14530 Federal Register / Vol. 77, No. 48 / Monday, March 12, 2012 / Notices 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: March 6, 2012. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2012–5818 Filed 3–9–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Child Health and 

Human Development; New Proposed 

Collection; Comment Request; 

Environmental Science Formative 

Research Methodology Studies for the 

National Children’s Study 

SUMMARY: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Institute of Child Health and 

Human Development (NICHD), the 

National Institutes of Health (NIH) will 

publish periodic summaries of proposed 

projects to be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

Proposed Collection: 

Title: Environmental Science 

Formative Research Methodology 

Studies for the National Children’s 

Study (NCS). Type of Information 

Collection Request: Generic Clearance. 

Need and Use of Information Collection: 

The Children’s Health Act of 2000 (Pub. 

L. 106–310) states: 

(a) Purpose.—It is the purpose of this 

section to authorize the National Institute of 

Child Health and Human Development* to 

conduct a national longitudinal study of 

environmental influences (including 

physical, chemical, biological, and 

psychosocial) on children’s health and 

development. 

(b) In General.—The Director of the 

National Institute of Child Health and 

Human Development* shall establish a 

consortium of representatives from 

appropriate Federal agencies (including the 

Centers for Disease Control and Prevention, 

the Environmental Protection Agency) to— 

(1) Plan, develop, and implement a 

prospective cohort study, from birth to 

adulthood, to evaluate the effects of both 

chronic and intermittent exposures on child 

health and human development; and 

(2) Investigate basic mechanisms of 

developmental disorders and environmental 

factors, both risk and protective, that 

influence health and developmental 

processes. 

(c) Requirement.—The study under 

subsection (b) shall— 

(1) Incorporate behavioral, emotional, 

educational, and contextual consequences to 

enable a complete assessment of the physical, 

chemical, biological, and psychosocial 

environmental influences on children’s wellbeing; 

(2) Gather data on environmental 

influences and outcomes on diverse 

populations of children, which may include 

the consideration of prenatal exposures; and 

(3) consider health disparities among 

children, which may include the 

consideration of prenatal exposures. 

To fulfill the requirements of the 

Children’s Health Act, the results of 

formative research will be used to 

maximize the efficiency (measured by 

scientific robustness, participant and 

infrastructure burden, and cost) of 

environmental sample collection 

procedures and technology, storage 

procedures, accompanying 

questionnaires, and assays, and thereby 

inform data collection methodologies 

for the National Children’s Study (NCS) 

Vanguard and Main Studies. With this 

submission, the NCS seeks to obtain 

OMB’s generic clearance to collect 

environmental samples from homes and 

child care settings, and conduct 

accompanying short surveys related to 

the physical and chemical environment. 

The NCS has obtained OMB’s generic 

clearance to conduct survey and 

instrument design and administration, 

focus groups, cognitive interviews, and 

health and social service provider 

feedback information collection 

surrounding outreach, recruitment and 

retention (OMB # 0925–0590; Expiration 

Date 9/30/2014). Under separate notice, 

the NCS is also requesting generic 

clearance to conduct formative research 

featuring biospecimen and physical 

measures (OMB # 0925–0647, 

Expiration Date 1/31/2015), 

neurodevelopmental (pending 

clearance), and study logistic (pending 

clearance) information collection. 

Separate and distinct generic clearances 

are requested to facilitate the efficiency 

of submissions and review of these 

projects as requested by the Office of 

Information and Regulatory Affairs. 

Background: 

The National Children’s Study is a 

prospective, national longitudinal study 

of the interaction between environment, 

genetics on child health and 

development. The Study defines 

‘‘environment’’ broadly, taking a 

number of natural and man-made 

environmental, biological, genetic, and 

psychosocial factors into account. By 

studying children through their 

different phases of growth and 

development, researchers will be better 

able to understand the role these factors 

have on health and disease. Findings 

from the Study will be made available 

as the research progresses, making 

potential benefits known to the public 

as soon as possible. The National 

Children’s Study is led by a consortium 

of federal partners: The U.S. Department 

of Health and Human Services 

(including the Eunice Kennedy Shriver 

National Institute of Child Health and 

Human Development and the National 

Institute of Environmental Health 

Sciences of the National Institutes of 

Health and the Centers for Disease 

Control and Prevention), and the U.S. 

Environmental Protection Agency. 

To conduct the detailed preparation 

needed for a study of this size and 

complexity, the NCS was designed to 

include a preliminary pilot study 

known as the Vanguard Study. The 

purpose of the Vanguard Study is to 

assess the feasibility, acceptability, and 

cost of the recruitment strategy, study 

procedures, and outcome assessments 

that are to be used in the NCS Main 

Study. The Vanguard Study begins prior 

to the NCS Main Study and will run in 

parallel with the Main Study. At every 

phase of the NCS, the multiple 

methodological studies conducted 

during the Vanguard phase will inform 

the implementation and analysis plan 

for the Main Study. 

In this request, the NCS is requesting 

generic approval from OMB for 

formative research activities relating to 

the collection, storage, management, 

and assay of environmental samples and 

accompanying questionnaires. The 

results from these formative research 

projects will inform the feasibility 

(scientific robustness), acceptability 

(burden to participants and study 

logistics) and cost of NCS Vanguard and 

Main Study environmental sample and 

information collection in a manner that 

minimizes public information collection 

burden compared to burden anticipated 

if these projects were incorporated 

directly into either the NCS Vanguard or 

Main Study. 

Frequency of Response: Annual [As 

needed on an on-going and concurrent 

basis]. Affected Public: Members of the 

public, researchers, practitioners, and 

other health professionals. Type of 

Respondents: Women of child-bearing 

age, fathers, public health and 

environmental science professional 

organizations and practitioners, and 

schools and child care organizations. 

These include both persons enrolled in 

the NCS Vanguard Study and their peers 

who are not participating in the NCS 

Vanguard Study. Annual reporting 

burden: See Table 1. The annualized 

cost to respondents is estimated at: 

$780,000 (based on $10 per hour). There 


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Federal Register / Vol. 77, No. 48 / Monday, March 12, 2012 / Notices 14531 

are no Capital Costs to report. There are no Operating or Maintenance Costs to 

report. 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN SUMMARY, ENVIRONMENTAL SCIENCE

Data collection activity Type of respondent 

Estimated 

number of 

respondents 

Estimated 

number of 

responses 

per 

respondent 

Average 

burden hours 

per response 

Estimated 

total annual 

burden hours 

requested 

Home Air ........................................... NCS participants .............................. 4,000 1 1 4,000 

Members of NCS target population 

(not NCS participants).

4,000 1 1 4,000 

Home Water ...................................... NCS participants .............................. 4,000 1 1 4,000 

Members of NCS target population 

(not NCS participants).

4,000 1 1 4,000 

Home Dust ........................................ NCS participants .............................. 4,000 1 1 4,000 

Members of NCS target population 

(not NCS participants).

4,000 1 1 4,000 

School and Child Care Facility Air .... NCS participants .............................. 4,000 1 1 4,000 

Members of NCS target population 

(not NCS participants).

4,000 1 1 4,000 

School and Child Care Facility Water NCS participants .............................. 4,000 1 1 4,000 

Members of NCS target population 

(not NCS participants).

4,000 1 1 4,000 

School and Child Care Facility Dust NCS participants .............................. 4,000 1 1 4,000 

Members of NCS target population 

(not NCS participants).

4,000 1 1 4,000 

Small, focused survey and instrument design and administration.NCS participants .............................. 4,000 2 1 8,000 

Members of NCS target population 

(not NCS participants).

4,000 2 1 8,000 

Health and Social Service Providers 2,000 1 1 2,000 

Community Stakeholders ................. 2,000 1 1 2,000 

Focus groups .................................... NCS participants .............................. 2,000 1 1 2,000 

Members of NCS target population 

(not NCS participants).

2,000 1 1 2,000 

Health and Social Service Providers 2,000 1 1 2,000 

Community Stakeholders ................. 2,000 1 1 2,000 

Cognitive interviews .......................... NCS participants .............................. 500 1 2 1,000 

Members of NCS target population 

(not NCS participants).

500 1 2 1,000 

Total ........................................... ........................................................... 69,000 ........................ ........................ 78,000 

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) Whether the proposed collection of 

information is necessary for the proper 

performance of the function of the 

agency, including whether the 

information will have practical utility; 

(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 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. Sarah L. 

Glavin, Deputy Director, Office of 

Science Policy, Analysis and 

Communication, National Institute of 

Child Health and Human Development, 

31 Center Drive Room 2A18, Bethesda, 

Maryland 20892, or call non-toll free 

number (301) 496–1877 or Email your 

request, including your address to 

glavins@mail.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: March 6, 2012. 

Sarah L. Glavin, 

Deputy Director, Office of Science Policy, 

Analysis and Communications National 

Institute of Child Health and Human 

Development. 

[FR Doc. 2012–5946 Filed 3–9–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; Web-Based Assessment of 

the NHLBI Clinical Studies Support 

Center (CSSC) 

SUMMARY: In compliance with the 

requirement of Section 3506(c) (2) (A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Heart, Lung, and Blood 

Institute (NHLBI), the National 

Institutes of Health (NIH), will publish 

periodic summaries of proposed 

projects to the Office of Management 

and Budget (OMB) for review and 

approval. 

Proposed Collection: Title: Web-Based 

Assessment of the Clinical Studies 

Support Center (CSSC). Type of 

Information Collection Request: New. 


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