Statement of Organization, Functions and Delegations of Authority, 62420-62421 [2011-26007]
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Federal Register / Vol. 76, No. 195 / Friday, October 7, 2011 / Notices
Administration, 10903 New Hampshire
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MD 20993–0002, 301–796–5402, e-mail:
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Registration: You are encouraged to
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spaces, meals and snacks provided,
travel expenses incurred by invited
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The registration process, including
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handled by CPDD. Additional
information on the workshop, program
agenda, and registration procedures is
available on the Internet at https://
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(FDA has verified the NIDA Web site
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any subsequent changes to the Web site
after this document publishes in the
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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 https://
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comments to the Division of Dockets
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Administration, 5630 Fishers Lane, rm.
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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
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VerDate Mar<15>2010
16:33 Oct 06, 2011
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Management between 9 a.m. and 4 p.m.,
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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 https://
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:
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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