Statement of Organization, Functions and Delegations of Authority, 62420-62421 [2011-26007]

Download as PDF jlentini on DSK4TPTVN1PROD with NOTICES 62420 Federal Register / Vol. 76, No. 195 / Friday, October 7, 2011 / Notices Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 5144, Silver Spring, MD 20993–0002, 301–796–5402, e-mail: Corinne.moody@fda.hhs.gov. Accommodations: Attendees are responsible for their own accommodations. Reservations can be made on a space-available basis at The Legacy Hotel and Meeting Centre (see Location). Registration: You are encouraged to register at your earliest convenience. A registration fee will be charged to help defray the costs of rental of the meeting spaces, meals and snacks provided, travel expenses incurred by invited speakers, and other costs. The registration fee is $325. Registration fees will be waived for invited speakers and administrative personnel. The registration process, including payment of the registration fee, will be handled by CPDD. Additional information on the workshop, program agenda, and registration procedures is available on the Internet at http:// www.seiservices.com/nida/1014102/. (FDA has verified the NIDA Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.) If you need special accommodations due to a disability, please contact Ellen B. Geller or Corinne Moody (see Contact Person) at least 7 days in advance of the workshop. Comments: FDA is holding this public workshop to obtain information about the science of abuse liability assessment. The workshop will center on status, needs, new approaches, and paradigms regarding preclinical studies, challenges associated with human subject abuse potential studies, and adverse events that signal abuse potential during clinical trials. The deadline for submitting comments about this public workshop is January 10, 2012. Regardless of attendance at the public workshop, interested persons may submit either electronic or written comments regarding the issues presented at the workshop. Submit electronic comments to http:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets VerDate Mar<15>2010 16:33 Oct 06, 2011 Jkt 226001 Management between 9 a.m. and 4 p.m., Monday through Friday. SUPPLEMENTARY INFORMATION: In the Federal Register of January 27, 2010 (75 FR 4400), FDA announced the publication of a draft guidance for industry on ‘‘Assessment of Abuse Potential of Drugs,’’ and requested comments on the draft guidance. There were 23 submissions to the docket with approximately 750 comments received from academia, industry, and the government. General and specific comments were received on every section of the draft guidance. The comment period has closed and FDA is gathering current information that may relate to some of the comments received. Questions remain, for example, about when abuse potential studies should be conducted, and about the signals of abuse or potential abuse observed in clinical trials. This workshop is another mechanism for continuation of discussion with interested stakeholders before FDA finalizes the draft guidance. Transcripts: Please be advised that as soon as a transcript is available it will be accessible at http:// www.regulations.gov. It may be viewed at the Division of Dockets Management (see Comments). A transcript will also be available in either hardcopy or on CD–ROM, after submission of a Freedom of Information request. Written requests are to be sent to the Division of Freedom of Information (ELEM– 1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. Dated: October 3, 2011. David Dorsey, Acting Associate Commissioner for Policy and Planning. [FR Doc. 2011–25918 Filed 10–6–11; 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 76 FR 54236 dated August 31, 2011). This notice reflects organizational changes to the Health Resources and PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 Services Administration. Specifically, this notice updates the Office of Information Technology (RB5) functional statement. The update to the functional statement will better align functional responsibility with improved security management capabilities and improved alignment of current security initiatives within the Office of Information Technology (RB5). Chapter RB5—Office of Information Technology Section RB5–10, Organization The Office of Information Technology (RB5) is headed by the Director and Chief Information Officer, who reports directly to the Chief Operating Officer. Section RB5–20, Functions (1) Delete the functional statement for the Office of the Director (RB5) and replace in its entirety; and (2) delete the functional statement for the Division of IT Operational Support Services (RB58) and replace in its entirety. Office of the Director (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, E:\FR\FM\07OCN1.SGM 07OCN1 Federal Register / Vol. 76, No. 195 / Friday, October 7, 2011 / Notices jlentini on DSK4TPTVN1PROD with NOTICES 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; (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; (4) assesses all new emerging technologies and impact on technology integration on HRSA missions and program objectives; (5) provides leadership for strategic planning that leverages information systems security, program strategies, and advanced technology integration to achieve program objectives through innovative technology use; (6) the HRSA Incident Response Center (HIRC) provides a centralized, responsive resource for computer security incident reporting, management, and situational awareness of the Department’s information security posture; (7) provides services include computer security situational awareness reports, computer forensics, cyberrelated advisories, as well as cyber alerts, warnings, and Block/Watch lists are utilized and disseminated; (8) the HIRC coordinates with other Agencies and organizations for computer security and maintains a lab where new products are tested to insure that HRSA is utilizing state of the art, cutting edge technologies to ensure the secure operation of the HRSA infrastructure; and (9) provides leadership for ongoing cyber protection and incident detection response, reporting, and handling in accordance with OMB and departmental guidance. 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 VerDate Mar<15>2010 16:33 Oct 06, 2011 Jkt 226001 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) 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; (8) 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 (9) provides leadership and establishes policy and provides oversight for Agency IT configuration management. 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 effective upon date of signature. Dated: September 30, 2011. Mary K. Wakefield, Administrator. [FR Doc. 2011–26007 Filed 10–6–11; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; Comment Request; A Generic Submission for Theory Development and Validation (NCI) Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on August 2, 2011 SUMMARY: PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 62421 (76 FR 46307) and allowed 60-days for public comment. No public comment were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: A Generic Submission for Theory Development and Validation (NCI). Type of Information Collection Request: NEW. Need and Use of Information Collection: In order to carry out NCI’s legislative mandate to conduct and support research with respect to the causes and prevention of cancer, it is beneficial for NCI, through initiatives in the Behavioral Research Program (BRP), to conduct and support behavioral research informed by and informing theory. Formative research in the area of theory development and validation would provide the basis for developing effective cancer prevention and control strategies, allow for a better understanding of theoretical constructs that influence decisions and actions related to cancer, and ultimately contribute to reducing the U.S. cancer burden. Data collections that result from this generic clearance would inform and clarify the use of theory in BRPsupported initiatives and funding announcements. Specifically, this research would allow NCI to conduct research to: (1) Identify psychological, biobehavioral, demographic, and individual difference predictors of cancer prevention and control behaviors and outcomes; (2) Develop and refine integrative theories; (3) Identify and observe theoretical and innovative trends in cancer prevention and control research; and (4) Determine feasibility and usefulness of collaborative and multidisciplinary approaches to cancer prevention and control. Frequency of Response: Will be determined by each project. Affected Public: Individuals or households; Businesses or other for profit; Not-for-profit institutions; Federal Government; State, Local, or Tribal Government. Type of Respondents: Members of the public including, but not limited to health professionals, physicians, and researchers. Table 1 outlines the estimated burden hours and cost required for a three-year approval of this generic submission. E:\FR\FM\07OCN1.SGM 07OCN1

Agencies

[Federal Register Volume 76, Number 195 (Friday, October 7, 2011)]
[Notices]
[Pages 62420-62421]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-26007]


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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 76 
FR 54236 dated August 31, 2011).
    This notice reflects organizational changes to the Health Resources 
and Services Administration. Specifically, this notice updates the 
Office of Information Technology (RB5) functional statement. The update 
to the functional statement will better align functional responsibility 
with improved security management capabilities and improved alignment 
of current security initiatives within the Office of Information 
Technology (RB5).

Chapter RB5--Office of Information Technology

Section RB5-10, Organization

    The Office of Information Technology (RB5) is headed by the 
Director and Chief Information Officer, who reports directly to the 
Chief Operating Officer.

Section RB5-20, Functions

    (1) Delete the functional statement for the Office of the Director 
(RB5) and replace in its entirety; and (2) delete the functional 
statement for the Division of IT Operational Support Services (RB58) 
and replace in its entirety.

Office of the Director (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,

[[Page 62421]]

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; (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; (4) assesses all new emerging technologies and 
impact on technology integration on HRSA missions and program 
objectives; (5) provides leadership for strategic planning that 
leverages information systems security, program strategies, and 
advanced technology integration to achieve program objectives through 
innovative technology use; (6) the HRSA Incident Response Center (HIRC) 
provides a centralized, responsive resource for computer security 
incident reporting, management, and situational awareness of the 
Department's information security posture; (7) provides services 
include computer security situational awareness reports, computer 
forensics, cyber-related advisories, as well as cyber alerts, warnings, 
and Block/Watch lists are utilized and disseminated; (8) the HIRC 
coordinates with other Agencies and organizations for computer security 
and maintains a lab where new products are tested to insure that HRSA 
is utilizing state of the art, cutting edge technologies to ensure the 
secure operation of the HRSA infrastructure; and (9) provides 
leadership for ongoing cyber protection and incident detection 
response, reporting, and handling in accordance with OMB and 
departmental guidance.

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, high-availability 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) 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; (8) 
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 (9) provides 
leadership and establishes policy and provides oversight for Agency IT 
configuration management.

Section RB5-30, Delegations of Authority

    All delegations of authority and re-delegations 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 effective upon date of signature.

    Dated: September 30, 2011.
Mary K. Wakefield,
Administrator.
[FR Doc. 2011-26007 Filed 10-6-11; 8:45 am]
BILLING CODE 4165-15-P