2926 Federal Register / Vol. 73, No. 11 / Wednesday, January 16, 2008 / Notices 

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 

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 

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 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 11 / Wednesday, January 16, 2008 / Notices 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 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, 

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 


jlentini on PROD1PC65 with NOTICES