The Statement of Organization, Functions, and Delegations of Authority, 2926-2927 [08-125]
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Information Collection Request:
Renewal of OMB Clearance 0925–0543.
Need and Use of Information
Collection: This study will assess the
relation between select environmental
factors and human fecundity and
fertility. This research originally
proposed to recruit 960 couples who are
interested in becoming pregnant and
willing to participate in a longitudinal
study. Fewer than expected couples
were enrolled during the first three
years of the project (n=350),
predominantly due to the fact that more
couples were ineligible for participation
than had been originally estimated. In
light of this fact, the revised study plan
is to enroll a total of 500 couples (i.e.,
150 additional couples), a sample size
that will not compromise the main
study objectives. Fecundity will be
measured by the time required for the
couples to achieve pregnancy, while
fertility will be measured by the ability
of couples to have a live born infant.
Couples who are unable to conceive
within 12 months of trying or who
experience a miscarriage also will be
identified and considered to have
fecundity-related impairments. The
study’s primary environmental
exposures include: Organochlorine
pesticides and polychlorinated
biphenyls; metals; fluorinated
compounds; phytoestrogens; and
phthalates. A growing body of literature
suggests these compounds may exert
effects on human reproduction and
development; however, definitive data
are lacking serving as the impetus for
this study. Couples will participate in a
20–30 minute baseline interview and be
instructed in the use of home fertility
monitors and pregnancy kits for
counting the time required for
pregnancy and detecting pregnancy.
Blood and urine samples will be
collected at baseline from both partners
of the couple for measurement of the
environmental exposures. Two semen
samples from male partners and two
saliva samples from female partners also
will be requested. Semen samples will
be used to assess male fecundity as
measured primarily by sperm
concentration and morphology. Saliva
samples will be used for the
measurement of cortisol levels as a
marker of stress among female partners
so that the relation between
environmental factors, stress and human
reproduction can be assessed. The
findings will provide valuable
information regarding the effect of
environmental contaminants on
sensitive markers of human
reproduction and development, filling
critical data gaps. Moreover, these
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environmental exposures will be
analyzed in the context of other lifestyle
exposures, consistent with the manner
in which human beings are exposed.
Frequency of Response: Following the
baseline interview, couples will each
complete a five-minute daily diary on
select lifestyle factors. Women will
perform daily fertility testing and
pregnancy testing at day of expected
menses using a dipstick test in urine.
Each test will require approximately
five minutes for completion. This
testing and diary reporting is required
only up to the time women become
pregnant, which on average should be in
2–3 months. Men will provide two
semen samples, a month apart, requiring
approximately 20 minutes for each
collection, and women will collect two
saliva samples, a month apart, requiring
approximately five minutes.
Participating couples will be given a
choice to submit their information by
mail or to send it electronically to the
Data Coordinating Center. This option
will be available throughout data
collection in the event couples change
their minds about how they would like
to submit information. Bio-specimens
will be collected by study participants
and research nurses, where appropriate,
and forwarded in prepaid delivery
packages to the study’s laboratories.
Affected Public: Individuals from
participating communities. Type of
Respondents: Men and women aged 18–
40 years. Revised Estimated Number of
Respondents: 1,000. Revised Estimated
Number of Response Sets per
Respondent: 6 per women and 3 per
men over approximately two years.
Average Burden Hours per Response:
.1947 for women and .31975 for men.
Revised Estimated Total Annual Burden
Hours Requested: 1,658 for women and
889 for men. The revised burden
estimates represent a 48 percent
reduction in the originally requested
burden. There is no cost to respondents.
There are no Capital Costs to report.
There are no Operating or Maintenance
Costs to report.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) The necessity of the proposed
collection of information for the proper
performance of the function of the
agency, including the practical utility of
the information; (2) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
ways to enhance the quality, utility, and
clarity of the information to be
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collected; and (4) ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Dr. Germaine Buck
Louis, Senior Investigator and Chief,
Epidemiology Branch, DESPR, NICHD,
NIH, 6100 Executive Blvd., Room 7B03,
Rockville, Maryland 20852, or call nontoll-free number (301) 496–6155 or email your request, including your
address to: gb156i@nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60-days of the date of
this publication.
Dated: January 3, 2008.
Paul Johnson,
NICHD Project Clearance Liaison, National
Institutes of Health.
[FR Doc. E8–609 Filed 1–15–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
The Statement of Organization,
Functions, and Delegations of
Authority
Part N, National Institutes of Health
(NIH), of the Statement of Organization,
Functions, and Delegations of Authority
for the Department of Health and
Human Services (DHHS) (40 FR 22859,
May 27, 1975, as amended most recently
at 72 FR 57595, October 10, 2007, and
redesignated from Part HN as Part N at
60 FR 56605, November 9, 1995), is
amended as set forth below to reflect the
transfer of the functions of the Chief
Information Officer (CIO) from the
Center for Information Technology (NU,
formerly HNU) to the Office of the
Director (NA, formerly HNA).
Section N–B, Organization and
Functions, under the heading Center for
Information Technology (NU, formerly
HNU), is amended as follows:
(1) Replace the current section NU
(formerly HNU) with the following:
Center for Information Technology
(NU, formerly HNU). (1) Provides
leadership for the determination of NIH
computational and telecommunications
needs at all levels and oversees the
development of appropriate
infrastructure support to meet identified
E:\FR\FM\16JAN1.SGM
16JAN1
jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 11 / Wednesday, January 16, 2008 / Notices
needs; (2) develops, operates, and
maintains a state-of-the-art regional
computer facility and provides overall
guidance based on legislation and
policy that is responsive to the NIH
mission; (3) establishes and operates the
necessary organization and
infrastructure to assure appropriate
security, connectivity, and interoperability across the NIH Institutes and
Centers (ICs), off-campus locations, and
remote access; (4) collaborates on, and
provides for, research activities in the
computational biosciences and
statistics; (5) develops, administers, and
manages NIH systems, and provides
consulting services to the ICs, in
support of administrative and business
applications; and (6) serves as a Federal
Data Processing Center for
administrative, biomedical, and
statistical computing, provides data
processing and high performance
computing facilities and integrated
telecommunications data networks, and
provides services to the DHHS and other
Federal agencies.
(2) Delete in their entirety the
statements for Office of the Deputy CIO
(NU9, formerly HNU9); the Information
Technology Policy and Review Office
(NU92, formerly HNU92, the
Information Security and Awareness
Office (NU93, formerly HNU93); the
Information Technology Acquisitions
Services Office (NU94, formerly
HNU94); and the Office of the Chief
Information Technology Architect
(NU19, formerly HNU19).
(3) Section N–B, Organization and
Functions, under the heading Office of
the Director (NA, formerly HNA), is
amended as follows:
Under the heading Office of the
Director (NA, formerly HNA),
immediately following the statement for
Office of Portfolio Analysis and
Strategic Initiatives (HNAU) insert the
following:
Office of the Chief Information Officer
(NAV, formerly HNAV). (1) Advises the
NIH Director on the strategic direction
and management of significant NIH
Information Technology (IT) program
and policy activities; (2) provides
leadership for the enhancement of NIH
IT capabilities, scientific and research
computing services, and enterprise
systems through policies, guidelines
and standards, budget management, and
lifecycle performance monitoring; (3)
directs the establishment of a common
infrastructure that optimizes NIH’s IT
investments and that can adapt to
emerging technologies and service
models; (4) leads IT security initiatives
to protect and secure NIH’s information
assets; (5) oversees the NIH-wide IT
investment portfolio, inclusive of IC,
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CIT, and enterprise systems; (6)
approves the progress of enterprise
projects through the DHHS Enterprise
Performance Life Cycle (EPLC); (7)
identifies critical IT issues and analyzes,
plans, and leads NIH’s implementation
of special DHHS or Federal initiatives
related to management of IT resources;
(8) leads IT governance structure to
align IT with NIH strategies and
objectives; (9) leads the implementation
of enterprise architecture policies,
standards, and practices; (10) leads NIH
IT support efforts on medical initiatives
such as Electronic Health Record; and
(11) provides leadership and focus
within NIH for the development and
implementation of policy and standards
in IT by identifying, documenting, and
communicating issues, problems, and
solutions to the NIH community in a
comprehensive way.
Information Technology Policy and
Review Office (NAV2, formerly HNAV2).
Advises and assists the NIH Chief and
Deputy Chief Information Officers in
managing NIH IT resources and
investments through (1) development,
implementation, and oversight of NIH
IT policy and guidance; (2)
interpretation and implementation of
laws, regulations, and DHHS, Office of
Management and Budget (OMB), and
other Federal mandates; (3)
development and oversight of IT capital
planning and investment control
activities; (4) coordination and
preparation of IT budget and review
documents; (5) development of IT
management tools and training; and (6)
provision of staff support to CIO
committees and special initiatives,
studies, and projects.
Information Security and Awareness
Office (NAV3, formerly HNAV3).
Provides guidance to the NIH Chief and
Deputy Chief Information Officers
regarding IT security, planning, and
budget activities by (1) leading the
development of program goals, policies,
standards, and procedures for the NIH
IT Security program; (2) providing
guidance to ICs for security of
information in accordance with the
Privacy Act, the Computer Security Act
of 1987, the Information Technology
Management Reform Act (ITMRA),
OMB, and DHHS guidance; (3)
providing support to the NIH IT
Management Committee (ITMC); (4)
conducting NIH-wide IT security
activities; (5) managing an NIH Incident
Response Team; (6) managing an NIH
Risk Management and Oversight
Program; and (7) managing an NIH IT
Security Awareness and Training
Program.
Information Technology Acquisition
Services Office (NAV4, formerly
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2927
HNAV4). Advises the NIH Chief and
Deputy Chief Information Officers on IT
contract expenditures and IT trends by
(1) maintaining awareness of federally
mandated laws, regulations, and
standards as they relate to IT acquisition
documents and IT investments; (2)
participating in NIH-wide committees
that impact NIH CIO initiatives,
policies, and standards; (3) working
closely with other ICs to ensure that
NIH CIO initiatives and practices are
reflected in IT submissions to DHHS
and OMB; (4) assisting in the
preparation of Statements of Work and
supporting documentation such as
schedules, evaluation criteria, and
checklists required to implement the
ITMRA, maintaining consistency with
NIH/DHHS/OMB policies; (5) assisting
NIH program managers in identifying
appropriate mechanisms to satisfy their
IT requirements, including NIH
acquisition resources; and (6) advising
NIH IT project managers on contract/
task order management, administrative
strategies, problem resolution, and
techniques via meetings, e-mail,
handbooks, and/or briefings.
Information Technology Architecture
Office (NAV5, formerly HNAV5). (1)
Advises the CIO on IT enterprise
architecture for the NIH; (2) provides
leadership to the development and
management of an NIH enterprise
architecture; (3) develops principles,
policy, and technology standards to
guide IT systems design and integration;
(4) leads and/or evaluates enterprise
projects and technologies for
compliance and integration within IT
architecture; (5) coordinates and
represents IT enterprise architecture for
the NIH; and (6) provides leadership,
management, and implementation of
transforming technologies for NIH such
as Federal Public Key Infrastructure,
Enterprise Application Integration
Infrastructure, and Enterprise Identity
Management Infrastructure, including
the redesign of the NIH Enterprise
Directory.
Delegations of Authority: All
delegations and redelegations of
authority to officers and employees of
NIH which were in effect immediately
prior to the effective date of this
reorganization and are consistent with
this reorganization shall continue in
effect, pending further redelegation.
Dated: January 7, 2008.
Elias A. Zerhouni,
Director, National Institutes of Health.
[FR Doc. 08–125 Filed 1–15–08; 8:45 am]
BILLING CODE 4140–01–M
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Agencies
[Federal Register Volume 73, Number 11 (Wednesday, January 16, 2008)]
[Notices]
[Pages 2926-2927]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 08-125]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
The Statement of Organization, Functions, and Delegations of
Authority
Part N, National Institutes of Health (NIH), of the Statement of
Organization, Functions, and Delegations of Authority for the
Department of Health and Human Services (DHHS) (40 FR 22859, May 27,
1975, as amended most recently at 72 FR 57595, October 10, 2007, and
redesignated from Part HN as Part N at 60 FR 56605, November 9, 1995),
is amended as set forth below to reflect the transfer of the functions
of the Chief Information Officer (CIO) from the Center for Information
Technology (NU, formerly HNU) to the Office of the Director (NA,
formerly HNA).
Section N-B, Organization and Functions, under the heading Center
for Information Technology (NU, formerly HNU), is amended as follows:
(1) Replace the current section NU (formerly HNU) with the
following:
Center for Information Technology (NU, formerly HNU). (1) Provides
leadership for the determination of NIH computational and
telecommunications needs at all levels and oversees the development of
appropriate infrastructure support to meet identified
[[Page 2927]]
needs; (2) develops, operates, and maintains a state-of-the-art
regional computer facility and provides overall guidance based on
legislation and policy that is responsive to the NIH mission; (3)
establishes and operates the necessary organization and infrastructure
to assure appropriate security, connectivity, and inter-operability
across the NIH Institutes and Centers (ICs), off-campus locations, and
remote access; (4) collaborates on, and provides for, research
activities in the computational biosciences and statistics; (5)
develops, administers, and manages NIH systems, and provides consulting
services to the ICs, in support of administrative and business
applications; and (6) serves as a Federal Data Processing Center for
administrative, biomedical, and statistical computing, provides data
processing and high performance computing facilities and integrated
telecommunications data networks, and provides services to the DHHS and
other Federal agencies.
(2) Delete in their entirety the statements for Office of the
Deputy CIO (NU9, formerly HNU9); the Information Technology Policy and
Review Office (NU92, formerly HNU92, the Information Security and
Awareness Office (NU93, formerly HNU93); the Information Technology
Acquisitions Services Office (NU94, formerly HNU94); and the Office of
the Chief Information Technology Architect (NU19, formerly HNU19).
(3) Section N-B, Organization and Functions, under the heading
Office of the Director (NA, formerly HNA), is amended as follows:
Under the heading Office of the Director (NA, formerly HNA),
immediately following the statement for Office of Portfolio Analysis
and Strategic Initiatives (HNAU) insert the following:
Office of the Chief Information Officer (NAV, formerly HNAV). (1)
Advises the NIH Director on the strategic direction and management of
significant NIH Information Technology (IT) program and policy
activities; (2) provides leadership for the enhancement of NIH IT
capabilities, scientific and research computing services, and
enterprise systems through policies, guidelines and standards, budget
management, and lifecycle performance monitoring; (3) directs the
establishment of a common infrastructure that optimizes NIH's IT
investments and that can adapt to emerging technologies and service
models; (4) leads IT security initiatives to protect and secure NIH's
information assets; (5) oversees the NIH-wide IT investment portfolio,
inclusive of IC, CIT, and enterprise systems; (6) approves the progress
of enterprise projects through the DHHS Enterprise Performance Life
Cycle (EPLC); (7) identifies critical IT issues and analyzes, plans,
and leads NIH's implementation of special DHHS or Federal initiatives
related to management of IT resources; (8) leads IT governance
structure to align IT with NIH strategies and objectives; (9) leads the
implementation of enterprise architecture policies, standards, and
practices; (10) leads NIH IT support efforts on medical initiatives
such as Electronic Health Record; and (11) provides leadership and
focus within NIH for the development and implementation of policy and
standards in IT by identifying, documenting, and communicating issues,
problems, and solutions to the NIH community in a comprehensive way.
Information Technology Policy and Review Office (NAV2, formerly
HNAV2). Advises and assists the NIH Chief and Deputy Chief Information
Officers in managing NIH IT resources and investments through (1)
development, implementation, and oversight of NIH IT policy and
guidance; (2) interpretation and implementation of laws, regulations,
and DHHS, Office of Management and Budget (OMB), and other Federal
mandates; (3) development and oversight of IT capital planning and
investment control activities; (4) coordination and preparation of IT
budget and review documents; (5) development of IT management tools and
training; and (6) provision of staff support to CIO committees and
special initiatives, studies, and projects.
Information Security and Awareness Office (NAV3, formerly HNAV3).
Provides guidance to the NIH Chief and Deputy Chief Information
Officers regarding IT security, planning, and budget activities by (1)
leading the development of program goals, policies, standards, and
procedures for the NIH IT Security program; (2) providing guidance to
ICs for security of information in accordance with the Privacy Act, the
Computer Security Act of 1987, the Information Technology Management
Reform Act (ITMRA), OMB, and DHHS guidance; (3) providing support to
the NIH IT Management Committee (ITMC); (4) conducting NIH-wide IT
security activities; (5) managing an NIH Incident Response Team; (6)
managing an NIH Risk Management and Oversight Program; and (7) managing
an NIH IT Security Awareness and Training Program.
Information Technology Acquisition Services Office (NAV4, formerly
HNAV4). Advises the NIH Chief and Deputy Chief Information Officers on
IT contract expenditures and IT trends by (1) maintaining awareness of
federally mandated laws, regulations, and standards as they relate to
IT acquisition documents and IT investments; (2) participating in NIH-
wide committees that impact NIH CIO initiatives, policies, and
standards; (3) working closely with other ICs to ensure that NIH CIO
initiatives and practices are reflected in IT submissions to DHHS and
OMB; (4) assisting in the preparation of Statements of Work and
supporting documentation such as schedules, evaluation criteria, and
checklists required to implement the ITMRA, maintaining consistency
with NIH/DHHS/OMB policies; (5) assisting NIH program managers in
identifying appropriate mechanisms to satisfy their IT requirements,
including NIH acquisition resources; and (6) advising NIH IT project
managers on contract/task order management, administrative strategies,
problem resolution, and techniques via meetings, e-mail, handbooks,
and/or briefings.
Information Technology Architecture Office (NAV5, formerly HNAV5).
(1) Advises the CIO on IT enterprise architecture for the NIH; (2)
provides leadership to the development and management of an NIH
enterprise architecture; (3) develops principles, policy, and
technology standards to guide IT systems design and integration; (4)
leads and/or evaluates enterprise projects and technologies for
compliance and integration within IT architecture; (5) coordinates and
represents IT enterprise architecture for the NIH; and (6) provides
leadership, management, and implementation of transforming technologies
for NIH such as Federal Public Key Infrastructure, Enterprise
Application Integration Infrastructure, and Enterprise Identity
Management Infrastructure, including the redesign of the NIH Enterprise
Directory.
Delegations of Authority: All delegations and redelegations of
authority to officers and employees of NIH which were in effect
immediately prior to the effective date of this reorganization and are
consistent with this reorganization shall continue in effect, pending
further redelegation.
Dated: January 7, 2008.
Elias A. Zerhouni,
Director, National Institutes of Health.
[FR Doc. 08-125 Filed 1-15-08; 8:45 am]
BILLING CODE 4140-01-M