69680 Federal Register / Vol. 75, No. 219 / Monday, November 15, 2010 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Child Health and 

Human Development; Revision to 

Proposed Collection; Comment 

Request; the National Children’s 

Study, Vanguard (Pilot) 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: The National Children’s Study, 

Vanguard (pilot) Study. 

Type of Information Collection 

Request: Revision. 

Need and Use of Information 

Collection: 

The purpose of the proposed data 

collection is to continue the Vanguard 

phase of the National Children’s Study 

(NCS), to evaluate the feasibility, 

acceptability, and cost of recruitment 

strategies and study design elements for 

a prospective, national longitudinal 

study of child health and development. 

In combination, the substudies 

encompassed by the Vanguard phase 

will be used to inform the design of the 

Main Study of the National Children’s 

Study. 

Background 

The National Children’s Study is a 

prospective, national longitudinal study 

of the interaction between environment, 

genetics, and biological factors 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 includes 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 strategies, study logistics, 

and study visit measures that are to be 

used in the design of 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. 

The Vanguard Study is conducted 

through study locations across the 

United States. Seven of these locations 

began recruitment in the winter and 

spring of 2009, and an additional 30 

locations will begin recruiting in late 

2010. These 30 sites were added to the 

Vanguard Study to evaluate the 

feasibility, acceptability and cost of 

three separate recruitment strategies for 

enrollment of pregnant women into the 

NCS; additional study locations were 

established to yield greater precision in 

statistical analyses. The original seven 

sites used a household enumeration and 

screening strategy to identify eligible 

women for recruitment into the study. 

The 30 sites that entered the study in 

2010 are recruiting pregnant women as 

participants using three methods: (a) A 

provider-based recruitment method, 

where women are recruited via their 

health care providers; (b) an enhanced 

household enumeration method; and 

(c) a two-tiered recruitment procedure 

where women are offered participation 

in a lower-intensity data collection and 

then may be able to convert to a higherintensity data collection. These sites 

have been collecting data relating to the 

pre-pregnancy, pregnancy, and birth 

periods. The original seven Vanguard 

sites have been collecting data relating 

to the pre-pregnancy, pregnancy, and 

birth periods, as well as postnatal data 

collection points at 3-, 6-, 9- and 12- 

months of age. 

Methods 

We propose to continue data 

collection during this phase of the 

Vanguard Study among the 37 study 

locations up to and including the visit 

planned to take place when the sample 

children have reached 24 months of age. 

This would align study visits approved 

for the initial 7 Vanguard Study 

locations (which extend past the birth 

visit to include a 3-, 6-, 9-, 12-, 18- and 

24-month visit) with the study visits 

approved for the 30 additional 

Vanguard Study locations (which were 

initially proposed and approved up to 

and including the birth visit). Extending 

the data collection of the 30 additional 

Vanguard Study locations to 24 months 

of age would support rigorous, 

empirical evaluation of participant 

retention as it may relate to recruitment 

strategy. A strong understanding of how 

to encourage retention of study 

participants, particularly during the 

infancy and early childhood years, will 

be essential to planning the Main Study. 

Additionally, continuing data collection 

post-birth among the alternate 

recruitment strategy study locations 

allows us to generate additional data to 

inform the development of study visit 

procedures, both for future Vanguard 

study efforts and the Main Study. 

We will evaluate the feasibility 

(technical performance), acceptability 

(respondent tolerance and impact on 

study infrastructure), and cost 

(operations, time, and effort) of each 

recruitment and retention strategy using 

pre-determined measures. We will 

compare these findings and use them as 

a basis to inform the strategies, or 

combinations of strategies, that might be 

used in the Main Study of the NCS. 

Frequency of Response: See above 

descriptions. 

Affected Public: Pregnant women and 

their children. 

The additional annualized cost to 

respondents over the two-year data 

collection period for all three 

recruitment strategies combined is 

estimated at annualized respondent cost 

of $75,000 (based on $10 per hour). This 

is calculated as estimating 15,000 

respondents across all three recruitment 

strategies, contacted once per visit, at an 

estimated average of .5 hours per 

response, for a total estimated annual 

respondent burden as 7,500 hours. 

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) 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 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 219 / Monday, November 15, 2010 / Notices 69681 

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 E-mail 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: November 5, 2010. 

Sarah L. Glavin, 

Deputy Director, Office of Science Policy, 

Analysis and Communications, National 

Institute of Child Health and Human 

Development, National Institutes of Health. 

[FR Doc. 2010–28701 Filed 11–12–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; California Health Interview 

Survey Cancer Control Module (CHIS– 

CCM) 2011 (NCI) 

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 Cancer Institute (NCI), 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: California 

Health Interview Survey Cancer Control 

Module (CHIS–CCM) 2010. Type of 

Information Collection Request: 

Revision. Need and Use of Information 

Collection: The NCI has sponsored five 

Cancer Control Modules in the 

California Health Interview Survey 

(CHIS), and will be sponsoring a sixth 

to be administered in 2011. CHIS is a 

telephone survey that collects 

population-based, standardized healthrelated data to assess California’s 

progress in meeting Healthy People 

2010 objectives for the nation and the 

State. The CHIS sample is designed to 

provide statistically reliable estimates 

statewide, for California counties, and 

for California’s ethnically and racially 

diverse population. Initiated by the 

UCLA Center for Health Policy 

Research, the California Department of 

Health Services, and the California 

Public Health Institute, the survey is 

funded by a number of public and 

private sources. It was first administered 

in 2001 to 55,428 adults and 

subsequently in 2003 to 42,043 adults, 

in 2005 to 43,020 adults, and in 2007 to 

48,150 adults. These adults are a 

representative sample of California’s 

non-institutionalized population living 

in households. CHIS 2011 is planned for 

continual administration to 48,150 

adults and 3,316 adolescent 

Californians. This study will allow NCI 

to examine patterns and trends in 

cancer screening and follow-up, as well 

as to study other cancer-related topics 

such as tobacco control, diet, physical 

activity, obesity, and human 

papillomavirus. Additionally, CHIS is 

designed to be comparable to the 

National Health Interview Survey 

(NHIS) data in order to conduct 

comparative analyses. CHIS provides 

enhanced estimates for cancer risk 

factors and screening among racial/ 

ethnic minority populations. Frequency 

of Response: Once. Affected public: 

Individuals. Types of Respondents: U.S. 

adults and adolescents (persons 12 years 

of age and older). The total annual 

burden hours requested are 2,177 (see 

Table 1). There are no Capital Costs, 

Operating Costs, and/or Maintenance 

Costs to report. 

TABLE 1—ESTIMATES OF ANNUALIZED HOUR BURDEN

Type of respondent Form type Number of 

respondents 

Frequency of 

response 

Average time 

per response—minutes/hours Annual hour 

burden 

Adults ................................................ Adult Pilot ......................................... 50 1 8/60 

(0.133) 

6.67 

Adult Survey ..................................... 16,000 1 8/60 

(0.133) 

2,133.33 

Adolescents ....................................... Adolescent Pilot ............................... 6 1 2/60 

(0.033) 

0.20 

Adolescent Survey ........................... 1,100 1 2/60 

(0.033) 

36.67 

Total ........................................... ........................................................... 17,156 ........................ ........................ 2,176.87 

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 

proposed 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 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 Nancy Breen, PhD, 

Project Officer, National Cancer 

Institute, EPN 4094, 6130 Executive 

Boulevard MSC 7344, Bethesda, 

Maryland 20852–7344, or call non-toll 


srobinson on DSKHWCL6B1PROD with NOTICES