August 12, 2005 Population based Pilot Study of Children's Environmental Health in Support of the National Children's Study Supporting Statement Docket #: ORD 2005 0010 ICR # 2187.01 Contact Information Pauline Mendola US EPA/ NHEERL Human Studies Division MD 58A Research Triangle Park NC 27711 919 966 6953 Mendola. Pauline@ epa. gov i TABLE OF CONTENTS FOR ICR SUPPORTING STATEMENT Part A of the ICR Supporting Statement................................................................................. 4 1. Identification of the Information Collection................................................................. 4 1( a) Title of the Information Collection........................................................................... 4 1( b) Short Characterization/ Abstract ............................................................................... 4 2. Need for and Use of the Collection................................................................................ 4 2( a) Need/ Authority for the Collection............................................................................ 4 2( b) Practical Utility/ Users of the Data............................................................................ 5 3. Non duplication, Consultations, and Other Collection Criteria.................................. 7 3( a) Non duplication....................................................................................................... 7 3( b) Public Notice Required Prior to ICR Submission to OMB ....................................... 7 3( c) Consultations........................................................................................................... 7 3( d) Effects of Less Frequent Collection ......................................................................... 9 3( e) General Guidelines .................................................................................................. 9 3( f) Confidentiality......................................................................................................... 9 3( g) Sensitive Questions................................................................................................ 10 4. The Respondents and the Information Requested........................................................ 11 4( a) Respondents/ SIC Codes......................................................................................... 11 4( b) Information Requested........................................................................................... 12 5. The Information Collected   Agency Activities, Collection Methodology, and Information Management................................................................................................... 31 5( a) Agency Activities .................................................................................................. 31 5( b) Collection Methodology and Management............................................................. 31 5( c) Small Entity Flexibility.......................................................................................... 32 5( d) Collection Schedule ............................................................................................... 32 6. Estimating the Burden and Cost of the Collection..................................................... 34 6( a) Estimating Respondent Burden.............................................................................. 34 6( b) Respondent Costs .................................................................................................. 39 6( c) Estimating Agency Burden and Cost...................................................................... 40 6( d) Estimating the Respondent Universe and Total Burden and Costs.......................... 41 6( e) Bottom Line Burden Hours and Costs Tables......................................................... 44 6( f) Reasons for Change in Burden............................................................................... 45 6( g) Burden Statement.................................................................................................. 45 Part B. Required Items for Information Collections Involving Statistical Sampling ... 47 1. Survey Objectives, Key Variables, and Other Preliminaries..................................... 47 1( a) Survey Objectives.................................................................................................. 47 1( b) Key Variables ........................................................................................................ 48 1( c) Statistical Approach............................................................................................... 48 1( d) Feasibility.............................................................................................................. 49 2. Survey Design .............................................................................................................. 49 2( a) Target Population and Coverage ............................................................................ 49 2( b) Sample Design....................................................................................................... 52 2( c) Precision Requirements ......................................................................................... 54 3. Pretests and Pilot Tests ............................................................................................... 59 4. Collection Methods and Follow Up ........................................................................ 59 ii 4( a) Collection Methods................................................................................................ 59 4( b) Survey Response and Follow Up ........................................................................... 61 5. Analyzing and Reporting Survey Results ............................................................... 61 5( a) Data Preparation .................................................................................................... 61 5( b) Analysis................................................................................................................. 62 5( c) Reporting Results .................................................................................................. 62 Appendix A: Copy of 60 Day Federal Register Notice ( FR) and Supporting Documentation ................................................................................................................................................. 63 1. Copy of the FRN Used To Solicit Public Comments.................................................. 63 2. Draft of the 30 Day FRN............................................................................................. 78 References ............................................................................................................................... 83 Appendix B: Final Visit Schedule and Burden Estimates ..................................................... 84 Appendix C: Questionnaire Instrument Table ...................................................................... 94 iii Table of Exhibits Exhibit 1. Non EPA Individuals Consulted on the Pilot Study 8 Exhibit 2. NCS Interagency Coordinating Committee 8 Exhibit 3 Domains for maternal and partner interview/ questionnaires 13 Exhibit 4. Schedule of Preconception Visits 33 Exhibit 5. Schedule of Post conception Visits 33 Exhibit 6. Number of Eligible Women Screened and Enrolled, and Number of Births Expected by Group 35 Exhibit 7. Burden Estimates for Screening and Preconception Visits 36 Exhibit 8. Burden Estimates for Pregnancy and Birth/ Childhood Visits 37 Exhibit 9. Estimated Respondent Burden in Hours 38 Exhibit 10. Total Estimated Burden and Costs: Screening, Preconception, Pregnancy,

Birth, and Childhood Visits 40 Exhibit 11. Agency Cost Annual Burden 41 Exhibit 12. Respondent Universe Estimates for Screening and Preconception Visits 43 Exhibit 13. Respondent Universe Estimates for Pregnancy and Birth/ Childhood Visits 44 Exhibit 14. Annual Burden by Respondent Type 46 Exhibit 15. Births in 2003 by Mother's County of Residence 51 Exhibit 16. Estimated Power to Compare Screening Response Rates between Two Equal Subgroups of Housing Units 56 Exhibit 17. Estimated Power to Compare Enrollment Rates between Two Equal Subgroups of Women 57 Exhibit 18. Estimated Power to Compare Newborn Enrollment Rates between Two Equal Subgroups of Women Giving Birth During the Study 58 4 Part A of the ICR Supporting Statement 1. Identification of the Information Collection 1( a) Title of the Information Collection The title of the information collection is: " Population based pilot study of children's environmental health in support of the National Children's Study." This study will be referred to as the " Pilot Study" within this Supporting Statement.

** This ICR requires a " Privacy Impact Assessment ( P. I. A.)" It is currently being conducted and will be submitted to OMB at its completion.

1( b) Short Characterization/ Abstract The U. S. Environmental Protection Agency ( EPA) is conducting this information collection activity in partnership with the National Children's Study ( NCS) Program Office at the National Institute of Child Health and Human Development ( NICHD) of the National Institutes of Health ( NIH) as well as the other NCS lead agencies: the Centers for Disease Control and Prevention ( CDC) and the National Institute of Environmental Health Sciences ( NIEHS) at NIH. The information will be used by federal and non federal entities planning the implementation and operations for the NCS.

The purpose of this Pilot Study is to test logistics, protocols and procedures considered for implementation in the NCS, a long term study of the influence of environmental factors on child health and development. The goal is to improve the efficiency and enhance the likelihood of successfully recruiting and retaining the study subjects in the NCS by testing procedures for population based sampling and subject recruitment, proposed study logistics and estimates of subject burden, and evaluating data collection strategies including interviews and acquisition of biologic and environmental samples. Further details on the NCS, including the NCS Study Plan,

can be found at www. nationalchildrensstudy. gov.

2. Need for and Use of the Collection 2( a) Need/ Authority for the Collection The goal of the proposed information collection is to test the methods of populationbased recruitment and implementation protocols for the NCS. The Pilot Study will provide relevant data on the response rate, completion rate and acceptability of data collection procedures, and burden for various survey methods proposed for the NCS. This collection 5 supports activities outlined in the Children's Health Act of 2000 ( PL 106 310). This law specifically authorizes the conduct of a national longitudinal study of environmental influences on children's health and development and directs the participation of EPA, in collaboration with its federal partners, in this effort. The full NCS meets several scientific needs, including:

  Conducting a national, longitudinal cohort study. To make valid conclusions about relationships between exposures and health outcomes in children that can be generalized to the U. S. population, the NCS requires a national probability based sampling design that includes children and families from different areas of the U. S. with diverse backgrounds. The NCS will use a long term prospective cohort study design, beginning before birth until children are 21 years old, giving researchers an unmatched data source from which to study children's health.

  Investigating exposure from a broader perspective. The NCS will examine exposure from various perspectives, including biological, physical, genetic, social, cultural, and chemical factors that may affect a child's health and development.

  Examining many complex hypotheses on children's health and the environment. The NCS will address research questions of public health importance for children's wellbeing. Results from the NCS will help identify environmental factors that are harmful as well as those factors that are helpful or harmless.

The NCS held an expert panel Sampling Design Workshop on March 21 22, 2004, that recommended pursuing a population based sampling strategy, but noted that " The lack of precedent for a study of this size and complexity at least in the United States dictate the need for pilot efforts to assess the feasibility of this approach. The pilot study needs to be carefully planned and implemented so that the most effective methods of recruitment and data collection are identified." The report can be found on the NCS web site at http:// www. nationalchildrensstudy. gov/ events/ workshops/ samplingdesign032004. cfm. This Pilot Study is designed to provide that information.

2( b) Practical Utility/ Users of the Data The NCS Study Plan outlines a very complex design for sampling and data collection.

EPA anticipates that the data collected in this Pilot Study will be very useful to the NCS planners, including federal partners at NIH and CDC as well as to the non federal contractors that will manage the NCS Coordinating Center and Vanguard Study Centers. Study data,

including information on logistics, subject burden and acceptance of procedures, will be provided to the study planners, including the NCS Program Office, NCS Interagency Coordinating Committee ( ICC) and NCS Steering Committee, on a regular basis to guide and improve the efficiency and effectiveness of plans for full NCS implementation. 6 7 3. Non duplication, Consultations, and Other Collection Criteria 3( a) Non duplication The Pilot Study is designed specifically to support the National Children's Study, a large prospective cohort study of the influence of the environment on child health and development.

Early in the planning phase, a review of existing studies and data available from previous federal surveys was conducted by the President's Task Force on Environmental Health Risks and Safety Risks to Children. This panel of experts determined that a new effort was needed to comprehensively address children's environmental health. This Pilot Study can provide information about how well the proposed NCS methods work in field settings. We know of no other effort at this time that will provide the important data required for this major interagency effort to study children's environmental health.

3( b) Public Notice Required Prior to ICR Submission to OMB The initial 60 day Federal Register Notice ( FR) for this proposed data collection was published on April 12, 2005. A copy of the 60 day FR is included in Part B Section 6 and is also available on the E docket ORD 2005 0010, located at:

http:// docket. epa. gov/ edkpub/ do/ EDKStaffCollectionDetailViewByID? collectionId= ORD 2005

0010.

During the 60 day FR period, one comment was received and addressed by EPA. The comment is included in Appendix A, along with a copy of the response. More details on the comment can also be found in Section 3( c) Consultations.

3( c) Consultations The following non EPA individuals, listed in Exhibit 1, were consulted to provide advice and guidance on all aspects of the design and conduct of the study. 8 Exhibit 1. Non EPA Individuals Consulted on the Pilot Study Name Phone Number Affiliation Amoke Alakoye, MHS 301 230 4656 RTI International Ruth Brenner, MD, MPH 301 496 5581 NICHD, NIH, DHHS Margie Byron, MS 919 541 6086 RTI International Linda Dimitropoulos, PhD 312 456 5246 RTI International Warren Galke, PhD 301 594 1336 NICHD, NIH, DHHS Richard Kwok, PhD 919 316 3336 RTI International Sharon Myers, MPH 919 541 7316 RTI International Roy Whitmore, PhD 919 541 5809 RTI International The ICC, which is responsible for planning the NCS, has provided extensive feedback on the planning for this Pilot Study. ICC members are listed in Exhibit 2. Concept clearance was also sought from the NCS chartered federal advisory committee. A subcommittee reviewed and approved the Pilot Study concept. The Pilot Study was presented to the full NCS Advisory Committee at their public meeting in April 2005 with opportunity for discussion among committee members as well as comment from the public audience.

Exhibit 2. NCS Interagency Coordinating Committee Name Phone Number Affiliation Elizabeth H. Blackburn, BSN 202 564 2192 Office of Children's Health Protection, EPA Amy Branum, MSPH 301 458 4731 National Center for Health Statistics ( NCHS), CDC, DHHS Adolfo Correa, MD, PhD 404 498 3811 National Center for Birth Defects and Developmental Disabilities ( NCBDDD), CDC, DHHS Sarah Keim, MA 301 435 6923 NICHD, NIH, DHHS Woodie Kessel, MD, MPH 240 453 8256 Office of the Secretary, DHHS Mark Klebanoff, MD, MPH 301 496 5267 NICHD, NIH, DHHS Pauline Mendola, PhD 919 966 6953 National Health and Environmental Effects Research Laboratory ( NHEERL), EPA Sheila A. Newton, MS, PhD 919 541 4343 NIEHS, NIH, DHHS James J. Quackenboss, MS 702 798 2642 National Exposure Research Laboratory ( NERL), EPA Peter C. Scheidt, MD, MPH 301 496 6287 NICHD, NIH, DHHS Kenneth Schoendorf, MD, MPH 301 458 4486 NCHS, CDC, DHHS Sherry G. Selevan, PhD 202 564 3312 National Center for Environmental Assessment ( NCEA), EPA Marshalyn Yeargin Allsopp, MD 404 498 3842 NCBDDD, CDC, DHHS 9 3( d) Effects of Less Frequent Collection The study design and visit schedule of the Pilot Study is based on the proposed design and visit schedule in the NCS Study Plan. The study planners for the NCS have optimized the number of data collection time points to gather comprehensive, relevant information while minimizing burden on participants and study staff alike. Given that exposures can change over time and the impact of exposure on health and development can be different at various developmental stages during pregnancy and childhood, it is important to collect data frequently enough to assess the environmental impact on child health. In order to maximize the utility of the Pilot Study for the NCS, the same frequency of subject contact is proposed.

3( e) General Guidelines The Pilot Study will conform to all OMB general guidelines for information collections.

Women who are potential participants in the study areas will be contacted for a household screening by field interviewers and provided with basic information about the study to determine if they are eligible to participate. Potential participants will be screened to determine their likelihood of pregnancy status and confirm their age eligibility. Potential participants may also be contacted via telephone, if necessary. Respondents interested in participating will be invited to complete a schedule of telephone and home visits similar to those proposed for the NCS.

3( f) Confidentiality Because this study will collect sensitive and personal information, data must be protected to maintain confidentiality. We will adhere to several procedures and processes for maintaining confidentiality, including:

  assigning unique case identification numbers to identify study participants;

  de identifying data to strip any identifying information from the data, i. e., keeping the identifiable information in separate files for which a restricted number of people will have access;

  obtaining a certificate of confidentiality for the study to provide assurance to study participants;

  obtaining signed Assurances of Confidentiality from all project staff pledging their commitment to protecting the study data;

  conducting annual and refresher training according to the Office of Human Research Protections ( OHRP) guidelines; and 10   training study staff in the application of Health Insurance Portability and Accountability Act ( HIPAA) regulations regarding obtaining protected health information from health providers or insurance companies ( i. e., covered entities).

Study procedures will be developed to ensure the physical security of hardcopy data forms and the electronic security of computerized data. We will create unique study identifiers to protect the confidentiality of study participants. All completed hardcopy questionnaires will be stored in locked files in secure facilities. EPA will regularly monitor contractor compliance with confidentiality requirements. Any electronic copies of data containing personal information will be kept in password protected computers or CDs in a locked filing cabinet in a secure facility.

No reports will contain any uniquely identifying information about the participants.

3( g) Sensitive Questions This Pilot Study will collect longitudinal data from pregnant women and women attempting pregnancy and their husbands or partners. The study will ask sensitive questions in several questionnaire domains including:

  alcohol   demographics ( e. g., marital status, income)

  tobacco ( self)

  family history   financial security   medical history   mental health   reproductive health ( i. e., current contraceptive method, pregnancy status, reproductive history)

  paternity The NCS Study Plan ( http:// www. eps. gov/ spg/ HHS/ NIH/ NICHD/ RFP NICHD 2004

07/ Attachments. html) proposes the need for information on a variety of potentially sensitive topics both to determine eligibility ( such as factors related to likelihood of pregnancy:

contraceptive use, etc.) and to examine multiple exposures, including physical and social factors that may be important for child health outcomes. This Pilot Study addresses similar domains in order to field test the methods and acceptability of these questions including a test of processes,

procedures, question content, question layout, questionnaire design, and questionnaire modality. 11 The informed consent process will alert respondents to the broad range of sensitive questions. Respondents can refuse to answer any question and still participate in the study.

The sensitive portions of the interview will be self administered via Audio Computer

Assisted Self Interviewing ( ACASI) so that the interviewers will not know respondents' answers.

ACASI enables respondents to complete the questions privately by either listening to them using an audio headset or reading them on the computer screen, and then entering their own responses directly into the computer. This method maximizes respondent privacy and confidentiality.

4. The Respondents and the Information Requested 4( a) Respondents/ SIC Codes Respondents for this information collection will be recruited among women residing in selected areas of Forsyth and Davidson Counties of North Carolina across three major categories: ( 1) pregnant women aged 18 and older, ( 2) non pregnant women aged 18 to 40, and ( 3) women enrolled at the hospital after giving birth. Non pregnant women will be further stratified as proposed in the NCS Study Plan:

  High likelihood for pregnancy   women who are not using any method of birth control and are attempting to become pregnant.

  Moderate likelihood for pregnancy   women who are using a birth control method with less than 90 percent effectiveness and are sexually active.

  Low likelihood for pregnancy   women who are not sexually active or are using a birth control method with greater than 90% effectiveness.

Respondents for this study will also include partners ( e. g., husbands or domestic partners)

and children of the participating women.

Because the Pilot Study will also collect information from hospitals and clinics, Standard Industrial Codes ( SIC) will define these sources of information. SIC codes chosen for this study can be referenced from OSHA " Division I: Services, Major Group 80: Health Services" and include:

  SIC Code 8011   Offices and Clinics of Doctors of Medicine. This code is included because we anticipate collecting biologic specimens at private clinics from study participants.

  SIC Code 8062  General Medical and Surgical Hospitals. This code is included because we will be working with hospitals and study participants to collect biologic specimens at birth ( e. g., cord blood, infant blood spot, placental weight, etc.). 12 4( b) Information Requested ( i) Data items, including recordkeeping requirements In order to determine an individual's eligibility for the study, it will first be necessary to determine whether any eligible participants reside in the identified geographic areas through a process known as " rostering." Trained field staff will visit every dwelling unit within an identified geographic area in order to roster each household ( Instrument # 1 in Appendix B) to determine whether any potentially eligible participants are available. Rostering is expected to take 10 minutes per household. Should any potentially eligible participants be identified, these individuals will be screened ( Instrument # 2 in Appendix B) in order to determine whether or not they are truly eligible and interested in participating in the study. Screening is expected to take 10 minutes per respondent. Once a participant volunteers and is enrolled into the study, a variety of information will be collected using a series of questionnaires at different points in time during the study as noted below. 13 Exhibit 3 Domains for maternal and partner interview/ questionnaires Preconception ( 16 Mths) Pregnancy visits ( 9 months) Childhood visits ( 18 months)

Roster Screen Initial # 2 # 3 # 4 Phone FU First home* # 1 OGT T # 2 # 3 First home* Birth 1 month 6 month 12 month 18 month Instrument # 1 2 3, 4, 5 6, 7 8 9 10 13, 14 11, 12 15,

16 17,

18, 19 20, 21 22 23, 24,

25, 26 27 28 Acceptability y ( w& p) y y y y ( w& p) y ( w& p) y y y ( w& p) y y y y Activity maternal f f+ f ( w& p) u f Alcohol f ( w& p) u u u f ( w& p) u ( w& p) u u f ( w& p) u ( w& p) u Chemical exposures f ( w& p) u u u f ( w& p) u ( w& p) u u f ( w& p) u u ( w& p) u u Child development y y y+ y+ y+

Demographics Name y Age/ DOB y y y ( p) y ( p) y ( p)

Gender y Race/ ethn y y ( p) y ( p) y ( p)

Nativity y y ( p) y ( p) y ( p)

Hispanic y y ( p) y ( p) y ( p)

Education y y ( p) y ( p) y ( p)

Home Address y y u u u y u u u u u ( w& p) u Telephone number y u u u u u u u u ( w& p) u Plans to move y y u u u y u u Income f ( w& p) f ( w& p) f ( w& p) u Language y 14 Roster Screen Initial # 2 # 3 # 4 Phone FU first home* # 1 OGTT # 2 # 3 first home* Birth 1 month 6 month 12 month 18 month Dental health f f u f Diet  Child Breastfeeding/

Formula feeding intent f f u u u Solid foods f u+ u+

Other food f u+ u+

Diet maternal ( SAQ) t t Diet maternal f f f Feelings about pregnancy y ( w& p) y ( w& p) y ( w& p)

Health Care Access to care f f u+ f Insurance f f u f Prenatal care b b f Home Environment / Cond.* f f f Heat and Air Conditioning f f f Cooking f f f Pesticides and Lawn Care f f f u u Renovations and Paint f f f u u Water Damage/ Mold f f f u u Household composition f f f Infant safety f f 15 Roster Screen Initial # 2 # 3 # 4 Phone FU first home* # 1 OGT T # 2 # 3 first home* Birth 1 month 6 month 12 month 18 month Medical ( pers and family hx) Allergies ( detailed) f ( w& p) u u u f ( w& p) u ( w& p) u u f ( w& p) u u ( w& p) u u Asthma ( detailed) f ( w& p) u u u f ( w& p) u ( w& p) u u f ( w& p) u u ( w& p) u u Other chronic cond f ( w& p) u u u f ( w& p) u ( w& p) u u f ( w& p) u u ( w& p) u u Family hx f ( w& p) f ( w& p) f ( w& p)

Pregnancyrelated cond f f u u f Medical Hx  Child f f u+ u+ u+

Well baby care f u u Medications  Rx and OTC f u u u f u u u f u u Mental health ( SAQ) MOS Social Support t ( w& p) t ( w& p ) t ( w& p)

CES Depression t ( w& p) t ( w& p ) t ( w& p)

Life events t ( w& p) t ( w& p ) t ( w& p)

Cohen perceived stress t ( w& p) t ( w& p ) t ( w& p)

Financial security t ( w& p) t ( w& p ) t ( w& p)

Pregnancy related anxiety t Neighborhood* f f u f u u Occupation f ( w& p) u u u f+

( w& p) u ( w& p) u u+ f+ ( w& p) u u ( w& p) u u 16 Roster Screen Initial # 2 # 3 # 4 Phone FU first home* # 1 OGT T # 2 # 3 first home** Birth 1 month 6 month 12 month 18 month Partner name/ address y u u u u u u u u Pets and pests f f u f u u Post partum depression f f Pregnancy Status/ Risk Recognition of Preg y u u u u u u u u Current contraception y u u u u u u u Desire to become preg. y u u u u u u u Sexual Activity y u u OB/ GYN y y y y y y u u Hospital/ Facility for Delivery y y y y y y u u u u Last Menstrual Period / Due Date y f u u u u u u u u Reproductive health Menstrual History f f f Pregnancy History f f f Sleep y y y y y Supplements,

Vitamins f u u u f u u u f u u Tobacco  self and ets f ( w& p) u u u f ( w& p) u ( w& p) u u f ( w& p) u+

( w& p) u+ u+

f = full; f+ = full, revised; u = update; u+ = update + new questions; b = basic; y = yes; ( w& p) = woman and partner; t = take home * enrolled at 1st trimester pregnancy ** enrolled at 2nd or 3rd trimester pregnancy or delivery * Will collect full instrument (# 29) any time the participant has moved to a new address 17 QUESTIONNAIRE DESIGN The questionnaires have been designed to collect information as part of a longitudinal cohort study of children's health. A careful review of questionnaires and domains employed in other studies of children's health, notably the Pregnancy, Infection and Nutrition study ( PIN), the Pregnancy Risk Assessment Monitoring System ( PRAMS) and the Avon Longitudinal Study of Parents and Children ( ALSPAC), was conducted to maximize the utility of the study design and question elements. Data collection will begin during the preconception period and continue until the child is 18 months of age. A maximum of 19 questionnaires will be administered to each participant; 5 take home questionnaires and 14 in person interviews that will contain questions administered to any participant via Computer Assisted Personal Interviewing ( CAPI). Women enrolled during pregnancy will receive fewer questionnaires and study visits than women enrolled during their preconception period. Similarly, partners of women enrolled during pregnancy will receive fewer questionnaires than those enrolled during preconception. Women will also be asked to complete five self administered questionnaires on paper and return them by mail. Partners of the female participants who choose to participate in the study will receive a maximum of six questionnaires ( three in person interviews and three self administered questionnaires).

The questionnaires are divided into sections ( domains) of related questions. Questions for most domains are asked initially during the first visit after enrollment and updated during each of the following visits ( up to 14 times during the study follow up period). Responses that are expected to remain relatively constant are queried less frequently. Certain questions pertain only to specific stages in preconception, pregnancy or childhood. Personal identifying information included on the questionnaires will not become part of the statistical database. Exhibit 3 illustrates which domains are queried at each visit, who responds ( the women alone or both women and their partners) and if the questionnaire is a take home or in person interview.

Data on household composition ( 4 questions minimum, 7 questions maximum) are required to enumerate household members of specific ages (> 18 years, 5 17 years, < 5 years) and determine whether the female participant acts as a caregiver to any household member. This information is 18 needed to define the social and family context that may influence the health of the mother and the child. This section is included in any first home visit.

During screening, the female participant is asked to provide information about her husband /

partner ( 2 question minimum, 6 questions maximum) in order capture information on marital status and identifying information for her partner ( name, telephone number, address) so that he or she can be contacted and invited to participate in the study. Partner update information ( 1 question minimum, 5 questions maximum) is collected in the initial interview and all preconception interviews, the first trimester pregnancy visit and the one month child visit.

The section on pregnancy status ( 2 question minimum, 6 questions maximum) is included to determine if women followed during preconception have become pregnant and if a new participant is currently pregnant. If a participant is pregnant, her due date, the name and address of her doctor and hospital for delivery are obtained so that she can be located and followed during her delivery. For women who are not currently pregnant, information regarding desire to become pregnant and method of birth control is captured so that her likelihood of becoming pregnant can be established. Likelihood of pregnancy is an important parameter in the study to determine the woman's data collection schedule. This section is included at screening.

Pregnancy status information ( 4 questions minimum and maximum) is updated during all preconception interviews, as well as the 6 month, 12 month , and 18 month childhood visits.

The occupation section ( 9 question minimum, 31 question maximum) captures information on student and employment status. For the women who work, their occupation, industry, hours per week, whether they do shift work or hold additional jobs are also collected. These data are needed because work related exposure may be important risk factors for the birth outcomes of interest and factors related to child development. After the child is born, we ask about early childhood education or other child care arrangements, including those associated with employment and those outside the employment setting, because the amount of time children spend in these settings has been shown to have an impact on child development. The full complement of questions is administered at the initial home visit. We update occupational information ( 2 question minimum, 23 question maximum) at all preconception interviews 19 ( except telephone follow up), any first home visit, pregnancy visits except for OGTT, and at all childhood visits except birth.

Chemical exposures are of interest for this study ( 1 question minimum, 48 question maximum).

Twelve exposures that are known or suspected to affect birth outcomes and child development are included in this section ( e. g., solvents, paint, lead, anesthetic gases, x rays, dental amalgam,

pesticides, beauty products, cleaning products, coal tar, carbon black, metal fumes). The question format will allow the frequency and duration of exposure at work, home or for hobbies to be estimated. Since the timing of exposure is of interest with birth outcomes, questions updating chemical exposures information are asked during each follow up interview. The chemical exposures section is included for all preconception visits except telephone follow up;

any first home visit; pregnancy visits 1, 2, and 3; and 1 month, 6 month, 12 month, and 18

month childhood visits.

Home environment and conditions are measured as an exposure of interest for this study ( 21 question minimum, 36 question maximum). Environmental characteristics and conditions that may influence human health and birth outcomes through their effect on indoor air quality and home contamination are queried in this section. These characteristics and conditions include home water sources, cooking practices, pesticide use and lawn care, renovations and paint, water damage and mold. This full section is included in the questionnaire during any first home interview and the first home visit after a participant moves. However, should an eligible study participant move to a new location ( and remains eligible), they will be asked to fill out the full module ( Instrument # 29) to determine the characteristics of their new home environment at the next regularly scheduled home visit. An update of these questions ( 7 questions minimum, 16 questions maximum) is collected in the six month and 18 month visits to capture changes that occur in the household over time.

Pets and pests are potential sources of exposure that may affect birth outcome and children's health ( 3 question minimum, 7 question maximum). Questions in this section capture specific information on the number of domestic and outdoor pets, flea and tick control methods and the presence of rodents and roaches inside the home. This section is included in the initial interview 20 and all subsequent follow up interviews as the timing of exposure is an important factor in assessing the impact of exposures on birth outcomes and children's health such as the development of asthma and allergy. This section is included in the initial visit, any first home visit, the first trimester pregnancy visit, and 1 month and 12 month childhood visits.

A full assessment of personal and family medical history ( 8 question minimum, 13 question maximum) is included in the questionnaire because the mother's health as well as her medical history may influence the health of her baby or confound or modify the association of other exposures with the birth or the child's health outcomes. Specific questions on allergies, asthma,

hypertension, diabetes, hyper cholesterol, anemia, heart problems and family history of hypertension, diabetes, hyper cholesterol and heart problems are included. The full complement of questions in this section is asked during the initial visit. Personal and family medical history is updated at all preconception visits except for telephone follow up, any first home visit, all pregnancy visits except for OGTT, and at all childhood visits except for birth. An event form ( Instrument # 30) is provided for the woman to report any illnesses, non routine doctor visits,

emergency room visits, or hospital admissions for herself or her child during the course of the study. This form is to be used as needed and is intended to collect adverse health outcomes that may arise during the study.

Both prescription and over the counter medications ( 2 question minimum, 14 question maximum) taken by the mother may influence birth outcome or children's health. The specific medications included in this section of the questionnaire are antibiotics, decongestants, pain killers, anti depressant medication, acetaminophen, ibuprofen, cough medicine, cold medicine,

aspirin and other medicines and are collected at the initial interview. Since timing of medication use during preconception, pregnancy, and breastfeeding is needed to determine the effect of these substances on children's health, prescription and over the counter medications are updated ( 2 question minimum, 16 question maximum) during all preconception visits except telephone follow up, any first home visit, all pregnancy visits except for OGTT, and 1 month and 12

month childhood visits.

Maternal use of supplements and vitamins ( 2 question minimum, 7 question maximum) may have an influence on both birth outcome and maternal health. Maternal use of commonly used supplements is queried by showing the woman a list including, fiber supplements, multivitamins, 21 herbal supplements, beta carotene, Vitamin A, Vitamin C, Vitamin E, Calcium, Vitamin D, B 6,

B Complex, Brewer's yeast, cod liver oil, Coenzyme Q, fish oil, folic acid, glucosamine,

hydroxytryptophen, iron, niacin, selenium, zinc, aloe vera, bilberry, cayenne, Dong Kuai,

Echinacea, evening primrose oil, feverfew, garlic, ginger, ginkgo biloba, ginseng, golden seal,

grapeseed extract, kava, milk thistle, Siberian ginseng, St. John's Wart, Valerian root during the initial visit. Vitamin and supplement use is updated at the all preconception visits except the telephone follow up, any first home visit, all pregnancy visits except OGTT, and at 6 month, 12

month childhood visits.

Health care access and insurance ( 3 question minimum, 4 question maximum) are part of the social and economic context that may influence birth outcomes and children's health directly or confound or modify the association of other exposures and outcomes of interest. This section is included during the initial interview. Health care access and insurance, with special attention to prenatal care, is updated ( 4 question minimum, 6 question maximum) during the first and third trimester visits.

Elements on a woman's reproductive history including menstrual and pregnancy history may influence subsequent birth outcomes ( 4 question minimum, 8 question maximum). Since reproductive history will not change over time, questions in this section are included only on the questionnaire administered during any first home visit.

Maternal demographic information on age, race or ethnicity, marital status, nativity and educational attainment is collected ( 9 question minimum, 12 question maximum) during screening. These variables may be determinants in birth outcome and children's health as well as potential confounders of associations of interest. Home address and plans to move are also collected as this information is needed to facilitate follow up and determine eligibility; this information is updated ( 2 question minimum, 3 question maximum) during the telephone follow up, preconception visits two, three, and four, the first trimester pregnancy visit, and the 1, 6, and 12 month childhood visits. The section on income includes four questions on income level,

source of income, and number of people ( adults and children) dependent on the income. Income 22 questions are not asked at screening but during the initial home interview and updated at the 18 month childhood visit.

Maternal consumption of alcohol during pregnancy ( 1 question minimum, 5 question maximum)

is well known to affect fetal development and alcohol is found in breast milk of women who consume alcohol. Alcohol consumption may be a confounder or modifier of associations of interest in this study. The question format allows calculation of average alcohol consumption during the past 2 years, consumption during the past 3 months, frequency during an average week, frequency of consumption of 5 or more alcoholic beverages and type of alcoholic beverage to be estimated. Alcohol consumption is reported during the initial home interview,

and is updated ( 1 question minimum, 3 questions maximum) in all preconception visits except telephone follow up, any first home visit, all pregnancy visits except OGTT, and 6 month and 18 month childhood visits Maternal tobacco use and exposure to second hand smoke are also a well known factors that affect health outcomes of the fetus and child ( 7 question minimum, 11 question maximum).

Specific questions relating to the type of tobacco smoke, smoking in the last 30 days, 2 years,

and current smoking are included. Questions on tobacco smoke exposure are included during the initial home interview and updated ( 6 question minimum, 10 question maximum) in all preconception visits except telephone follow up; any first home visit; all pregnancy visits except OGTT; and 6 month, 12 month, and 18 month childhood visits.

Acceptability of the study to the participants is an important parameter in order to maximize the utility of the Pilot Study for the NCS ( 5 question minimum, 10 question maximum). Factors that increase participant satisfaction can be incorporated into the larger study and difficulties may be avoided. Open ended questions are included to more completely explore the participants'

thoughts about the positive and negative aspects of the study, this information should greatly benefit the development of the NCS. This section also contains questions on the convenience of the interview and obstacles to participation. This section is included in all visits except for rostering, screening, the preconception telephone follow up, the OGTT visit and birth. 23 Poor maternal dental health is directly associated with preterm birth and low birth weight, and may also be an indicator of general maternal health status that can impact child development ( 9 question minimum, 10 question maximum). This section contains questions on routine cleaning and dental problems including plaque, bleeding gums, tooth ache, dentist diagnosed gingivitis or periodontitis. This section is included at the second preconception visit, any first home visit for women enrolled during pregnancy or at delivery, and is updated at the first trimester pregnancy visit.

Neighborhood questions ( 17 question minimum, 18 question maximum) are included in the interviews to measure the level of community cohesiveness and support, perceived safety and potential for violence. These variables are stressors or sources of support from preconception through childhood that may affect the well being of the mother and child. Neighborhood questions are asked during the second preconception interview or during any first home visit,

during the first trimester pregnancy visit, at the 6 month and 18 month childhood visits.

Additionally, neighborhood questions are asked at the first home visit after a woman moves.

Maternal nutrition is an important factor for a healthy pregnancy, and an important predictor for childhood eating patterns. Diet questions ( maternal: 19 question minimum, 23 question maximum) are asked three times over the course of the study ( the second preconception interview, the second pregnancy interview, and when the child is six months old). A separate self administered questionnaire ( 133 questions) distributed during the second preconception interview and again during the second trimester pregnancy visit.

Activity questions ( 10 question minimum, 28 question maximum) are asked in order to assess both potential reproductive risk factors associated with exertion and healthy lifestyle habits such as routine physical activity. This section is included during the second preconception visit, the second pregnancy visit, the 6 month, 12 month and 18 month childhood visits Mental health and financial security of the woman and her partner will have a significant impact on both maternal and household stress level ( 101 questions preconception visit; 111 questions third trimester pregnancy visit woman; 101 questions third trimester pregnancy visit partner; 112 24 questions 6 month childhood visit woman; 103 questions 6 month childhood visit partner).

Stress can increase risk for poor health outcomes and may also be related to unhealthy behaviors,

such as smoking. A mental health questionnaire is distributed during the initial home interview,

third trimester pregnancy visit and the 6 month visit for the mother and her partner to complete in privacy and mail back. This questionnaire is composed of five subsections using standard instruments to measure social support, depression, stressful life events, perceived stress and financial security; for the 6 month childhood visit there is also a subsection on child rearing support. Mental health and financial security questions are asked at the initial preconception visit, the third trimester pregnancy visit, and the 6 month childhood visit.

The child development section ( 18 questions for one month olds, 36 questions for six month olds, 43 questions for 12 month olds and 48 questions for 18 month olds) captures information about the activities and development of the child to determine whether or not they are developing normally for their age. These questions encompass age appropriate communication, gross motor, fine motor, problem solving, and personal/ social parameters. Additionally, questions about parent child activities and the mother's perception of her baby's personality are included.

This section is included in all post birth interviews.

The sleep characteristics of the child ( four questions) are included in the questionnaire to determine the presence of specific sleep related practices that may put children at increased risk for potentially adverse health outcomes, including Sudden Infant Death Syndrome ( SIDS). These questions may also offer an indicator of infant or child temperament. This section is included as part of the child development section and is included in all post birth interviews.

The child's diet section ( 28 question minimum, 33 question maximum for one month olds; 28 question minimum, 43 question maximum for six month olds; 33 question minimum, 44 question maximum for 12 and 18 month olds) section is included to determine potential confounders and risk factors associated with nutritional intake and healthy lifestyle habits. Additionally, the mother's intent to breastfeed her child ( 2 questions minimum, 3 questions maximum) is asked to determine the sources of nutritional intake the child will have. The intent section is included in 25 the third trimester visit while child diet is measured in the one, six, twelve, and eighteen month visits.

The medical history of the child ( 12 questions minimum, 16 questions maximum for one month olds; 5 question minimum, 8 questions maximum for six month olds; 7 question minimum, 17 questions maximum for 12 and 18 month olds) section is asked in order to capture any health conditions that the child may have. These health outcomes are an important indicator of potentially adverse effects of the environmental exposures the study is measuring. This section is included in all post birth interviews.

The infant safety ( 3 questions minimum, 6 questions maximum) section is asked to determine physical and behavioral risk factors experienced by the child. Car seat use, firearms, and smoke alarms use are of particular interest due to the risks posed to the health of the child and the mother. This series of questions is asked only during the 1 month visit.

The post partum depression ( 6 questions minimum, 12 questions maximum) section is asked in order to determine the mental health of the mother following delivery and whether or not the woman has sought help from medical professionals for depression related to her pregnancy or child birth. This series of questions is only asked during the one month visit.

Where appropriate if the participant's answers to questions that indicate they are engaging in behavior that is counter to the current public health understanding, the interviewer will be notified by the computer program to provide the participant with public health brochures dealing with topics such as infant safety ( car seat use), the importance of prenatal care, and infant sleeping positions. These public health materials are freely available from local health departments and will be given to the participant should their answers indicate that their behavior does not correspond to recommended practice. No other interventions are planned.

Style of Questions Most questions have a forced choice between multiple responses or two choices ( Yes, No). The number of free form questions is limited to items where the respondent's verbatim response is anticipated to be particularly useful for the study. 26 Purpose of Questions The purpose of these questions is to evaluate the feasibility and acceptability of the proposed NCS schedule of visits by assessing the subject burden associated with questionnaires administered at home visits as well as participant compliance with mail back survey instruments.

All of the questionnaire domains are expected to be included in the National Children's Study ( NCS). This Pilot Study provides an additional benefit of field testing questionnaire elements that may be used in the NCS. The NCS will examine many aspects of children's lives via home interviews and questionnaires, from the physical environment of neighborhoods and schools; to chemical exposures linked to the atmosphere, food, or water supplies; to the social and behavioral environment in which the children grow and develop. Domains were also chosen for this Pilot Study to address exposures and outcomes that are common enough to provide information to Pilot Study subjects that would relate to their own child's general growth and development.

( ii) Respondent Activities Potential respondents will be contacted via an introductory letter and informational brochure about the study about two weeks prior to either receiving a call or being visited by study staff. The interviewer will elicit verbal informed consent during this introductory screening meeting ( Instruments # 1 and # 2; 10 minutes each). The respondent need only reply to the questions asked during the screening meeting. The risks associated with this activity do not extend beyond those of daily living. Subsequent contact will include both in home and clinic visits with participants. The proposed data collection is planned to begin in the first quarter of 2006. The household screening phase of the study is expected to take approximately 4 months to complete. Recruitment and enrollment of eligible women into the study will begin concurrently with the household screening phase, and will take approximately 18 months to complete. There are three basic data collection schedules: preconception, pregnancy, and post pregnancy. 27 PRECONCEPTION VISIT SCHEDULE Eligible women enrolled prior to conception who are planning to become pregnant ( high likelihood group) will be invited to participate in a home visit approximately two weeks after screening. This first visit will take about 2.5 hours ( 75 minutes for in person interview for the woman ( Instrument # 3), 15 minutes for mail back questionnaire ( Instrument # 5), and 60 minutes for biologic and environmental sample collection and instructions, etc.). Note that the burden for environmental sample collection is calculated only when the woman's participation is necessary.

Otherwise, technicians would be performing data collection concurrently while the woman is being interviewed. Women and their husbands/ partners ( if they choose to participate) will be interviewed and asked to provide biologic samples ( 40 minutes for in person interview with the husband/ partner concurrent with the woman ( Instrument # 4), and 35 minutes for sample collection in the first visit). Study staff will collect environmental samples from the home.

Women in this group will receive pregnancy test kits and fertility monitors for their use.

Home visits that last approximately 1.5 hours will be conducted every two months ( 45 minutes for in person interview with the woman ( Instrument # 6), 30 minutes for mail back questionnaire ( Instrument # 7) after the second preconception visit only, and 15 minutes for environmental sample collection and instructions, etc.), with a 5 minute telephone call ( Instrument # 10) during the intervening month to update pregnancy status. Follow up in this group continues for a maximum of three visits or until a woman becomes pregnant ( transfers to pregnancy schedule). If the woman is not pregnant in six months, she joins the moderate likelihood group and will be followed by telephone call only. Subsequent follow up home visits at 4 and 6 months ( visit # 3 and 4) last only 45 minutes ( 30 minutes for an in person interview ( Instruments # 8, 9) and 15 minutes for biologic and environmental sample collection and instructions, etc.).

Eligible women enrolled prior to conception who have a moderate likelihood of pregnancy based on the screening questions are invited to participate in a home visit approximately two weeks after screening. The first preconception visit is identical to the one women in the high likelihood group receive. Women in this group will receive a 5 minute telephone follow up ( Instrument # 10) once every three months for a maximum of one year. If their plans change and they want to try to become pregnant, they will be invited to participate in the high likelihood group. If they become pregnant, they will be invited to participate in the pregnancy schedule of visits. 28 Women who are otherwise eligible, but not likely to become pregnant based on the screening ( low likelihood) will receive a 5 minute telephone follow up ( Instrument # 10) one year after the screening visit. If their pregnancy status or intention changes, they can move to one of the other follow up groups.

PREGNANCY VISIT SCHEDULE Women may be enrolled at any point during pregnancy. Women who join this group after participating in preconception visits will have a 1.5 hour home visit during the first trimester ( 45 minutes for in person interview for the woman ( Instrument # 11), and 45 minutes for biologic and environmental sample collection and instructions, etc.). Women and their husbands/ partners ( if they choose to participate) will be interviewed and asked to provide biologic samples ( 30 minutes for in person interview with the husband/ partner concurrent with the woman ( Instrument # 12) in the first visit). Study staff will collect environmental samples from the home. In the first trimester, women may be invited to have an oral glucose tolerance test ( 2.5 hour in subject time, no questionnaires; approximately ten percent are expected to participate). Second and third trimester clinic visits will have clinical assessments, such as ultrasound exams, collection of biologic specimens and personal interview with a take home mail back questionnaire ( each visit is 3 hours: 45 minutes for interview ( Instruments # 15, 17),

30 and 15 minutes for mail in survey ( Instruments # 16, 18 respectively), and 2 hours for biologic collection and instructions, etc.). Partners will also be asked to fill out a mail in survey 15 minutes ( Instrument # 19).

Women who come into the study already pregnant will pick up with the visit schedule appropriate for the baby's gestational age. If women are enrolled in the first trimester, they will participate in a home visit lasting 1.75 hours ( 60 minute in person interview ( Instrument # 13), 45 minute for biologic and environmental sample collection and instructions, etc.). Partners of women in their first trimester, should they choose to, will participate in a 30 minute interview ( Instrument # 14). This home visit includes the domains for " any first home basic" visit plus the first trimester home visit. Visits for the second and third trimester are the same as the preconception group. A few women may join early enough in the first trimester to also participate in the oral glucose tolerance test, but we do not anticipate that will be common.

Women enrolled in the second or third trimester will participate in those clinic visits but will not be visited in their homes until their baby is one month old.

For women who deliver at participating hospitals, we hope to collect biologic specimens and a limited amount of clinical information ( total time 26 hours for all hospital staff who may 29 not be subcontractors, etc.) In addition to the women previously enrolled, we anticipate enrolling a few women during their hospital stay after delivering their babies.

POST PREGNANCY VISIT SCHEDULE Following the birth visit, there will be 4 home visits for data collection. The visits will take place when the child is 1, 6, 12, and 18 months of age. No children will be enrolled after the hospital delivery stay. All parents and children participating in these visits were enrolled during the preconception or pregnancy visit schedules, or at the time of delivery.

1 Month Visit The first post pregnancy visit will take place in the home when the child is one month of age. The visit is estimated to take about 1 hour ( 45 minutes for in person interview ( Instrument # 22), 15 minutes for biologic and environmental sample collection and instructions, etc.).

For women enrolled after the first trimester of pregnancy or at delivery, this visit will also include the ` any first home visit" domains, and is expected to take about 1.25 hours ( 60 minutes for in person interview ( Instrument # 20), 15 minutes for sample collection), and 30 minutes for partner interview ( Instrument # 21).

6 Month Visit The second visit will take place in the home when the child is six months of age. The information collection associated with this visit is estimated to take 2 hours ( 60 minutes for inperson interview ( Instrument # 23), 15 minutes for mail in survey to be completed after the visit ( Instrument # 25), 45 minutes biologic and environmental sample collection and instructions).

The data will be collected from the mother, father/ partner, and child. The partner in person questionnaire is estimated to take 20 minutes ( Instrument # 24) and the mail in survey to take 15 minutes ( Instrument # 26).

12 Month Visit The third post pregnancy visit will take place in the home when the child is twelve months of age. The visit is estimated to take 1.5 hours ( 60 minutes for an in person interview 30 ( instrument # 27), and 30 minutes for biologic and environmental sample collection). The data will be collected from the mother and child.

18 Month Visit The final visit planned for the Pilot Study will take place when the child is 18 months of age. Questionnaire domains to be updated will be the same as those at the 6 month visit. The non interview domains will also be similar, including biologic samples of the child's nails,

saliva, and urine. The child exam will focus on physical and developmental milestones appropriate for the age group. The visit is estimated to take two hours ( 60 minutes for an inperson interview ( instrument # 28), and 60 minutes for biologic and environmental sample collection).

Relocation Interview and Event Form Should participants relocate during the course of the study and remain eligible ( moving within segment boundaries before birth of child), they will be administered a questionnaire consisting of the Home Environment and Neighborhood domains ( Instrument # 29) this is expected to take 5 minutes.

A one page Event Form ( Instrument # 30) will be given to the participants to be completed whenever a woman or her child has a non routine doctor visit, an emergency room visit, a hospital admission, a significant illness that did not result in medical attention, or other medical events. Completion of this form is anticipated to take 5 minutes.

Incentives The results of focus groups conducted across the country in populations similar to the ones here indicate that a range of incentives should be considered but should also include some cash or cash equivalent ( gift cards for department stores such as Target or Walmart, local grocery stores,

or local child focused stores such as Babies R Us) as a token of appreciation, particularly after collection of biologic specimens. Currently, a number of incentives are under consideration including cash or cash equivalent incentives associated with each sample provided, for example:

$ 25 for blood, $ 5 for urine, $ 5 for saliva, $ 20 for semen, and $ 20 for vaginal swab. 31 5. The Information Collected   Agency Activities, Collection Methodology, and Information Management 5( a) Agency Activities The Agency has a support contract in place with a private research organization whose scope of work includes the ability to conduct all aspects of this Pilot Study. The contractor's workplan will include development of the study materials and operational manuals, household enumeration and recruitment, conduct of telephone, home and clinic study visits, and to assist with the analysis. The Agency will administer the contract and, with support from the previously identified federal partners, oversee the design and conduct of the research and perform quality assurance procedures throughout the data collection.

5( b) Collection Methodology and Management Following the initial screening visit, all women enrolled into the study will be scheduled a visit with a trained interviewer to answer questions about her health, relevant background information, and information on other potential risk factors. The appointment for these women will be scheduled either during the screening visit or through a recruitment phone call. After obtaining informed consent, questionnaires will be administered in the woman's home using computer assisted interviewing ( CAI) techniques, including both computer assisted personal interviewing ( CAPI) and audio computer assisted self interviewing ( ACASI).

Once a woman is enrolled in the study, the schedule of follow up depends on her pregnancy status ( with non pregnant women stratified into three groups according to the NCS Study Plan). The schedule for follow up after delivery depends on the age of the child. A central scheduling and tracking system, with appropriate access limits in place to preserve confidentiality, will be maintained by the contractor.

Every effort will be made to minimize the burden placed on the participant by utilizing time efficient questionnaires and grouping different data collection metrics together. For instance, interview data collection may be scheduled in conjunction with environmental exposure assessment to minimize the overall impact on the participant. Furthermore, clinic and other healthcare visits will be coordinated so biologic, any necessary environmental samples, and questionnaire information will be collected in a single visit with minimal burden on the participant.

If at any point in time the participant has any questions, the participant can contact a tollfree number or ask the interviewer to respond to them. If the participant does not wish to continue with the interview at any point in time, the interviewer will end the interview. Because 32 the purpose of the Pilot Study is to understand concerns of potential participants, we will ask the participant if they are willing to indicate why they want to terminate the interview.

The contractor will assemble the data into a SAS dataset, using only an identifying code to link with the dataset already assembled from the study's previous data collection activities.

The electronic questionnaires, with unique identifiers, will be turned over to the EPA and kept on CD in the principal investigator's office in a locked cabinet. Quality assurance measures will be taken; the principal investigator may call a sample of participants to ask them about the quality of the interview experience.

5( c) Small Entity Flexibility This section does not apply because this collection does not support regulatory requirements, and small businesses will not be respondents.

5( d) Collection Schedule The proposed data collection is planned to begin in the first quarter of 2006. The household screening phase of the study is expected to take approximately 4 months to complete.

Recruitment, enrollment, and follow up of eligible women into the study will begin concurrently with the household screening phase, and will take approximately 3 years to complete. Exhibit 4 outlines the data collection schedule for women who are not pregnant at enrollment; Exhibit 5 provides the schedule for women enrolled at pregnancy or who become pregnant at some point during the preconception follow up. 33 Exhibit 4. Schedule of Preconception Visits TYPE OF CONTACT2 Month of Enrollment Period Time1 High Likelihood Moderate Likelihood Low Likelihood 1 5 Time plus 2 weeks ( Preconception # 1) H H No home visits 2 6 Time + 1 month T 3 7 Time + 2 months ( Preconception # 2) H 4 8 Time + 3 months T T 5 9 Time + 4 months ( Preconception # 3) H 6 10 Time + 5 months T 7 11 Time + 6 months ( Preconception # 4) H T 8 12 Time + 7 months 9 13 Time + 8 months 10 14 Time + 9 months T T 11 15 Time + 10 months 12 16 Time + 11 months 13 17 Time + 12 months T T T 14 18 Time + 13 months 15 18 Time + 14 months 16 18 Time + 15 months T T 17 18 Time + 16 months 1 Time is defined as the time of enrollment 2 H= home visit; T= telephone Exhibit 5. Schedule of Post conception Visits Visit time Type/ Location of Contact1 First trimester ( Pregnancy # 1) H OGTT C Second trimester ( Pregnancy # 2) C Third trimester ( Pregnancy # 3) C Birth C 1 month H 6 months H 12 months H 18 months H 1 H= Home; C= Clinical Facility/ Hospital 34 6. Estimating the Burden and Cost of the Collection 6( a) Estimating Respondent Burden Respondent burden can be organized by information collection activity ( i. e., visit or contact) and respondent type. The respondent types include women ( according to their status at enrollment), their husbands or partners, and children born to them. Burden for these study groups is totaled to estimate the entire participant burden for the Pilot Study.

The schedule for preconception visits will depend on the woman's likelihood of pregnancy, classified by the NCS Study Plan as high, moderate, and low likelihood for pregnancy. Women with a high or moderate likelihood of pregnancy will be visited in their homes within 2 weeks of their enrollment to collect interview data, biologic and environmental samples, and anthropometric measurements. After this initial home visit, the schedule for high and moderate likelihood groups will include a combination of home visits and telephone calls at varying intervals. It is estimated that 70 to 90 percent of the women in the high likelihood group will get pregnant within 6 months of enrollment; therefore, follow up for this group is most intense. The low likelihood group will not receive home visits; rather, women in this group will be asked to contact the study staff in the event that their pregnancy plans change. The only follow up with this group will be by telephone at 12 months after enrollment.

Once enrolled women become pregnant, the visit schedule will follow that defined in the NCS Study Plan. The Pilot Study will enroll more women late in pregnancy compared to the NCS Study Plan, which focuses on preconception and first trimester enrollment. These women will be folded into the NCS Visit Schedule at the appropriate time point.

Approximately 10,000 occupied households will be visited and we assume that approximately 85% ( n= 8,770) will be rostered to identify age eligible women based on our preliminary sampling estimates. As a result, we expect that approximately 4,426 women will be screened and of those, 2,657 will be enrolled in the study based on Census data for the number of age eligible women in the population. We also assume that 35 women will be enrolled at delivery and another 48 women who express interest in the study ( i. e., volunteers) will be screened and enrolled, for a total of 2,740 women. These 2,740 enrolled women are estimated to contribute 406 births over the study enrollment period, as shown in Exhibit 6 below. Estimates of enrollment rates and birth rates were adapted from the Brief on Estimated Sample Size of Women Needed to Result in 100,000 Live Births located on the NCS website at http:// www. nationalchildrensstudy. gov/ research/ analytic_ reports/ loader. cfm? url=/ commonspot/ s ecurity/ getfile. cfm& PageID= 9099 ( Pivetz, Iroz Elardo, Strauss, Rust, and Menkedick, 2004). 35 Exhibit 6. Number of Eligible Women Screened and Enrolled, and Number of Births Expected by Group Enrolled Births Group Number Screened N % N %

Pregnant at enrollment 186 121 65 108 89 High likelihood of pregnancy 256 167 65 57 34 Moderate likelihood of pregnancy 962 572 59 50 9 Low likelihood of pregnancy 3,022 1,797 59 115 6 Subtotal of women from household recruiting 4,426 2,657 60 330 12 Women at delivery N/ A 35   35 100 Volunteers 64 48 75 41 85 Total 4,490 2,740   406 15 Exhibit 7 provides estimates of the burden per respondent type by visit/ contact for screening and preconception visits. The estimated total burden by respondent and visit type is calculated by multiplying the burden estimate for each visit by the total number of participants.

The total burden by participant type is then obtained by summing over all visits. Detailed estimates provided in the Final Visit Schedule and Burden Estimates: Population based pilot study of children's environmental health in support of the National Children's Study report,

available in EPA E Docket number ORD 2005 0010, were used to calculate annualized burden estimates. Several assumptions were made in estimating the number of respondents; these are described in see Section 6( d) below.

The burden estimates for post conception visits, from the first trimester to 18 months of age, are detailed in Exhibit 8. The pregnancies resulting from the preconception group will all begin with the first trimester visit. Exhibit 8 also includes estimated burden for medical staff who will be asked to assist in biologic sample collection and clinical measurements at each of the clinic visits ( OGTT, 2nd trimester, 3rd trimester, and delivery).

To obtain the total participant burden, the burdens by participant type for preconception visits ( Exhibit 7) and post conception visits ( Exhibit 8) are combined with the burden for the household unit rostering visit and the burden for women who complete the screening but are not enrolled in the Study ( n= 1,750). The rostering visit, to identify eligible women to be screened for the Study, can be completed by any adult member of the household. Therefore, the respondent type has been specified as " Household Unit" in the table below. The total burden for each information collection activity is shown in Exhibit 9. 36 Exhibit 7. Burden Estimates for Screening and Preconception Visits Total Burden per Information Collection Activity ( Hours)

Enrolled Women Information Collection Activity High Moderate Low Pregnant, 1st Trimester Pregnant, 2nd Trimester Pregnant, 3rd Trimester Enrolled at Delivery Part ners Children Screening ( Home) * 56 191 599 19 19 19 0 0 0 Preconception # 1 ( Home) 418 1,430 0 0 0 0 0 646 0 Telephone Follow Up # 1 28 91 249 0 0 0 0 0 0 Preconception # 2 ( Home) 227 0 0 0 0 0 0 0 0 Telephone Follow Up # 2 22 85 0 0 0 0 0 0 0 Preconception # 3 ( Home) 95 0 0 0 0 0 0 0 0 Telephone Follow Up # 3 20 82 0 0 0 0 0 0 0 Preconception # 4 ( Home) 88 0 0 0 0 0 0 0 0 Telephone Follow Up # 4 18 78 0 0 0 0 0 0 0 Telephone Follow Up # 5 17 75 0 0 0 0 0 0 0 Telephone Follow Up # 6 16 0 0 0 0 0 0 0 0 Pregnancy Tests ** ( number per test) 121 48 0 0 0 0 0 0 0 Event Form 8 38 104 0 0 0 0 0 0 Moving Questions 5 16 0 0 0 0 0 0 0 Estimated Total Burden Hours 1139 2134 952 19 19 19 0 646 0 * Although technically not part of the preconception visits, burden for screening women is included in this table. Burden estimates for women who are pregnant when screened is therefore included here. ** Assume one test per month for high likelihood group, and one test total for the moderate likelihood group. *** Assume one event per year **** Assume one third of women move 37 Exhibit 8. Burden Estimates for Pregnancy and Birth/ Childhood Visits * Oral glucose tolerance test; assume 10% of women in pre pregnancy and first trimester groups will participate. ** Assumes 4 events per year per child and 1 event per year for the woman. *** Assume one third of women move during pregnancy visit and one third move during childhood visits. Total Burden per Information Collection Activity ( Hours)

Enrolled Women Information Collection Activity High Moderate Low Pregnant, 1st Trimester Pregnant, 2nd Trimester Pregnant, 3rd Trimester Enrolled at Delivery Medical staff Partners Children Any first visit: basic ( Home) 0 0 33 14 14 14 14 0 264 0 Pregnancy visit # 1 ( Home) 99 89 200 84 0 0 0 0 44 0 OGTT* ( Clinic) 18 15 33 15 0 0 0 8 0 0 Pregnancy visit # 2 ( Clinic) 189 168 381 159 168 0 0 178 0 0 Pregnancy visit # 3 ( Clinic) 180 159 363 150 159 159 0 195 0 0 Birth ( Clinic) 10 8 19 8 8 9 12 518 0 68 1 Month ( Home) 54 48 109 45 48 49 33 0 0 129 6 Months ( Home) 102 92 208 86 90 94 62 0 171 122 12 Months ( Home) 72 66 149 62 65 66 44 0 0 174 18 Months ( Home) 92 84 188 80 80 82 56 0 0 110 Event Form** 21 19 43 18 19 19 13 0 0 0 Moving Questions*** 3 3 7 3 1 1 1 0 0 0 Estimated Total Burden Hours 840 751 1,733 724 652 493 235 899 479 603 38 Exhibit 9. Estimated Respondent Burden in Hours Burden ( Hours) by Respondent Type Information Collection Activity Household Unit Women Partners Children Medical staff Total Respondent Burden ( Hours) Annual Respondent Burden ( Hours) Household Rostering 833 0 0 0 0 833 278 Screening ( Home) 0 1,486* 0 0 0 1,486 495 Preconception # 1 ( Home) 0 1,848 646 0 0 2,494 831 Telephone Follow Up # 1 0 368 0 0 0 368 123 Preconception # 2 ( Home) 0 227 0 0 0 227 76 Telephone Follow Up # 2 0 107 0 0 0 107 36 Preconception # 3 ( Home) 0 95 0 0 0 95 32 Telephone Follow Up # 3 0 102 0 0 0 102 34 Preconception # 4 ( Home) 0 88 0 0 0 88 29 Telephone Follow Up # 4 0 96 0 0 0 96 32 Telephone Follow Up # 5 0 92 0 0 0 92 31 Telephone Follow Up # 6 0 16 0 0 0 16 5 Pregnancy Tests 0 169 0 0 0 169 56 Any first visit: basic ( Home) 0 89 264 0 0 353 118 Pregnancy visit # 1 ( Home) 0 472 44 0 0 516 172 OGTT ( Clinic) 0 81 0 0 8 89 30 Pregnancy visit # 2 ( Clinic) 0 1,065 0 0 178 1,243 414 Pregnancy visit # 3 ( Clinic) 0 1,170 0 0 195 1,365 455 Birth ( Clinic) 0 74 0 68 518 660 220 1 Month ( Home) 0 386 0 129 0 515 172 6 Months ( Home) 0 734 171 122 0 1,027 342 12 Months ( Home) 0 524 0 174 0 698 233 18 Months ( Home) 0 662 0 110 0 772 257 Event Form** 0 302 0 0 0 302 101 Moving Questions*** 0 40 0 0 0 40 13 Total 833 10,293 1,125 603 899 13,753 4,585 * Includes burden for women who complete the screening but are not enrolled in the Study ( 1,750 women x 20 minutes per response = 583 total hours). ** Assumes 4 events per year per child and 1 event per year for the woman. *** Assume one third of women move during pregnancy visit and one third move during childhood visits.

Annual Respondent Burden: 4,585 hours Annual Record Keeping Burden: None 39 6( b) Respondent Costs Respondent costs have been calculated using the average hourly wage for adults determined from the Greensboro Winston Salem High Point May 2004 Metropolitan Area Occupational Employment and Wage Estimates from the Bureau of Labor Statistics1. The rate for adults ($ 16.33) is the mean hourly rate for all occupations in this area. For children, the hourly wage is estimated at $ 5.15, the minimum wage for North Carolina. For medical staff, an hourly wage of $ 50.00 was used to estimate costs, assuming that the overall burden for medical staff would be apportioned between obstetricians/ gynecologists ( with a mean hourly wage of $ 94.38) and registered nurses ( with a mean hourly wage of $ 23.40). The annual cost to respondents is calculated as shown in Exhibit 10.

1 Source: Bureau of Labor Statistics. ( May 2004). Occupational Employment Statistics ( http:// www. bls. gov/ oes/ current/ oes_ 3120. htm# b00 0000). 40 Exhibit 10. Total Estimated Burden and Costs: Screening, Preconception, Pregnancy, Birth, and Childhood Visits Information Collection Activity Total Respondent Burden ( Hours) Annual Respondent Burden ( Hours) Estimated Annual Cost Household Rostering 833 278 $ 4,540 Screening ( Home) 1,486 495 $ 8,083 Preconception # 1 ( Home) 2,494 831 $ 13,570 Telephone Follow Up # 1 368 123 $ 2,009 Preconception # 2 ( Home) 227 76 $ 1,241 Telephone Follow Up # 2 107 36 $ 588 Preconception # 3 ( Home) 95 32 $ 523 Telephone Follow Up # 3 102 34 $ 555 Preconception # 4 ( Home) 88 29 $ 474 Telephone Follow Up # 4 96 32 $ 523 Telephone Follow Up # 5 92 31 $ 506 Telephone Follow Up # 6 16 5 $ 82 Pregnancy Tests ( number per test) 169 56 $ 914 Any first visit: basic ( Home) 353 118 $ 1,927 Pregnancy visit # 1 ( Home) 515 172 $ 2,809 OGTT ( Clinic) 89 30 $ 574 Pregnancy visit # 2 ( Clinic) 1,243 414 $ 8,766 Pregnancy visit # 3 ( Clinic) 1,365 455 $ 9,621 Birth ( Clinic) 660 220 $ 9,155 1 Month ( Home) 515 172 $ 2,325 6 Months ( Home) 1,027 342 $ 5,138 12 Months ( Home) 698 233 $ 3,151 18 Months ( Home) 772 257 $ 3,792 Event Form 302 101 $ 1,644 Moving Questions 40 13 $ 218 Total 13,752 4,585 $ 82,728 Annual Respondent Cost: $ 82,728 Capital/ Start Up Cost: None Operating and Maintenance ( O& M) Cost: None 6( c) Estimating Agency Burden and Cost The Agency already has a contract in place with a private research organization whose scope of work includes the ability to conduct all aspects of the Pilot Study. These costs are included in Exhibit 12, along with hours and costs associated with the Agency activities and those of an Information Technology ( IT) contractor. Based on the 2005 GS pay schedule, EPA estimates an average hourly rate of $ 54.00 for Agency staff. To derive hourly estimates, EPA divided the annual compensation for a GS 13, Step 1 by 2,080 which is the number of hours in the Federal work year. EPA then multiplied the hourly rate by the standard government benefits multiplication factor of 1.6. 41 Exhibit 11. Agency Cost Annual Burden Annual Burden Hours Costs ($) Agency Activities Contractor IT Contractor EPA Freq Total Hours Contractor $ 100/ hour IT Contractor $ 125/ hour EPA $ 54.00/ hour Planning 2,790 1,000 1,500 1 5,290 $ 279,000 $ 125,000 $ 81,000 Field Preparations 1,860 200 372 1 2,432 $ 186,000 $ 25,000 $ 20,088 Data Collection 11,160 0 416 1 11,576 $ 1,116,000 $ 0 $ 22,464 Data Editing and Statistical Analysis 2,790 0 480 1 3,270 $ 279,000 $ 0 $ 25,920 TOTAL 18,600 1,200 2,768 1 22,568 $ 1,860,000 $ 150,000 $ 149,472 Agency Total Annual Burden: 22,568 Agency Total Annual Cost: $ 2,159,472 6( d) Estimating the Respondent Universe and Total Burden and Costs Because the data collection period for this study is expected to occur over a period of 3 years, we anticipate some respondent attrition throughout the follow up. Women who are enrolled during pregnancy or at delivery will have a different total burden depending on where in the visit schedule they begin. In addition,

women enrolled during preconception will have a different burden depending on if and when they become pregnant. A number of assumptions have been made in estimating the total respondent burden and cost described in Sections 6( a) and 6( b):

Preconception visits   The total number pregnant women in each pregnancy likelihood group is estimated from a document prepared by Battelle for the NCS, Brief on Estimated Sample Size of Women Needed to Result in 100,000 Live Births located on the NCS website at http:// www. nationalchildrensstudy. gov/ research/ analytic_ reports/ loader. cfm? url=/ commonspot/ secur ity/ getfile. cfm& PageID= 9099 ( Pivetz, Iroz Elardo, Strauss, Rust, and Menkedick, 2004).

  The distribution of time to pregnancy for the high likelihood group has been adapted from information received from NICHD as a result of a literature review performed for a study of women seeking to become pregnant.

  The distribution of time to pregnancy for the moderate likelihood group uses somewhat similar rates as the high likelihood group, but delayed by 1 month. For the low likelihood group, the number of total pregnancies was almost equally divided by time. 42   Women may move between likelihood groups throughout the enrollment period, but we have not made any estimates of these rates or the direction of movement. The assumption is that movement in and out of groups will result in similar numbers of women with infants for follow up.

  The Battelle report previously referenced assumed a 0.003% attrition rate per month; we have used a more conservative estimate of 1% per month for the preconception visits.

  The number of husband/ partner respondents has been estimated at 70% of the number of women for each applicable visit.

Post conception visits   For women enrolled during pregnancy, we have assumed that there will be a 5% attrition rate between each visit.

  For the 121 women pregnant at enrollment and the 48 volunteers, we are assuming that 1/ 3 of the women will enter at each of the three trimester visits.

  After the birth visit, we estimate a 5% attrition rate per visit.

  Finally, the women who are enrolled at delivery will begin with the birth visit, and it is estimated that there will be a 5% attrition rate for each subsequent visit.

  The number of husband/ partner respondents has been estimated at 70% of the number of women for each applicable visit.

  For purposes of estimating burden, we have assumed that half of the biologic samples in the OGTT and second and third trimester visits will be collected by clinic staff and the remaining samples will be collected by study staff.

  For the biologic samples collected at birth, we are assuming that 85% of the samples will by collected by hospital staff. Samples will be collected by contractor staff in those instances that hospitals or clinics choose not to participate in the study.

The respondent universe for each information collection activity and respondent type is provided in Exhibits 12 and 13. 43 Exhibit 12. Respondent Universe Estimates for Screening and Preconception Visits Number of Respondents per Information Collection Activity Women Information Collection Activity High Moderate Low Pregnant, 1st Trimester Pregnant, 2nd Trimester Pregnant, 3rd Trimester Enrolled at Delivery Partners Children Screening ( Home) 167 572 1,797 56 56 57 0 0 0 Preconception # 1 ( Home) 167 572 0 0 0 0 0 517 0 Telephone Follow Up # 1 167 547 1,491 0 0 0 0 0 0 Preconception # 2 ( Home) 151 0 0 0 0 0 0 0 0 Telephone Follow Up # 2 132 508 0 0 0 0 0 0 0 Preconception # 3 ( Home) 126 0 0 0 0 0 0 0 0 Telephone Follow Up # 3 120 489 0 0 0 0 0 0 0 Preconception # 4 ( Home) 117 0 0 0 0 0 0 0 0 Telephone Follow Up # 4 110 469 0 0 0 0 0 0 0 Telephone Follow Up # 5 101 450 0 0 0 0 0 0 0 Telephone Follow Up # 6 95 0 0 0 0 0 0 0 0 Pregnancy Tests* ( number per test) 1,453 572 0 0 0 0 0 0 0 Event Form** 95 450 1250 0 0 0 0 0 0 Moving Questions*** 55 189 0 0 0 0 0 0 0 * Assume one test per month for high likelihood group, and one test total for moderate likelihood group. ** Assumes 4 events per year per child and 1 event per year for the woman. *** Assume one third of women move during pregnancy visit and one third move during childhood visits. 44 Exhibit 13. Respondent Universe Estimates for Pregnancy and Birth/ Childhood Visits Number of Respondents per Information Collection Activity Women Information Collection Activity High Moderate Low Pregnant, 1st Trimester Pregnant, 2nd Trimester Pregnant, 3rd Trimester Enrolled at Delivery Medical staff * Partners Children Any first visit: basic ( Home) 0 0 133 56 56 57 33 0 211 0 Pregnancy visit # 1 ( Home) 66 59 133 56 0 0 0 0 88 0 OGTT** ( Clinic) 7 6 13 6 0 0 0 16 0 0 Pregnancy visit # 2 ( Clinic) 63 56 127 53 56 0 0 178 0 0 Pregnancy visit # 3 ( Clinic) 60 53 121 50 53 53 0 195 0 0 Birth ( Clinic) 57 50 115 48 50 51 35 345 0 406 1 Month ( Home) 54 48 109 45 48 49 33 0 0 386 6 Months ( Home) 51 46 104 43 45 47 31 0 257 367 12 Months ( Home) 48 44 99 41 43 44 29 0 0 348 18 Months ( Home) 46 42 94 40 40 41 28 0 0 331 Event Form*** 256 230 521 217 226 232 156 0 0 0 Moving Questions**** 40 35 80 33 16 16 11 0 0 0 * Medical staff respondent universe includes the total number of staff persons required to carry out required tasks on an annual basis. Estimates are for both Davidson and Forsyth Counties and include both clinic and hospital settings. ** Oral glucose tolerance test; assume ten percent of women in pre pregnancy and first trimester groups will be asked to participate. *** Assumes 4 events per year per child and 1 event per year for the woman. **** Assumes one third of women move during pregnancy visit and one third move during childhood visits.

6( e) Bottom Line Burden Hours and Costs Tables ( i) Respondent Tally: The annual respondent burden ( for all respondents and all visits) is 4,585 hours at an estimated annual cost of $ 82,728.

( ii) Agency Tally: The annual agency burden is 22,568 hours at a cost of $ 2,159,472.

( iii) Variations in the Annual Bottom Line: We do not anticipate a significant variation (> 25%) in the annual respondent reporting/ recordkeeping burden or cost over the 3 year OMB approval period. 45 6( f) Reasons for Change in Burden There is no change in the burden because this is a new request.

6( g) Burden Statement The public reporting and recordkeeping burden for this collection of information varies depending on the eligibility and pregnancy status of women at the time of enrollment. Exhibit 15 provides a summary of annual burden, in time and cost, by respondent type. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.

To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for the minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID ORD 2005 0010, which is available for which is available for public viewing at the Office of Research and Development Docket in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566 1744, and the telephone number for the Office of Research and Development Docket is ( 202) 566 1752. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to obtain a copy of the draft collection of information, submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select " search," then key in the docket ID number identified above. Also, you can send comments to the Office of Information and Regulatory Affairs,

Office of Management and Budget, 725 17th Street NW, Washington, DC 20503, Attention:

Desk Office for EPA. Please include the EPA Docket ID number ( ORD 2005 0010) and OMB control number ( TBD) in any correspondence. 46 Exhibit 14. Annual Burden by Respondent Type Type of Respondent Estimated Number of Respondents Annual Burden ( Hours) Annual Burden ( Cost)*

Household Unit 10,000 278 $ 4,540 Women Screened, Not Enrolled 1,750 194 $ 3,168 Women Screened and Enrolled High likelihood of pregnancy 167 660 $ 10,778 Moderate likelihood of pregnancy 572 962 $ 15,710 Low likelihood of pregnancy 1,797 895 $ 14,615 Pregnant at enrollment 169 642 $ 10,484 Enrolled at delivery 35 78 $ 1,274 Partners 728 375 $ 6,124 Children 406 201 $ 1,035 Medical Staff 53 300 $ 15,000 TOTAL 15,677 4,585 $ 82,728 * Burden hours are multiplied by the following rates: $ 16.33 for women and their partners, $ 5.15 for children, and $ 50.00 for medical staff. Source: Greensboro Winston Salem High Point May 2004 Metropolitan Area Occupational Employment and Wage Estimates from the Bureau of Labor Statistics ( http:// www. bls. gov/ oes/ current/ oes_ 3120. htm# b00 0000). 47 Part B. Required Items for Information Collections Involving Statistical Sampling 1. Survey Objectives, Key Variables, and Other Preliminaries 1( a) Survey Objectives The goal of the NCS is to improve the health and well being of children through the examination of the effects of environmental influences on the health and development of more than 100,000 children across the United States, following them from before birth until age 21. To successfully achieve this ambitious goal, careful planning must be performed to ensure that the proposed protocols and measurements collected will be amenable to the study participants and collaborators, while maintaining scientific validity. The Pilot Study will provide an opportunity to field test these protocols and measures including sampling strategies, recruitment and retention, and specific measurement methods and procedures that are proposed for the NCS. The Pilot Study will serve as a platform for validation studies to compare the performance of alternative sampling, recruitment, and data collection methodologies and to estimate response rates and study costs, as well as to estimate and ideally lower, the burden on future NCS participants. The Pilot Study also will provide the platform for testing additional NCS protocols that will be developed over the anticipated 21 year course of the NCS ( e. g., protocols for collection of data at the 5 year follow up or for collection of supplemental data for a case cohort substudy of asthmatic and non asthmatic children).

Some of the questions to be answered by the Pilot Study are the following:

1. Is a household survey a feasible method ( considering operational feasibility, study costs, and response rates) for recruiting women and infants for a complex longitudinal study?

2. Do commercially available postal mailing lists provide a more efficient method with sufficient coverage for preparing a sampling frame of housing units in a specified area compared to the standard method of counting and listing?

3. What ranges of response rates can be expected for the various stages of data collection planned for the NCS?

4. What field interviewing techniques will be most effective and efficient for gaining cooperation from women who are eligible to participate in the study ( e. g., how many attempts should be made to contact sample housing units and should advance letters be sent to sample housing units)? 48 5. Will racial/ ethnic, socioeconomic or urban/ rural characteristics of the study areas pose unique challenges for recruiting and retaining participants?

6. Will the types of local medical systems pose different challenges for gaining their cooperation in the study?

7. Will the use of Census areas or school catchment areas to define the study areas have an effect on community engagement activities and participant retention?

8. To what extent is data analysis compromised by environmental samples collected by less highly trained individuals?

1( b) Key Variables Since the primary goals of the Pilot Study are to test various data collection methods, the key variables to be analyzed upon the completion of the study are acceptability of the study protocol, response rates and other measures of data quality. Calculating unit response rates for various subgroups within and across the study areas will require tracking of each housing unit listed in the sampling frames and each eligible woman identified in the household rosters of responding households. Status codes will be assigned to each case ( housing unit or woman)

during the field data collection stages to track whether the case is eligible, participating, or in progress. Upon completion of the data collection activities, the status codes will be finalized and can then be used to calculate the appropriate response rates. In addition, item response rates and data quality flags will be analyzed to determine the success of the protocols for collection of usable data.

1( c) Statistical Approach The current study plan for the NCS calls for a probability based selection of households to recruit women to participate in the study. In order to provide useful information for the implementation of the NCS, the Pilot Study needs to emulate certain aspects of the NCS study design. Since the goals of the Pilot Study do not involve the analysis of outcomes to make inferences about a specific target population, but rather emphasizes the testing of various data collection methods, it was not deemed necessary to emulate the statistical methods planned for the selection of study locations and study areas ( in which counties are area segments). However,

to make informative conclusions regarding the anticipated success of the recruitment and retention procedures planned for the NCS, a range of study areas were selected ( urban, rural,

etc.). Women and children will be recruited from these study areas using the household interviewing procedures that are planned for the NCS. Some additional recruitment through hospitals and medical providers also is planned to supplement the household sample and to test the feasibility of these alternative recruitment procedures. Women will be eligible for 49 recruitment only if they reside in the sampled study areas at the time of delivery. Household recruitment will be performed for a census of all households in the selected areas.

1( d) Feasibility The Pilot Study is a feasibility study of potential data collection methods for the NCS.

Under the current schedule, the Vanguard centers of the NCS are due to start data collection in June, 2007. Provided the Pilot Study starts the initial recruitment phase of data collection in early 2006, the rostering of households and screening and enrollment of eligible women for the Pilot Study will be completed in sufficient time to allow for modifications to the NCS study plan and protocols prior to the start of data collection for the Vanguard centers. As subsequent stages of the Pilot Study data collection are completed, the results of the data collection activities will inform the ICC of any necessary modifications to the corresponding NCS study protocols prior to the implementation of those protocols in the field.

2. Survey Design 2( a) Target Population and Coverage The goals of the Pilot Study are to test various data collection methodologies in preparation for the NCS rather than to make analytical inferences about a particular population.

To meet the goals of the study, study locations and study areas have been purposively chosen to test the methodologies on areas with different population characteristics.

In an effort to control costs, the two study locations for the Pilot Study needed to be in close proximity to Research Triangle Park, NC, to enable the project staff to make occasional trips to the study locations to observe study activities. Data collection activities in urban areas may pose different challenges than in rural areas, so the two study locations needed to have urban or rural areas in which the study could be concentrated. Another important consideration was to choose study locations that would not have a lot of overlap with any of the seven NC counties which have been selected to participate in the NCS in order to avoid confusion among community members and medical staff between the Pilot Study and the NCS. The seven counties selected for the NCS are:

  Buncombe County   Burke County   Cumberland County   Duplin County   Durham County   Gaston County 50   Rockingham County.

After considering the characteristics and locations of all counties within approximately a 100 mile radius of Research Triangle Park, NC, Davidson and Forsyth counties were chosen as the most optimal study locations for the Pilot Study. Davidson County is a predominantly rural area, while Forsyth County contains the city of Winston Salem, one of the larger cities in NC.

The two counties are adjacent to one another.

The NCS study locations in closest proximity to Forsyth and Davidson counties are Durham and Rockingham counties. Exhibit 15 shows the birth locations for births that occurred in 2003 by the mother= s county of residence for Davidson, Forsyth, counties. The small number of births that may occur in NCS counties to mothers who live in Pilot Study counties and vice versa, combined with a 2 year lag between the start of the Pilot Study data collection and NCS data collection, will result in very few, if any, births that overlap between the two studies in the same time frame.

While trying to avoid as much overlap in births as possible between the NCS and Pilot Study locations, it is advantageous to choose two study locations for the Pilot Study that would have a significant overlap in births across the study locations so that fewer medical facilities would need to be recruited in order to cover the facilities where the majority of the births occur for residents of the study locations. Less than one percent of the births in 2003 to mothers who lived in Forsyth County occurred in Davidson County, however more than 17% of the births to mothers who lived in Davidson County occurred in Forsyth County. 51 Exhibit 15. Births in 2003 by Mother's County of Residence County of Birth Location Number of Births Percent of Births Mothers Residing in Pilot Study Locations County of Residence: Davidson Davidson 1,121 57.8%

Guilford 400 20.6%

Forsyth 342 17.6%

Rowan 36 1.9%

Randolph 11 0.6%

Cabarrus 7 0.4%

Mecklenberg 5 0.3%

Stanly 4 0.2%

Wake 3 0.2%

Durham 2 0.1%

Out of State 2 0.1%

Columbus 1 0.1%

Gaston 1 0.1%

Iredell 1 0.1%

Moore 1 0.1%

Orange 1 0.1%

Rockingham 1 0.1%

Scotland 1 0.1%

County of Residence: Forsyth Forsyth 4,300 92.9%

Guilford 269 5.8%

Davidson 18 0.4%

Out of State 11 0.2%

Surry 6 0.1%

Iredell 5 0.1%

Mecklenberg 5 0.1%

Orange 5 0.1%

Durham 2 0.0%

Wake 2 0.0%

Alamance 1 0.0%

Buncombe 1 0.0%

Carteret 1 0.0%

Catawba 1 0.0%

Rowan 1 0.0% 52 In order to control field data collection costs associated with conducting a household survey, two well defined areas were chosen within each study location. One of the goals of the Pilot Study is to test the effects of choosing study areas defined by school catchment areas as contrasted with the traditional use of Census areas. To evaluate the effects of the different boundary definitions, one Census area and one school catchment area were chosen within each study location. In Davidson County, the Census area was chosen to be in the city of Lexington and the school area was chosen in a very rural area in northwest Davidson County. With a population of less than 20,000 people, Lexington is representative of a small town. The rural elementary school catchment area has similar characteristics as many rural areas in the mid west United States. In Forsyth County, both the Census and school catchment areas were chosen in the central part of Winston Salem. Both areas are similar to urban areas in U. S. cities and have been chosen with similar demographic and socioeconomic characteristics to facilitate comparisons between the Census and school catchment areas.

As a result of the purposive selection of the study locations and their associated study areas, the target population for the Pilot Study will be all women who reside in the study areas who are eligible for participation in the study. The coverage will be the same as the target population. The eligibility criteria for women to participate in the Pilot Study are as follows:

  Woman who are at least 18 years of age.

  Women who reside in a study area.

  Women with no plans to move out of the study area before delivery ( if pregnant at the time of enrollment).

  Women and their partners are not surgically sterile.

2( b) Sample Design i) Sampling Frame The sampling frame for the Pilot Study will be a list of all housing units in the designated study areas in Davidson and Forsyth Counties, NC. The sampling frames for each study area will be compiled using two methods:

  Counting and listing   Residential postal address mailing lists.

To evaluate the costs and coverage of each of the household sampling frame construction methods, we expect to construct the sampling frame for half of each study area using counting 53 and listing methods and the other half of each study area using commercially available residential postal address mailing lists. Quality assurance checks will be incorporated into the sampling frame construction procedures in order to identify housing units missing from either source.

ii) Sample Size For the Pilot Study, a census of all eligible women in the designated study areas will be implemented. This strategy will provide NCS planners information about feasibility issues in undertaking a census approach. Each of the chosen study areas is estimated to contain between 2,000 and 3,000 occupied housing units, for a total of approximately 10,000 occupied housing units in which rostering and screening activities will be attempted. Data from the 2000 Census and 2000 Public Use Microdata Sample ( PUMS) indicate that approximately 50% of households will contain a woman of child bearing age ( 18 to 44 years old). Based on assumed response rates and tables of estimated pregnancy rates by age groups and likelihood of pregnancy in Brief on Estimated Sample Size of Women Needed to Result in 100,000 Live Births located on the NCS website at http:// www. nationalchildrensstudy. gov/ research/ analytic_ reports/ loader. cfm? url=/ commonspot/ s ecurity/ getfile. cfm& PageID= 9099 ( Pivetz, Iroz Elardo, Strauss, Rust, and Menkedick, 2004)

prepared for the NCS, we estimate that approximately 2,740 women will enroll in the study.

From the women who enroll in the study, we estimate that approximately 406 children will be born within the monitored time frame and enrolled in the study with their mothers.

iii) Stratification Variables No stratification variables will be used in the rostering of all households in the study areas or in the screening of eligible women within the rostered households. After completing the screening questionnaire, each woman participating in the Pilot Study will be enrolled into one of the following four strata, as defined in the study plan for the NCS:

  Currently pregnant   High likelihood of pregnancy   Moderate likelihood of pregnancy   Low likelihood of pregnancy.

Women who indicate at the time of completing the screening questionnaire that they are pregnant will be assigned to the " currently pregnant" group. Women who report in the screening questionnaire that they are planning on becoming pregnant will be assigned to the high likelihood group. Women of child bearing age ( 18 to 44 years old) who report in the screening 54 questionnaire that they are sexually active, are not planning on becoming pregnant and are using either no contraception or using a contraceptive method with at least a 10% known failure rate will be assigned to the moderate likelihood group. Women of child bearing age who report in the screening questionnaire that they currently are not sexually active or are sexually active and using a contraceptive method with a less than 10% known failure rate will be assigned to the low likelihood group. As described in Part A ( 4a), the stratum assignments of women enrolled in the study by likelihood of pregnancy will determine the type and frequency of subsequent data collection activities.

iv) Sampling Method Since the Pilot Study sample design involves a census of all households and all eligible women in the designated study areas, no sampling methods will be used in the implementation of the study.

v) Multi Stage Sampling Even though no samples will be selected in the implementation of the study, two stages of activities will be performed to obtain a census of all eligible women in the designated study areas. The first stage consists of attempting to roster every household in the study areas. Once a household is rostered, each woman meeting the preliminary eligibility criteria listed in Section Part B will be screened for enrollment in the study and assigned to her corresponding likelihoodof pregnancy group.

2( c) Precision Requirements i) Precision Targets Since the goals of the Pilot Study primarily focus on the testing of various data collection methods, precision targets are displayed with respect to detectable differences in response rates calculated for various subgroups within and across the designated study areas. Exhibit 16 through Exhibit 18 presents estimated power to detect differences in response rates between two subgroups.

Exhibit 16 presents power estimates for comparing screening response rates between two subgroups of occupied housing units. Since the total estimated number of occupied housing units in the study is approximately 10,000, Exhibit 18 shows equal sample sizes that total 5,000 and 10,000 housing units. The total sample size of 10,000 housing units would be equivalent to comparing response rates between Davidson and Forsyth counties, while the total sample size of 5,000 housing units would be equivalent to comparing response rates between the two study 55 areas within Forsyth County. For example, if we wanted to compare response rates between the two study areas in Forsyth county, we would want to look at the scenario in Exhibit 16 that shows sample sizes for group 1 and group 2 of 2,500 each, producing a total sample size of 5,000 housing units ( the estimated number of housing units in the Forsyth county study areas. If the response rate of the school catchment study area ( group 1) is 50%, we will have sufficient power in the study to detect at least a 5% difference in a comparison of response rates between the school catchment study area and the Census study area.

Exhibit 17 presents power estimates for comparing enrollment rates between two subgroups of women who are identified as eligible for the study. Since the total estimated number of eligible women in the study is approximately 4,400, Exhibit 17 shows equal samples sizes that total 2,200 and 4,400 women.

Exhibit 18 presents power estimates for comparing enrollment rates between two subgroups of women who are enrolled in the study and give birth to a live infant during the enrollment period. Since the total estimated number of eligible women in the study is approximately 415,

Exhibit 18 shows equal samples sizes that total 208 and 416 women. In the sample size scenarios provided, there will be sufficient power to detect at least 10% differences between response rates of chosen subgroups of occupied housing units or eligible women in the Pilot Study and sufficient power to detect at least 20% differences between response rates of women who give birth to eligible newborns. 56 Exhibit 16. Estimated Power to Compare Screening Response Rates between Two Equal Subgroups of Housing Units Sample Size Group 1 Sample Size Group 2 Response Rate Group 1 Response Rate Group 2 Difference of Response Rates Power 2,500 2,500 0.40 0.45 0.05 94.9%

2,500 2,500 0.40 0.50 0.10 100.0%

2,500 2,500 0.40 0.60 0.20 100.0%

2,500 2,500 0.50 0.55 0.05 94.3%

2,500 2,500 0.50 0.60 0.10 100.0%

2,500 2,500 0.50 0.70 0.20 100.0%

2,500 2,500 0.60 0.65 0.05 95.3%

2,500 2,500 0.60 0.70 0.10 100.0%

2,500 2,500 0.60 0.80 0.20 100.0%

2,500 2,500 0.70 0.75 0.05 97.4%

2,500 2,500 0.70 0.80 0.10 100.0%

2,500 2,500 0.70 0.90 0.20 100.0%

2,500 2,500 0.80 0.85 0.05 99.5%

2,500 2,500 0.80 0.90 0.10 100.0%

2,500 2,500 0.80 1.00 0.20 100.0%

2,500 2,500 0.40 0.45 0.05 94.9%

5,000 5,000 0.40 0.45 0.05 99.9%

5,000 5,000 0.40 0.50 0.10 100.0%

5,000 5,000 0.40 0.60 0.20 100.0%

5,000 5,000 0.50 0.55 0.05 99.9%

5,000 5,000 0.50 0.60 0.10 100.0%

5,000 5,000 0.50 0.70 0.20 100.0%

5,000 5,000 0.60 0.65 0.05 99.9%

5,000 5,000 0.60 0.70 0.10 100.0%

5,000 5,000 0.60 0.80 0.20 100.0%

5,000 5,000 0.70 0.75 0.05 100.0%

5,000 5,000 0.70 0.80 0.10 100.0%

5,000 5,000 0.70 0.90 0.20 100.0%

5,000 5,000 0.80 0.85 0.05 100.0%

5,000 5,000 0.80 0.90 0.10 100.0%

5,000 5,000 0.80 1.00 0.20 100.0% 57 Exhibit 17. Estimated Power to Compare Enrollment Rates between Two Equal Subgroups of Women Sample Size Group 1 Sample Size Group 2 Response Rate Group 1 Response Rate Group 2 Difference of Response Rates Power 1,100 1,100 0.40 0.45 0.05 66.7%

1,100 1,100 0.40 0.50 0.10 99.7%

1,100 1,100 0.40 0.60 0.20 100.0%

1,100 1,100 0.50 0.55 0.05 65.0%

1,100 1,100 0.50 0.60 0.10 99.7%

1,100 1,100 0.50 0.70 0.20 100.0%

1,100 1,100 0.60 0.65 0.05 67.0%

1,100 1,100 0.60 0.70 0.10 99.8%

1,100 1,100 0.60 0.80 0.20 100.0%

1,100 1,100 0.70 0.75 0.05 73.1%

1,100 1,100 0.70 0.80 0.10 100.0%

1,100 1,100 0.70 0.90 0.20 100.0%

1,100 1,100 0.80 0.85 0.05 84.7%

1,100 1,100 0.80 0.90 0.10 100.0%

2,200 2,200 0.40 0.45 0.05 92.1%

2,200 2,200 0.40 0.50 0.10 100.0%

2,200 2,200 0.40 0.60 0.20 100.0%

2,200 2,200 0.50 0.55 0.05 91.3%

2,200 2,200 0.50 0.60 0.10 100.0%

2,200 2,200 0.50 0.70 0.20 100.0%

2,200 2,200 0.60 0.65 0.05 92.6%

2,200 2,200 0.60 0.70 0.10 100.0%

2,200 2,200 0.60 0.80 0.20 100.0%

2,200 2,200 0.70 0.75 0.05 95.6%

2,200 2,200 0.70 0.80 0.10 100.0%

2,200 2,200 0.70 0.90 0.20 100.0%

2,200 2,200 0.80 0.85 0.05 98.9%

2,200 2,200 0.80 0.90 0.10 100.0%

2,200 2,200 0.80 1.00 0.20 100.0% 58 Exhibit 18. Estimated Power to Compare Newborn Enrollment Rates between Two Equal Subgroups of Women Giving Birth During the Study Sample Size Group 1 Sample Size Group 2 Response Rate Group 1 Response Rate Group 2 Difference of Response Rates Power 104 104 0.40 0.45 0.05 11.6%

104 104 0.40 0.50 0.10 31.4%

104 104 0.40 0.60 0.20 83.6%

104 104 0.50 0.55 0.05 11.0%

104 104 0.50 0.60 0.10 30.0%

104 104 0.50 0.70 0.20 83.1%

104 104 0.60 0.65 0.05 11.0%

104 104 0.60 0.70 0.10 30.6%

208 208 0.40 0.45 0.05 18.2%

208 208 0.40 0.50 0.10 54.7%

208 208 0.40 0.60 0.20 98.6%

208 208 0.50 0.55 0.05 17.4%

208 208 0.50 0.60 0.10 53.1%

208 208 0.50 0.70 0.20 98.6%

208 208 0.60 0.65 0.05 17.7%

208 208 0.60 0.70 0.10 54.9%

208 208 0.60 0.80 0.20 99.2%

208 208 0.70 0.75 0.05 19.2%

208 208 0.70 0.80 0.10 61.0%

208 208 0.70 0.90 0.20 99.8%

208 208 0.80 0.85 0.05 23.5%

208 208 0.80 0.90 0.10 74.7%

208 208 0.80 1.00 0.20 100.0%

ii) Nonsampling Error One of the goals of the Pilot Study is to evaluate the potential for nonresponse bias in the NCS. First, the coverage of two alternative sources of household sampling frames   commercially available postal address lists versus standard field counting and listing procedures   will be evaluated regarding their coverage of all occupied housing units in study areas. Second,

alternative household contacting and recruitment protocols will be evaluated regarding cost 59 effectiveness for controlling nonresponse bias. Finally, the extent to which data analysis is compromised by environmental samples collected by less highly trained individuals will be evaluated.

3. Pretests and Pilot Tests Prior to the Pilot Study, the questionnaires will be pretested for consistency, timing,

content and translation of the materials using no more than 9 individuals per questionnaire by an EPA contractor with expertise in this area.

4. Collection Methods and Follow Up 4( a) Collection Methods Advance Mailing: An advance mailing will be sent to all households in the study area to inform the households that they will be contacted about the study. The advance letter will include information about the Pilot Study, community organizations that are supporting the study and the toll free number to call to volunteer for the study. Also enclosed with the advance letter will be a token incentive ( refrigerator magnet or hangtag with the study name and toll free number). Letters sent to sample households in advance of an interviewer's visit has shown to generally increase the willingness of the household to participate and to increase the confidence of the interviewers who are trying to gain the household's cooperation ( Groves and Couper,

1998). Advance letters are sent in order to alert sample households that an interviewer will be coming to their homes and the letters seek to convey the sponsorship, purpose, and legitimacy of the study. Sometimes the advance letters include a prepaid monetary incentive or small gift which has shown to be effective in increasing cooperation rates. Groves and Couper discuss the idea of reciprocation as it relates to prepaid incentives where by offering someone a " gift" in advance, the householder will feel some obligation to return the favor ( i. e., participate in the survey).

Household Rostering and Screening: Approximately 1 to 2 weeks after the advance mailing, field interviewers will begin rostering and screening the study areas for eligible participants. Each field interviewer ( FI) will be provided with a list of all eligible residential housing units within their assigned portion of the selected area. Staff will visit each listed household to complete a roster of all people who currently reside in the household. The FI will follow prescribed scripts for the rostering visits. The roster will include name, gender, and age as of the start of recruitment of any females living in the household. After the FI completes the household roster, any age eligible females will be flagged for screening. If an age eligible 60 woman is at home, the FI may conduct the screening interview. The screening interview will include data on basic demographic characteristics and current pregnancy status. Non pregnant age eligible women will be asked a series of questions to determine their likelihood of pregnancy status. If the woman is eligible for the study, then the FI will make an appointment for the enrollment interview and consent process. The FI will leave an interview appointment card,

reminding the respondent of the agreed upon interview time and providing a phone number for any rescheduling needs. The respondents will also be reminded to gather any necessary information ( such as prescription medicines, etc.) prior to the interview to save time during the interview.

If an age eligible woman refuses to be screened, the FI will be trained to accept the refusal in a positive manner to avoid creating an adversarial relationship and precluding future opportunities for conversion.

If any age eligible person is not at home, the FI will ask for the best time to contact the person and will ask for a telephone number. The FI will also leave study material and the tollfree number for any age eligible sample member to call to schedule a screening appointment.

Data Collection Activities. Women and their partners in the sample households who agree to complete the screener questionnaire will be assigned to one of the following categories:

  Currently pregnant   At high likelihood of pregnancy   At moderate likelihood of pregnancy   At low likelihood of pregnancy.

Even though it is unlikely that many women in the moderate and low likelihood

ofpregnancy groups will have a child enrolled in the study within an 18 month period, we will recruit these women for the study to test the recruitment rates and follow up procedures for the NCS. More frequent follow ups than once a year may be needed to enroll the women from the low likelihood of pregnancy groups because the NCS needs to recruit them during their first trimester, if they become pregnant.

The questionnaire and interview methods are designed to retain respondents' interest,

ensure confidentiality, and maximize the validity of responses. The sensitive portions of the interview will be self administered via ACASI so that the interviewers will not know respondents' answers. ACASI enables respondents to complete the questions privately by either 61 listening to them using an audio headset or reading them on the computer screen, and then entering their own responses directly into the computer. This method maximizes respondent privacy and confidentiality.

The bulk of the information gathered will be from questionnaires. However,

environmental exposure information will also be collected via environmental samples in and around the participants' household. At various points in time, air, dust, water and soil samples will be collected using standardized protocols. Additionally, biospecimens will be collected at regularly scheduled visits. Information will also be collected from the father/ partner ( if available and agreed to participate) and also from the infant.

4( b) Survey Response and Follow Up Our ability to gain the cooperation of potential respondents is key to the success of this endeavor. Based on information obtained from focus groups and external reports ( Pivetz et. al.,

2004), it is anticipated that the response rate for women willing to participate in the study will be around 65%. These estimates are also reflected in the response rate estimates of the statistical power calculations presented in Exhibits 17 19.

The study design and enrollment procedures were created in order to make participation as easy and non burdensome for sample members as possible. Our FIs will have flexible schedules so as to be able to set up appointments at dates and times that are most convenient for the sample household member. Most interviews will be conducted in the sample member's home. To reduce respondent burden associated with collecting biospecimen samples, we will make every effort to conduct clinic visits in conjunction with the respondents' regularly scheduled doctor appointments. Our FIs are trained to stress the importance of the project and the commitment EPA has to respondent confidentiality. The proposed per sample incentive structure using token amounts of cash or cash equivalents ( gift cards to grocery stores, etc.) will be offered to compensate participants for their time and effort. Nonmonetary incentives ( e. g.,

refrigerator magnets, calendars, public health education materials) will also be offered to participants. As an additional benefit, participants will be provided with results from their clinical and environmental measurements.

5. Analyzing and Reporting Survey Results 5( a) Data Preparation Due to the extensive use of CAI techniques on all questionnaire elements, data entry will be minimal. Information collected from the clinics, environmental sampling measures, and 62 respondent self administered PAPI questionnaires will be captured via machine scanned forms,

or double data entered ( if non scannable hardcopy forms are used for some materials). Specially designed software will be used to ensure that out of range and implausible values are flagged.

Inconsistencies also will be investigated and resolved to the extent feasible.

5( b) Analysis Since the primary goals of the Pilot Study focus on the testing of various data collection methods, the analysis of the Pilot Study data will center on the calculation of response rates for subgroups within and across the designated study areas. Comparisons of response rates by subgroups will be calculated using difference of proportions tests for two populations with large sample sizes ( i. e., sample size of each subgroup at least 30) and assessed for statistical significance in comparing the test statistic to a standard normal distribution. If the comparisons of response rates for two different subgroups involve sample sizes for each group that are less than 30, the test statistic for the difference of the response rates will be compared to a Student's t distribution with appropriate degrees of freedom.

5( c) Reporting Results Databases without individually identifiable information will be available to EPA study personnel. Because the purpose of the pilot study is to provide both quantitative and qualitative results to inform the NCS, databases will include questionnaire data, measures from environmental and biologic samples, and variables intended to qualitatively measure successful or unsuccessful data collection attempts. A report analyzing the findings and the results of the Pilot Study will be developed, reported to EPA, and made available to the NCS Program Office and the NCS Steering Committee through a presentation at a public meeting. Upon approval by EPA and NCS planners, it is anticipated that reports will be posted on the NCS web site.

Reports will provide only aggregate data, and no individual identifiers will be included. We anticipate one or more papers related to the Pilot Study and its implications to the NCS will be prepared and submitted to peer reviewed, relevant scientific journals. 63 Appendix A: Copy of 60 Day Federal Register Notice ( FR) and Supporting Documentation 1. Copy of the FR Used To Solicit Public Comments ( a) Copy of 60 day FR 64 65 66 67 68 69 70 71 72 73 74 75 ( b) Summary of Comments and Actions Taken in Response to the Comments 76 77 78 2. Draft of the 30 Day FRN ENVIRONMENTAL PROTECTION AGENCY ( EPA) ORD 2005 0010, FRL Agency Information Collection Activities: Proposed Collection; Comment Request;

Population based pilot study of children's environmental health in support of the National Children's Study, EPA ICR Number 2187.01. AGENCY: Environmental Protection Agency ACTION: Notice.

SUMMARY: In compliance with the Paperwork Reduction Act ( 44 U. S. C. 3501 et seq.), this document announces that an Information Collection Request ( ICR) has been forwarded to the Office of Management and Budget ( OMB) for review and approval. This is a request for a new collection. This ICR describes the nature of the information collection and its estimated burden and cost.

DATES: Comments must be submitted on or before [ INSERT DATE 30 DAYS AFTER PUBLICATION IN THE FEDERAL REGISTER]. ADDRESSES: Submit your comments, referencing docket ID number ORD 2005 0010, to EPA online using EDOCKET ( our preferred method), by email to oei. docket@ epa. gov, or by mail to: EPA Docket Center, Environmental Protection Agency, Office of Environmental Information Docket, Mail Code 28221T, 1200 Pennsylvania Ave., NW, Washington, DC 20460.

FOR FURTHER INFORMATION CONTACT: Susan Auby, Environmental Protection Agency, Office of Information Collection, Office of Environmental Information, 1200 Pennsylvania Ave., NW, Mail Code 28221T, Washington, DC 20460; telephone number: ( 202)

566 1672; fax number: ( 202) 566 1753; email address: auby. susan@ epa. gov.

SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB for review and approval according to procedures prescribed in 5 CFR 1320.12. On April 12, 2005 ( 70 FR 19076), EPA sought comments on this ICR pursuant to 5 CFR 1320.8( d). EPA received one comment and has addressed the comment received.

EPA has established a public docket for this ICR under Docket ID number ORD 2005 0010, which is available for public viewing at the Office of Research and Development Docket in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW,

Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566 1744, and the telephone number for the Office of Research and Development Docket is ( 202) 566 1752. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to obtain a copy of the 79 draft collection of information, submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select " search," then key in the docket ID number identified above.

Any comments related to this ICR should be submitted to EPA within 30 days of this notice.