterprise Governance Board 

(EGB) and the Technical and Business 

Review Board (TBRB) in conducting 

such reviews; (5) operates a Project 

Management Office to promote, mentor 

and monitor effective use of the EPLC; 

improve project management skills, 

communications and functional user 

involvement; assists with project 

prioritization; reduce project risk and 

monitors progress and budget; and (6) 

coordinates the Agency’s Enterprise 

Architecture (EA) efforts with the 

capital planning process, ensuring the 

suitability and consistency of 

technology investments with HRSA’s 

EA and strategic objectives, and 

incorporating security standards as a 

component of the EA process. 

Division of Data and Information 

Services (RB55) 

The Division of Data and Information 

Services (DIS) develops and maintains 

an overall data and information 

management strategy for HRSA that is 

integrated with HHS and Governmentwide strategies, including: (1) Serves as 

HRSA’s coordination center for data 

transparency and Open Government 

data initiatives; (2) provides for HRSA’s 

data quality and ensures that data 

required for HRSA’s enterprise 

information requirements are captured 

in appropriate enterprise applications 

and that necessary data repositories are 

built and maintained; (3) evaluates and 

integrates emerging technology to 

facilitate the translation of data and 

information from data repositories into 

electronic formats for internal and 

external dissemination; (4) identifies 

information needs across HRSA and 

develops approaches for meeting those 

needs using appropriate technologies, 

including development and 

maintenance of an enterprise reporting 

platform and a geospatial data 

warehouse; (5) enhances and expands 

use and utility of HRSA’s data by 

providing basic analytic and user 

support, develops and maintains a range 

of information products for internal and 

external users, and demonstrates 

potential uses of information in 

supporting management decisions; (6) 

provides leadership and establishes 

policy to address legislative or 

regulatory requirements in its areas of 

responsibility; and (7) advises HRSA’s 

Chief Information Officer (CIO) on 

technical and analytical support it can 

make available to other HRSA Bureaus 

and Offices, particularly in support of 

the HRSA Public Health Steering 

Committee and the HRSA Office of 

Planning, Analysis and Evaluation 

(OPAE). 

Division of Enterprise Solutions and 

Applications Management (RB56) 

The Division of Enterprise Solutions 

and Applications Management (ESAM) 

provides leadership, consultation, and 

IT project management services in the 

definition of Agency business 

applications architectures, the 

engineering of business processes, the 

building and deployment of 

applications, and the development, 

maintenance and management of 

enterprise systems and data collections 

efforts, including: (1) Manages the 

application and data architecture 

definition, controlling software 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
68808 Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Notices 

configuration management, data 

modeling, database design, 

development, management and 

stewardship services for enterprise and 

small system business process owners; 

(2) manages the systems development 

lifecycle by facilitating business process 

engineering efforts, systems 

requirements definition, and provides 

oversight for application change 

management control; (3) provides 

enterprise application user training, 

Tier-3 assistance, and is responsible for 

end-to-end application building, 

deployment, maintenance and data 

security assurance; (4) defines the 

Agency business applications 

architecture, engineers technology for 

business processes, builds, deploys, 

maintains and manages enterprise 

systems and data collections efforts; (5) 

applies business applications 

architecture to process specific systems; 

(6) builds, deploys, maintains and 

manages organization specific systems 

and unique data collection efforts; and 

(7) directs database maintenance, 

modification, security, and management 

services for system process owners. 

Division of IT Management Support 

Services (RB57) 

The Division of IT Management 

Support Services (ITMSS) represents the 

CIO and other OIT divisions on IT 

policy and other administrative and IT 

management issues, including: (1) 

Collects customer feedback from the 

programmatic and business areas of the 

Agency and provides a central point for 

a variety of IT management and support 

functions; (2) provides oversight and 

management of budget formulation and 

execution; (3) serves as the focal point 

to HRSA contracts and provides 

centralized procurement services for the 

Office of Information Technology; (4) 

serves as the coordinator for Interagency and Service Level Agreements; 

(5) oversees the acquisition of HRSA IT 

hardware, wireless communication 

devices, and software licenses; (6) 

accountable for property life cycle 

management and tracking of Agencywide IT capital equipment; (7) provides 

oversight for outsourced network and 

desktop services to staff in HRSA 

Regional Offices (ROs); (8) provides 

telecommunications accountability, 

oversight, and support; and (9) serves as 

the focal point for HRSA-wide 

initiatives that impact the OIT. 

Division of IT Operational Support 

Services (RB58) 

The Division of IT Operational 

Support Services (ITOSS) (1) provides 

leadership, consultation, training, and 

management services for HRSA’s 

enterprise computing environment; (2) 

directs and manages the support and 

acquisition of HRSA network and 

desktop hardware, servers, wireless 

communication devices, and software 

licenses; (3) is responsible for the HRSA 

Data Center and the operation and 

maintenance of a complex, highavailability network infrastructure on 

which mission-critical applications are 

made available 24 hours per day, 7 days 

per week; (4) controls infrastructure 

configuration management, installations 

and upgrades, security perimeter 

protection, and system resource access; 

(5) coordinates IT activities for 

Continuity of Operations Planning 

(COOP) Agency-wide including 

provisioning and maintaining IT 

infrastructure and hardware at 

designated COOP locations to support 

emergency and COOP requirements; (6) 

maintains workstation hardware and 

software configuration management 

controls; (7) in close coordination with 

the CISO, the ITOSS implements HRSA 

level policies, procedures, guidelines, 

and standards for the incorporation of 

intrusion detection systems, 

vulnerability scanning, forensic and 

other security tools used to monitor 

automated systems and subsystems to 

safeguard HRSA’s electronic 

information and data assets; (8) the 

Chief Technology Officer (CTO), 

reporting to the ITOSS Division Director 

is responsible for assessing emerging 

technologies and the subsequent impact 

on current infrastructure restraints and 

program objectives; (9) coordinates and 

engages with all OIT Divisions and 

Branches to insure that advanced 

technology is being utilized to achieve 

program objectives through innovative 

technology use; and (10) provides 

leadership and establishes policy and 

provides oversight for Agency IT 

configuration management. 

Division of Web Support and 

Collaboration Services (RB59) 

The Division of Web Support and 

Collaboration Services (WSCS) (1) 

provides consultation, assistance and 

services to HRSA to promote and 

manage information dissemination, 

collaboration and business process 

improvement solutions through the use 

of Web-based tools; (2) in collaboration 

with the Office of Communications, is 

responsible for the design, deployment 

and maintenance of HRSA’s internal 

and external Web sites including 

development and implementation of 

related policies and procedures; and (3) 

supports the collaboration and business 

needs of HRSA by providing and 

supporting an enterprise-wide 

collaboration platform, business process 

management tools and Webconferencing tools. 

Section RB5–30, Delegations of 

Authority 

All delegations of authority and redelegations of authority made to HRSA 

officials that were in effect immediately 

prior to this reorganization, and that are 

consistent with this reorganization, 

shall continue in effect pending further 

re-delegation. 

This reorganization is upon date of 

signature. 

Dated: November 1, 2010. 

Mary K. Wakefield, 

Administrator. 

[FR Doc. 2010–28189 Filed 11–8–10; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

Agency Information Collection 

Activities: Free Trade Agreements 

AGENCY: U.S. Customs and Border 

Protection, Department of Homeland 

Security. 

ACTION: 30-day notice and request for 

comments; Extension and revision of an 

existing information collection: 1651– 

0117. 

SUMMARY: U.S. Customs and Border 

Protection (CBP) of the Department of 

Homeland Security will be submitting 

the following information collection 

request to the Office of Management and 

Budget (OMB) for review and approval 

in accordance with the Paperwork 

Reduction Act: Free Trade Agreements. 

This is a proposed extension of an 

information collection that was 

previously approved. CBP is proposing 

that this information collection be 

extended with a change to the burden 

hours. This document is published to 

obtain comments from the public and 

affected agencies. This proposed 

information collection was previously 

published in the Federal Register on 

September 7, 2010 (Volume 75, Page 

54352), allowing for a 60-day comment 

period. This notice allows for an 

additional 30 days for public comments. 

This process is conducted in accordance 

with 5 CFR 1320.10. 

DATES: Written comments should be 

received on or before December 9, 2010. 

ADDRESSES: Interested persons are 

invited to submit written comments on 

this proposed information collection to 

the Office of Information and Regulatory 

Affairs, Office of Management and 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1