The National Children's Study, Vanguard (Pilot) Study; Submission for OMB Review; 30-Day Comment Request, 76629-76632 [2013-30091]

Download as PDF Federal Register / Vol. 78, No. 243 / Wednesday, December 18, 2013 / Notices The Agencies have decided to continue the program as currently designed for an additional period of 2 years from the date of publication of this notice. DATES: This notice is effective December 18, 2013. FOR FURTHER INFORMATION CONTACT: John Burke, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5460, Silver Spring, MD 20993–0002, 301–796–5738, John.Burke@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In the Federal Register of October 11, 2011 (76 FR 62808), the Agencies announced the procedures and guiding principles for the Parallel Review Pilot Program and solicited nominations for the pilot. To date, there has been significant interest in the pilot and the Agencies are currently working through the parallel review process with the approved pilot program participants. We believe that interest in the pilot has also facilitated mutually informative discussions between additional sponsors and the Agencies. In the October 11, 2011 (76 FR 62808), Parallel Review Pilot Program notice, the Agencies stated their intent to accept requests for a 2-year period, followed by an announcement in the Federal Register as to the future of the pilot. The Agencies have decided to continue the program as currently designed for an additional 2 years from the date of publication of this notice. Once a representative group of participants have completed the pilot process the Agencies will formally evaluate the program for best practices and will announce any future revisions and/or enhancements in a future Federal Register notice. Dated: December 5, 2013. Marilyn Tavenner, Administrator, Centers for Medicare & Medicaid Services. Dated: December 6, 2013. Margaret A. Hamburg, Commissioner of Food and Drugs. [FR Doc. 2013–29822 Filed 12–17–13; 8:45 am] BILLING CODE 4120–01–M; 4160–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES ehiers on DSK2VPTVN1PROD with NOTICES National Institutes of Health The National Children’s Study, Vanguard (Pilot) Study; Submission for OMB Review; 30-Day Comment Request In compliance with the requirement of Section 3506(c)(2)(A) of SUMMARY: VerDate Mar<15>2010 15:27 Dec 17, 2013 Jkt 232001 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. 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 FOR FURTHER INFORMATION CONTACT: PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 76629 (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 E:\FR\FM\18DEN1.SGM 18DEN1 76630 Federal Register / Vol. 78, No. 243 / Wednesday, December 18, 2013 / Notices 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 7day 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 ehiers on DSK2VPTVN1PROD with NOTICES Data collection activity Estimated number of respondents Type of respondent Pregnancy Screening Activities: Pregnancy Screener Sibling Biological Mother ............................. Birth Cohort SAQ (9M to 60M). Retrospective Pregnancy Inter- Biological Mother ............................. view (Birth, 3M, 6M). Continuous Activities: Participant Verification & Tracing Pregnant Woman, Father/Father (PVT) Interview (PV1 to 60M). Figure, Biological Mother, Primary Caregiver, Secondary Residence Caregiver. Validation Interview (Pre-Preg- Pregnant Woman, Father/Father nancy to 60M). Figure, Biological Mother, Primary Caregiver, Secondary Residence Caregiver. VerDate Mar<15>2010 15:27 Dec 17, 2013 Jkt 232001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 Estimated number of responses per respondent Average burden per response (in hrs) Estimated total annual burden hours 1,122 10 3/60 561 422 1 47/60 331 877 15 7/60 1,535 850 1 2/60 28 E:\FR\FM\18DEN1.SGM 18DEN1 76631 Federal Register / Vol. 78, No. 243 / Wednesday, December 18, 2013 / Notices TABLE 1—ESTIMATED ANNUALIZED BURDEN HOURS FOR VANGUARD (PILOT) STUDY RESPONDENTS, STUDY VISITS THROUGH 60 MONTHS OF AGE OF THE CHILD—Continued Estimated number of responses per respondent Estimated number of respondents Average burden per response (in hrs) Estimated total annual burden hours Data collection activity Type of respondent Participant Information Update— Incentive Substudy (24M to 60M). Event Driven Activities: Pregnancy Loss, Stillbirth, & Neonatal Death Interview (PV1, PV2, Birth). Parent-Caregiver Death Interview (3M to 60M). Child Death Interview (3M to 60M). Non-Interview Respondent Interview (Pre-Pregnancy to 60M). Primary Caregiver ............................ 1,364 1 5/60 114 Pregnant Woman, Biological Mother 13 1 17/60 4 Proxy ................................................ 3 1 3/60 0.17 Primary Caregiver ............................ 4 1 3/60 0.22 Pre-Pregnant Woman, Pregnant Woman, Father/Father Figure, Biological Mother, Primary Caregiver. Secondary Residence Caregiver ..... 603 1 5/60 50 221 1 13/60 48 Pre-Pregnant Woman ...................... Pre-Pregnant Woman ...................... 445 356 1 1 21/60 26/60 156 154 Pre-Pregnant Woman ...................... 445 1 15/60 111 Pregnant Woman ............................. Pregnant Woman ............................. Pregnant Woman ............................. 333 333 267 1 1 2 50/60 18/60 26/60 278 100 231 Primary Caregiver ............................ 283 1 3/60 14 Father/Father Figure ........................ 317 1 32/60 169 Biological Mother ............................. 333 1 5/60 28 Biological Mother ............................. Biological Mother ............................. 317 253 1 1 15/60 85/60 79 358 Child ................................................. 253 1 3/60 13 Primary Caregiver ............................ 2,067 1 5/60 172 Primary Caregiver ............................ Biological Mother ............................. Primary Caregiver ............................ 475 475 832 1 1 14 37/60 2/60 40/60 293 16 7,811 Primary Caregiver ............................ Primary Caregiver ............................ 475 1,107 1 9 32/60 34/60 253 5,646 Primary Caregiver ............................ 886 14 44/60 9,027 Primary Caregiver ............................ Father/Father Figure ........................ 554 558 1 1 3/60 14/60 28 130 Primary Caregiver ............................ 554 1 34/60 314 ehiers on DSK2VPTVN1PROD with NOTICES Secondary Residence Interview (36M, 48M, 60M). Preconception Activities: Pre-Pregnancy Interview ............ Adult-Focused Biospecimen Collection—Blood & Urine. Pregnancy Probability Group Follow-up. Pre-Natal Activities: Pregnancy Visit 1 Interview ....... Pregnancy Visit 2 Interview ....... Adult-Focused Biospecimen Collection—Blood & Urine (PV1, PV2). Environmental Sample Collection—Vacuum Bag Dust (PV1). Father Pre-Natal Interview (PV1 or PV2). Pregnancy Health Care Log (PV1 or PV2). Birth Activities: Birth Interview ............................ Adult-Focused Biospecimen Collection—Blood, Urine, Cord Blood, Breast Milk, Placenta, & Microbiome Swab. Child-Focused Biospecimen Collection—Infant Blood Spot. Post-Natal Activities: Infant & Child Health Care Log (Birth to 60M). 3-Month Interview ...................... Adult-Focused Biospecimen Collection—Breast Milk, Blood, Urine, Saliva, & Microbiome Swab (3M, 6M, 12M, 24M, 36M, 48M, 60M). 6-Month Interview ...................... Core Questionnaire—Child, Adult, & Household (6M to 60M, except 9M). Child-Focused Biospecimen Collection—Urine, Blood, Saliva, Microbiome Swab, & Teeth (6M, 12M, 24M, 36M, 48M, 60M). 9-Month Interview ...................... Father Post-Natal Interview (9M or 18M). 12-Month Interview .................... VerDate Mar<15>2010 15:27 Dec 17, 2013 Jkt 232001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\18DEN1.SGM 18DEN1 76632 Federal Register / Vol. 78, No. 243 / Wednesday, December 18, 2013 / Notices TABLE 1—ESTIMATED ANNUALIZED BURDEN HOURS FOR VANGUARD (PILOT) STUDY RESPONDENTS, STUDY VISITS THROUGH 60 MONTHS OF AGE OF THE CHILD—Continued Data collection activity Estimated number of respondents Type of respondent Child-Focused Physical Measures—Anthropometry, Blood Pressure, Vision Screening, Lung Function, & Motor Skills (6M, 12M, 24M, 36M, 48M, 60M). Estimated number of responses per respondent Average burden per response (in hrs) Estimated total annual burden hours Child ................................................. 1,217 2 9/60 365 Primary Caregiver ............................ Primary Caregiver ............................ 935 1,085 13 13 41/60 8/60 8,375 1,775 Primary Caregiver ............................ Primary Caregiver ............................ Primary Caregiver ............................ Primary Caregiver ............................ Child ................................................. Primary Caregiver ............................ Biological Mother, Biological Father Primary Caregiver ............................ Primary Caregiver ............................ Primary Caregiver ............................ Child ................................................. 562 1,046 1,286 1,711 1,711 1,364 1,364 1,380 1,431 1,332 1,332 1 1 1 1 1 1 1 1 1 1 1 40/60 26/60 50/60 61/60 22/60 32/60 15/60 89/60 23/60 46/60 22/60 375 453 1,072 1,740 627 728 341 2,047\ 549 1,021 488 Primary Caregiver ............................ Primary Caregiver ............................ 200 67 2 2 17/60 7/60 113 16 Primary Caregiver ............................ 200 3 43/60 430 Total Vanguard (Pilot) Study .......................................................... ........................ ........................ ........................ 48,567 Total Formative Research .. .......................................................... ........................ ........................ ........................ 2,835 Environmental Sample Collection—Vacuum Bag Dust, Indoor and Outdoor Visual Observations, & Dust Wipes (12M, 36M, 48M, 60M). 18-Month Interview .................... 24-Month Interview .................... 30-Month Interview .................... 36-Month Interview .................... 42-Month Interview .................... 48-Month Interview .................... 54-Month Interview .................... 60-Month Interview .................... Subsample Studies: Noise (36M, 60M) ...................... Bioelectrical Impedance Analysis (BIA) (48M, 60M). Physical Activity (Accelerometer) (36M, 48M, 60M). 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health ehiers on DSK2VPTVN1PROD with NOTICES National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose VerDate Mar<15>2010 15:27 Dec 17, 2013 Jkt 232001 confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Biomedical Imaging and Bioengineering Special Emphasis Panel; Low-Dose CT Imaging (UO1). Date: February 26, 2014. Time: 9:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, DEM II, Suite 951, 6707 Democracy Boulevard, Bethesda, MD 20892, (Virtual Meeting). Contact Person: John K. Hayes, Ph.D., Scientific Review Officer, National Institute of Biomedical Imaging and Bioengineering, 6707 Democracy Boulevard, Suite 959, Bethesda, MD 20892, 301–451–3398, hayesj@ mail.nih.gov. Dated: December 12, 2013. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2013–30012 Filed 12–17–13; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of meetings of the National Diabetes and Digestive and Kidney Diseases Advisory Council. The meetings will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose E:\FR\FM\18DEN1.SGM 18DEN1

Agencies

[Federal Register Volume 78, Number 243 (Wednesday, December 18, 2013)]
[Notices]
[Pages 76629-76632]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-30091]


-----------------------------------------------------------------------

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

[[Page 76630]]

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
----------------------------------------------------------------------------------------------------------------
                                                                     Estimated        Average
                                     Type of         Estimated       number of      burden per       Estimated
   Data collection activity        respondent        number of     responses per   response  (in   total annual
                                                    respondents     respondent         hrs)        burden hours
----------------------------------------------------------------------------------------------------------------
Pregnancy Screening
 Activities:
    Pregnancy Screener Sibling  Biological                 1,122              10            3/60             561
     Birth Cohort SAQ (9M to     Mother.
     60M).
    Retrospective Pregnancy     Biological                   422               1           47/60             331
     Interview (Birth, 3M, 6M).  Mother.
Continuous Activities:
    Participant Verification &  Pregnant Woman,              877              15            7/60           1,535
     Tracing (PVT) Interview     Father/Father
     (PV1 to 60M).               Figure,
                                 Biological
                                 Mother, Primary
                                 Caregiver,
                                 Secondary
                                 Residence
                                 Caregiver.
    Validation Interview (Pre-  Pregnant Woman,              850               1            2/60              28
     Pregnancy to 60M).          Father/Father
                                 Figure,
                                 Biological
                                 Mother, Primary
                                 Caregiver,
                                 Secondary
                                 Residence
                                 Caregiver.

[[Page 76631]]

 
    Participant Information     Primary                    1,364               1            5/60             114
     Update--Incentive           Caregiver.
     Substudy (24M to 60M).
Event Driven Activities:
    Pregnancy Loss,             Pregnant Woman,               13               1           17/60               4
     Stillbirth, & Neonatal      Biological
     Death Interview (PV1,       Mother.
     PV2, Birth).
    Parent-Caregiver Death      Proxy...........               3               1            3/60            0.17
     Interview (3M to 60M).
    Child Death Interview (3M   Primary                        4               1            3/60            0.22
     to 60M).                    Caregiver.
    Non-Interview Respondent    Pre-Pregnant                 603               1            5/60              50
     Interview (Pre-Pregnancy    Woman, Pregnant
     to 60M).                    Woman, Father/
                                 Father Figure,
                                 Biological
                                 Mother, Primary
                                 Caregiver.
    Secondary Residence         Secondary                    221               1           13/60              48
     Interview (36M, 48M, 60M).  Residence
                                 Caregiver.
Preconception Activities:
    Pre-Pregnancy Interview...  Pre-Pregnant                 445               1           21/60             156
                                 Woman.
    Adult-Focused Biospecimen   Pre-Pregnant                 356               1           26/60             154
     Collection--Blood & Urine.  Woman.
    Pregnancy Probability       Pre-Pregnant                 445               1           15/60             111
     Group Follow-up.            Woman.
Pre-Natal Activities:
    Pregnancy Visit 1           Pregnant Woman..             333               1           50/60             278
     Interview.
    Pregnancy Visit 2           Pregnant Woman..             333               1           18/60             100
     Interview.
    Adult-Focused Biospecimen   Pregnant Woman..             267               2           26/60             231
     Collection--Blood & Urine
     (PV1, PV2).
    Environmental Sample        Primary                      283               1            3/60              14
     Collection--Vacuum Bag      Caregiver.
     Dust (PV1).
    Father Pre-Natal Interview  Father/Father                317               1           32/60             169
     (PV1 or PV2).               Figure.
    Pregnancy Health Care Log   Biological                   333               1            5/60              28
     (PV1 or PV2).               Mother.
Birth Activities:
    Birth Interview...........  Biological                   317               1           15/60              79
                                 Mother.
    Adult-Focused Biospecimen   Biological                   253               1           85/60             358
     Collection--Blood, Urine,   Mother.
     Cord Blood, Breast Milk,
     Placenta, & Microbiome
     Swab.
    Child-Focused Biospecimen   Child...........             253               1            3/60              13
     Collection--Infant Blood
     Spot.
Post-Natal Activities:
    Infant & Child Health Care  Primary                    2,067               1            5/60             172
     Log (Birth to 60M).         Caregiver.
    3-Month Interview.........  Primary                      475               1           37/60             293
                                 Caregiver.
                                Biological                   475               1            2/60              16
                                 Mother.
    Adult-Focused Biospecimen   Primary                      832              14           40/60           7,811
     Collection--Breast Milk,    Caregiver.
     Blood, Urine, Saliva, &
     Microbiome Swab (3M, 6M,
     12M, 24M, 36M, 48M, 60M).
    6-Month Interview.........  Primary                      475               1           32/60             253
                                 Caregiver.
    Core Questionnaire--Child,  Primary                    1,107               9           34/60           5,646
     Adult, & Household (6M to   Caregiver.
     60M, except 9M).
    Child-Focused Biospecimen   Primary                      886              14           44/60           9,027
     Collection--Urine, Blood,   Caregiver.
     Saliva, Microbiome Swab,
     & Teeth (6M, 12M, 24M,
     36M, 48M, 60M).
    9-Month Interview.........  Primary                      554               1            3/60              28
                                 Caregiver.
    Father Post-Natal           Father/Father                558               1           14/60             130
     Interview (9M or 18M).      Figure.
    12-Month Interview........  Primary                      554               1           34/60             314
                                 Caregiver.

[[Page 76632]]

 
    Child-Focused Physical      Child...........           1,217               2            9/60             365
     Measures--Anthropometry,
     Blood Pressure, Vision
     Screening, Lung Function,
     & Motor Skills (6M, 12M,
     24M, 36M, 48M, 60M).
                                Primary                      935              13           41/60           8,375
                                 Caregiver.
    Environmental Sample        Primary                    1,085              13            8/60           1,775
     Collection--Vacuum Bag      Caregiver.
     Dust, Indoor and Outdoor
     Visual Observations, &
     Dust Wipes (12M, 36M,
     48M, 60M).
    18-Month Interview........  Primary                      562               1           40/60             375
                                 Caregiver.
    24-Month Interview........  Primary                    1,046               1           26/60             453
                                 Caregiver.
    30-Month Interview........  Primary                    1,286               1           50/60           1,072
                                 Caregiver.
    36-Month Interview........  Primary                    1,711               1           61/60           1,740
                                 Caregiver.
                                Child...........           1,711               1           22/60             627
    42-Month Interview........  Primary                    1,364               1           32/60             728
                                 Caregiver.
                                Biological                 1,364               1           15/60             341
                                 Mother,
                                 Biological
                                 Father.
    48-Month Interview........  Primary                    1,380               1           89/60          2,047\
                                 Caregiver.
    54-Month Interview........  Primary                    1,431               1           23/60             549
                                 Caregiver.
    60-Month Interview........  Primary                    1,332               1           46/60           1,021
                                 Caregiver.
                                Child...........           1,332               1           22/60             488
Subsample Studies:
    Noise (36M, 60M)..........  Primary                      200               2           17/60             113
                                 Caregiver.
    Bioelectrical Impedance     Primary                       67               2            7/60              16
     Analysis (BIA) (48M, 60M).  Caregiver.
    Physical Activity           Primary                      200               3           43/60             430
     (Accelerometer) (36M,       Caregiver.
     48M, 60M).
                                                 ---------------------------------------------------------------
        Total Vanguard (Pilot)  ................  ..............  ..............  ..............          48,567
         Study.
                                                 ---------------------------------------------------------------
        Total Formative         ................  ..............  ..............  ..............           2,835
         Research.
----------------------------------------------------------------------------------------------------------------


    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