The National Children's Study, Vanguard (Pilot) Study; Submission for OMB Review; 30-Day Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

The National Children's Study, Vanguard (Pilot) Study; Submission for OMB Review; 30-Day Comment Request

SUMMARY:

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the

Federal Register

on August 23, 2013, page 52548 and allowed 60-days for public comment. Two public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The Eunice Kennedy Shriver, National Institute of Child Health and Human Development (NICHD), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

Direct Comments to OMB:

Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs,

OIRA_submission@omb.eop.gov

or by fax to 202-395-6974, Attention: Desk Officer for NIH.

Comment Due Date:

Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.

FOR FURTHER INFORMATION CONTACT:

To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Dr. Sarah L. Glavin, Deputy Director, Office of Science Policy, Analysis and Communication, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, 31 Center Drive, Room 2A18, Bethesda, Maryland 20892, or call a non-toll free number (301) 496-7898 or Email your request, including your address to

glavins@mail.nih.gov.

Formal requests for additional plans and instruments must be requested in writing.

Proposed Collection:

The National Children's Study, Vanguard (Pilot) Study, 0925-0593, Expiration 8/31/2014—Revision, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH).

Need and Use of Information Collection:

The purpose of this request is to continue data collection activities for the NCS Vanguard Study and receive a renewal of the Vanguard Study clearance. The NCS also proposes the initiation of a new enrollment cohort, the addition of new Study visits, revisions to existing Study visits, and the initiation of methodological substudies. The NCS Vanguard Study is a prospective, longitudinal pilot study of child health and development that will inform the design of the Main Study of the National Children's Study.

Background:

The National Children's Study is a prospective, national longitudinal study of the interaction between environment, genetics on child health, and development. The Study defines “environment” broadly, taking a number of natural and man-made environmental, biological, genetic, and psychosocial factors into account. Findings from the Study will be made available as the research progresses, making potential benefits known to the public as soon as possible. The National Children's Study (NCS) has several components, including a pilot or Vanguard Study, and a Main Study to collect exposure and outcome data.

The NCS Vanguard Study continues to follow the children and families enrolled in the Vanguard Study, conducting Study visits in participants' homes and over the telephone. Data Collection visits may include the administration of questionnaires, neurodevelopmental assessments, physical measures, and the collection of biospecimens and environmental measures. The Vanguard Study has yielded valuable data and field experience related to participant recruitment, the conduct of Study assessments, and operational requirements associated with NCS infrastructure and field efforts. The purpose of the proposed data collection is to obtain further operational and performance data on processes and administration Study visit measures.

Research Questions:

The primary research goal is to systematically pilot additional study visit measures and collections for scientific robustness, burden to participants and study infrastructure, and cost for use in the Vanguard (Pilot) Study and to inform the Main Study. A secondary goal is to increase enrollment in the Vanguard Study through the identification of subsequent pregnancies among enrolled women.

Methods:

The NCS Vanguard Study data collection schedule currently

includes pre-pregnancy, pregnancy, and birth periods, as well as post-natal collection points at defined intervals between 3 and 30 months. This request extends the collection of data about the children in the Vanguard cohort through 60 months of age, with home visits scheduled for children 36, 48, and 60 months of age. Two intervening remote (phone or internet) survey data collections are proposed as well. We propose to add or modify the selected measures below to address analytic goals of assessing feasibility, acceptability, and cost of specific study visit measures.

Enrollment of Sibling Birth Cohort:

We will enroll approximately 1,000 sibling births identified among currently enrolled women. Following new pregnancies will allow us to pilot the collection of biospecimens, environmental samples, and standardized neurodevelopmental assessments on sufficient numbers of participants to understand what activities are feasible in specific settings, participants' willingness to complete requested measures, and whether measures are useful and scalable. Participants will be administered the same protocol as approved for the NCS Vanguard Study by the Office of Information and Regulatory Affairs within the Office of Management and Budget, including the collection of environmental samples, biospecimens and physical measurements during pre-pregnancy and pre- and post-natal visits. Those who report that they are trying to conceive will be initially administered the protocols approved for preconception data collection. Others who self-report a pregnancy at a later time will receive pregnancy visit instrumentation and collections.

Supplemental Information Collections

Core Questionnaire:

We propose a revised core questionnaire containing key variables and designed to collect core data at every study visit contact from the time that the enrolled child is 6 months of age to the time the child is 5 years of age.

Age-Specific Modular Questionnaires:

At each Study visit, participants will be administered brief questionnaire modules that include measures relevant to the specific age of the enrolled child.

Biospecimen Collections:

Microbiome swabs will be collected from the biological mother at birth from the vagina, mouth, and rectum and at 6, 24, and 48- month visits from the nasal cavity, mouth, and rectum. Microbiome swabs will also be collected from NCS children from the nasal cavity, mouth, and rectum at 6, 24, and 48-month visits. Shed deciduous teeth will be collected from NCS children beginning at age five. Instructions on retrieval and shipment and to postage-paid shipping materials will be provided to participants.

Environmental Sample Collection:

Noise measurements will be taken at the homes of randomly-selected enrolled participants. With their consent, their homes will be equipped with a noise meter and measured for noise levels at various time intervals, and data collectors will ask questions about the source and frequency of noise they encounter at home.

Physical Measures:

BIA, or bioelectrical impedance analysis, is a non-invasive method for estimation of body composition including Body Mass Index. BIA will be measured on a small subsample of approximately 200 NCS children. For comparison, conventional skinfold measurements using previously approved and implemented protocols will be collected. Physical activity in children will be measured with accelerometers at three data collection points with a subsample of approximately 600 NCS enrolled children. Participants will be asked to wear the Actigraph GT3X-plus physical activity monitor on their wrist for a 7-day period. Pulmonary function will be measured at age five through spirometry, a simple, non-invasive method.

NIH Toolbox Measures:

The NIH Toolbox (

www.nihtoolbox.org

) is a series of short assessments designed to measure emotional, cognitive, sensory, and motor function in children as young as age three.

Assessing Participant Experience:

NCS participants will be asked to complete self-administered questionnaires designed to assess feelings towards the NCS and motivation to be engaged in research. Through the use of these instruments, the NCS aims to maintain positive relationships with participants and allow them to provide useful feedback about the Study, its procedures and perceived value to them, their families, and communities.

Retrospective Pregnancy Questionnaire:

Women who joined the NCS after the birth of the enrolled child will be asked to complete a Retrospective Pregnancy Questionnaire designed to collect prenatal medical information.

OMB approval is requested for 3 years. The additional annualized cost to respondents over the 3 year data collection period is estimated at an annualized cost of $633,541 (based on $10 per hour). The total estimated annualized burden hours are 63,354 hours (see Table 1).

Table 1—Estimated Annualized Burden Hours for Vanguard (Pilot) Study Respondents, Study Visits Through 60 Months of Age of the Child

Data collection activity

Type of respondent

Estimated number of

respondents

Estimated number of

responses per respondent

Average

burden per

response

(in hrs)

Estimated total annual burden hours

Pregnancy Screening Activities:

Pregnancy Screener Sibling Birth Cohort SAQ

(9M to 60M)

Biological Mother

1,122

10

3/60

561

Retrospective Pregnancy Interview

(Birth, 3M, 6M)

Biological Mother

422

1

47/60

331

Continuous Activities:

Participant Verification & Tracing (PVT) Interview

(PV1 to 60M)

Pregnant Woman, Father/Father Figure, Biological Mother, Primary Caregiver, Secondary Residence Caregiver

877

15

7/60

1,535

Validation Interview

(Pre-Pregnancy to 60M)

Pregnant Woman, Father/Father Figure, Biological Mother, Primary Caregiver, Secondary Residence Caregiver

850

1

2/60

28

Participant Information Update—Incentive Substudy

(24M to 60M)

Primary Caregiver

1,364

1

5/60

114

Event Driven Activities:

Pregnancy Loss, Stillbirth, & Neonatal Death Interview

(PV1, PV2, Birth)

Pregnant Woman, Biological Mother

13

1

17/60

4

Parent-Caregiver Death Interview

(3M to 60M)

Proxy

3

1

3/60

0.17

Child Death Interview

(3M to 60M)

Primary Caregiver

4

1

3/60

0.22

Non-Interview Respondent Interview

(Pre-Pregnancy to 60M)

Pre-Pregnant Woman, Pregnant Woman, Father/Father Figure, Biological Mother, Primary Caregiver

603

1

5/60

50

Secondary Residence Interview

(36M, 48M, 60M)

Secondary Residence Caregiver

221

1

13/60

48

Preconception Activities:

Pre-Pregnancy Interview

Pre-Pregnant Woman

445

1

21/60

156

Adult-Focused Biospecimen Collection—Blood & Urine

Pre-Pregnant Woman

356

1

26/60

154

Pregnancy Probability Group Follow-up

Pre-Pregnant Woman

445

1

15/60

111

Pre-Natal Activities:

Pregnancy Visit 1 Interview

Pregnant Woman

333

1

50/60

278

Pregnancy Visit 2 Interview

Pregnant Woman

333

1

18/60

100

Adult-Focused Biospecimen Collection—Blood & Urine

(PV1, PV2)

Pregnant Woman

267

2

26/60

231

Environmental Sample Collection—Vacuum Bag Dust

(PV1)

Primary Caregiver

283

1

3/60

14

Father Pre-Natal Interview

(PV1 or PV2)

Father/Father Figure

317

1

32/60

169

Pregnancy Health Care Log

(PV1 or PV2)

Biological Mother

333

1

5/60

28

Birth Activities:

Birth Interview

Biological Mother

317

1

15/60

79

Adult-Focused Biospecimen Collection—Blood, Urine, Cord Blood, Breast Milk, Placenta, & Microbiome Swab

Biological Mother

253

1

85/60

358

Child-Focused Biospecimen Collection—Infant Blood Spot

Child

253

1

3/60

13

Post-Natal Activities:

Infant & Child Health Care Log

(Birth to 60M)

Primary Caregiver

2,067

1

5/60

172

3-Month Interview

Primary Caregiver

475

1

37/60

293

Biological Mother

475

1

2/60

16

Adult-Focused Biospecimen Collection—Breast Milk, Blood, Urine, Saliva, & Microbiome Swab

(3M, 6M, 12M, 24M, 36M, 48M, 60M)

Primary Caregiver

832

14

40/60

7,811

6-Month Interview

Primary Caregiver

475

1

32/60

253

Core Questionnaire—Child, Adult, & Household

(6M to 60M, except 9M)

Primary Caregiver

1,107

9

34/60

5,646

Child-Focused Biospecimen Collection—Urine, Blood, Saliva, Microbiome Swab, & Teeth

(6M, 12M, 24M, 36M, 48M, 60M)

Primary Caregiver

886

14

44/60

9,027

9-Month Interview

Primary Caregiver

554

1

3/60

28

Father Post-Natal Interview

(9M or 18M)

Father/Father Figure

558

1

14/60

130

12-Month Interview

Primary Caregiver

554

1

34/60

314

Child-Focused Physical Measures—Anthropometry, Blood Pressure, Vision Screening, Lung Function, & Motor Skills

(6M, 12M, 24M, 36M, 48M, 60M)

Child

1,217

2

9/60

365

Primary Caregiver

935

13

41/60

8,375

Environmental Sample Collection—Vacuum Bag Dust, Indoor and Outdoor Visual Observations, & Dust Wipes

(12M, 36M, 48M, 60M)

Primary Caregiver

1,085

13

8/60

1,775

18-Month Interview

Primary Caregiver

562

1

40/60

375

24-Month Interview

Primary Caregiver

1,046

1

26/60

453

30-Month Interview

Primary Caregiver

1,286

1

50/60

1,072

36-Month Interview

Primary Caregiver

1,711

1

61/60

1,740

Child

1,711

1

22/60

627

42-Month Interview

Primary Caregiver

1,364

1

32/60

728

Biological Mother, Biological Father

1,364

1

15/60

341

48-Month Interview

Primary Caregiver

1,380

1

89/60

2,047\

54-Month Interview

Primary Caregiver

1,431

1

23/60

549

60-Month Interview

Primary Caregiver

1,332

1

46/60

1,021

Child

1,332

1

22/60

488

Subsample Studies:

Noise

(36M, 60M)

Primary Caregiver

200

2

17/60

113

Bioelectrical Impedance Analysis (BIA)

(48M, 60M)

Primary Caregiver

67

2

7/60

16

Physical Activity (Accelerometer)

(36M, 48M, 60M)

Primary Caregiver

200

3

43/60

430

Total Vanguard (Pilot) Study

48,567

Total Formative Research

2,835

Dated: December 6, 2013.

Sarah L. Glavin,

Deputy Director, Office of Science Policy, Analysis, and Communications, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health.

[FR Doc. 2013-30091 Filed 12-17-13; 8:45 am]

BILLING CODE 4140-01-P