Continuation of National Children's Study Vanguard (Pilot) Study Data Collection: Study Visits through 60-Months and Sibling Birth Enrollment

Forms and Documents

Document Name	Status
Form 45.1 Father Post-Natal Interview Form and Instruction	New
Form 45.1 Retrospective Pregnancy Interview Form and Instruction	New
Form 43.1 Environmental Sample Collection (Prenatal) Form and Instruction	New
Form 42.1 Physical Activity Subsample Study Form and Instruction	New
Form 41.1 Bioelectrical Impedance Analysis Subsample Study Form and Instruction	New
Form 40.1 Noise Subsample Study Form and Instruction	New
Form 39.1 Participant Information Update - Incentive Substudy Form and Instruction	New
Form 38.2 36-Month Interview Form and Instruction	New
Form 37.1 60-Month Interview Form and Instruction	New
Form 36.1 54-Month Interview Form and Instruction	New
Form 35.2 48-Month Interview Form and Instruction	New
Form 34.1 42-Month Interview Form and Instruction	New
Form 33.1 Child-Focused Biospecimen Collection (Birth) Form and Instruction	New
Form 32.2 Adult-Focused Biospecimen Collection (Birth) Form and Instruction	New
Form 31.1 Pregnancy Probability Group Follow-up Interview Form and Instruction	New
Form 30.2 Adult-Focused Biospecimen Collection (Preconception) Form and Instruction	New
Form 29.1 Secondary Residence Interview Form and Instruction	New
Form 28.1 Revised Parent-Caregiver & Child Death Interview Form and Instruction	New
Form 27.1 30-Month Interview Form and Instruction	Modified
Form 26.3 Core Questionnaire - Child, Adult, & Household Form and Instruction	Modified
Form 25.1 Adult-Focused Biospecimen Collection (Postnatal) Form and Instruction	Modified
Form 24.1 Child-Focused Physical Measures (Postnatal) Form and Instruction	Modified
Form 23.1 Child-Focused Biospecimen Collection (Postnatal) Form and Instruction	Modified
Form 22.1 Environmental Sample Collection (Postnatal) Form and Instruction	Modified
Form 21.1 Participant Verification & Tracing Interview Form and Instruction	Modified
Form 20.1 Non-Interview Respondent Interview Form and Instruction	Modified
Form 19.1 Pregnancy Loss, Stillbirth, & Neonatal Death Interview Form and Instruction	Modified
Form 18.1 Pregnancy Screener Form and Instruction	Modified
Form 17.1 Formative Research Form and Instruction	Modified
Form 16.1 24-Month Interview Form and Instruction	Modified
Form 15.6 18-Month Interview Form and Instruction	Modified
Form 14.1 12-Month Interview Form and Instruction	Modified
Form 13.1 9-Month Interview Form and Instruction	Modified
Form 12.1 6-Month Interview Form and Instruction	Modified
Form 11.1 3-Month Interview Form and Instruction	Modified
Form 10.1 Infant & Child Health Care Log Form and Instruction	Modified
Form 14.1 Low-Intensity Questionnaire (Birth focus) (TT-LI) Form and Instruction	Removed
Form 8.1 Birth Interview Form and Instruction	Modified
Form 7.1 Father Pre-Natal Interview Form and Instruction	Modified
Form 6.1 Pregnancy Health Care Log Form and Instruction	Modified
Form 5.1 Pregnancy Visit 2 Interview Form and Instruction	Modified
Form 4.1 Pregnancy Visit 1 Interview Form and Instruction	Modified
Form 3.1 Validation Interview Form and Instruction	Modified
Form 2.1 Pre-Pregnancy Interview Form and Instruction	Modified
Form 1.1 Adult-Focused Biospecimen Collection (Prenatal) Form and Instruction	Modified
NCS Vanguard Study Request for Revision SSB_REVISED.docx Supporting Statement B	2014-05-19
Attach. 1 NCS Vanguard Study Informed Consent 12092013.pdf Supplementary Document	2013-12-09
Attach. 5 Instruments by Data Collection Activity As of May152014.docx Supplementary Document	2014-05-19
Attach. 2 Instruments by Event and Stage of OMB Review As of May152014.docx Supplementary Document	2014-05-19
Interviewer Observation (Data Collector Completed).pdf Supplementary Document	2013-12-09
Note to File - Informed Consents.docx Supplementary Document	2013-11-13
Attach. 4 Description of NCS Vanguard Study Visits.docx Supplementary Document	2013-11-08
Attach. 3 NCS Certificate of Confidentiality.pdf Supplementary Document	2013-11-08
PhysicalActivityMonitorGPSInstructions.docx Supplementary Document	2013-11-07
36M_HomeSocialDirectObservationInstrument.docx Supplementary Document	2013-11-08
MajorLifeEventsInstructions.docx Supplementary Document	2013-11-07
SWANBehaviorRatingScalesInstructions.docx Supplementary Document	2013-11-07
ASQ3InPersonMailInstructions.docx Supplementary Document	2013-11-07
MajorLifeEventsInstructions.docx Supplementary Document	2013-11-07
SWANBehaviorRatingScalesInstructions.docx Supplementary Document	2013-11-07
ASQ3InPersonMailInstructions.docx Supplementary Document	2013-11-07
ASQ3InPersonMailInstructions.docx Supplementary Document	2013-11-07
Birth_ChildBiospecimenPickUpInstrument.docx Supplementary Document	2013-11-08
AdultMicrobiomeRectalSwabInstructions.docx Supplementary Document	2013-11-07
BreastMilkInstructions.docx Supplementary Document	2013-11-07
AdultUrineInstructions.doc Supplementary Document	2013-11-07
BreastMilkKitLetter.docx Supplementary Document	2013-11-06
AdultUrineInstructions.doc Supplementary Document	2013-11-07
30M_InfantToddlerSensoryProfilePhoneInstructions.docx Supplementary Document	2013-11-07
30M_InfantToddlerSensoryProfileMailInstructions.docx Supplementary Document	2013-11-07
30M_BSIMailInstructions.docx Supplementary Document	2013-11-07
BITSEAPhoneInstructions.docx Supplementary Document	2013-11-07
BITSEAInPersonMailInstructions.docx Supplementary Document	2013-11-07
VaccinationGridCoreModule.docx Supplementary Document	2013-11-08
AdultMicrobiomeRectalSwabInstructions.docx Supplementary Document	2013-11-07
BreastMilkInstructions.docx Supplementary Document	2013-11-07
AdultUrineInstructions.doc Supplementary Document	2013-11-07
BreastMilkKitLetter.docx Supplementary Document	2013-11-06
24M_ChildMicrobiomeStoolInstructions.docx Supplementary Document	2013-11-07
ChildUrineBagInstructions.docx Supplementary Document	2013-11-07
ChildUrineInstructions.docx Supplementary Document	2013-11-07
60M_ChildTeethInstructions.docx Supplementary Document	2013-11-07
OutdoorStructureObservationInstrument.docx Supplementary Document	2013-11-08
PVTKeyDataVerificationForm.docx Supplementary Document	2013-11-08
PVTContactVerificationForm.docx Supplementary Document	2013-11-08
PLSNDPhoneRemindCallScript.docx Supplementary Document	2013-11-08
PLSNDMailRemindCallScript.docx Supplementary Document	2013-11-08
PLSNDSAQReleaseLetter.docx Supplementary Document	2013-11-08
MCHATInPersonMailInstructions.docx Supplementary Document	2013-11-07
ASQ3InPersonMailInstructions.docx Supplementary Document	2013-11-07
PAIRSAQInstructions.docx Supplementary Document	2013-11-08
MCHATInPersonMailInstructions.docx Supplementary Document	2013-11-07
BITSEAPhoneInstructions.docx Supplementary Document	2013-11-07
BITSEAInPersonMailInstructions.docx Supplementary Document	2013-11-07
ASQ3InPersonMailInstructions.docx Supplementary Document	2013-11-07
ASQ3InPersonMailInstructions.docx Supplementary Document	2013-11-07
3M_InfantBehaviorRevised3SubscalesInstructions.docx Supplementary Document	2013-11-07
3M_EdinburghPostnatalDepressionScaleInstructions.docx Supplementary Document	2013-11-07
ASQ3PhoneInstructions.docx Supplementary Document	2013-11-07
MultiModeVisitInformationScript.docx Supplementary Document	2013-11-14
AdultUrineInstructions.doc Supplementary Document	2013-11-07
NCS Vanguard Study Request for Revision SSA_REVISED.docx Supporting Statement A	2014-05-19

IC Document Collections

IC ID	Document Title	Status
210037	Father Post-Natal Interview Form and Instruction	New
210036	Retrospective Pregnancy Interview Form and Instruction	New
210035	Environmental Sample Collection (Prenatal) Form and Instruction	New
210034	Physical Activity Subsample Study Form and Instruction	New
210033	Bioelectrical Impedance Analysis Subsample Study Form and Instruction	New
210032	Noise Subsample Study Form and Instruction	New
210031	Participant Information Update - Incentive Substudy Form and Instruction	New
210030	36-Month Interview Form and Instruction	New
210029	60-Month Interview Form and Instruction	New
210028	54-Month Interview Form and Instruction	New
210027	48-Month Interview Form and Instruction	New
210026	42-Month Interview Form and Instruction	New
210025	Child-Focused Biospecimen Collection (Birth) Form and Instruction	New
210024	Adult-Focused Biospecimen Collection (Birth) Form and Instruction	New
210023	Pregnancy Probability Group Follow-up Interview Form and Instruction	New
210022	Adult-Focused Biospecimen Collection (Preconception) Form and Instruction	New
210021	Secondary Residence Interview Form and Instruction	New
210020	Parent-Caregiver & Child Death Interview Form and Instruction	New
202215	30-Month Interview Form and Instruction	Modified
202214	Core Questionnaire - Child, Adult, & Household Form and Instruction	Modified
202213	Adult-Focused Biospecimen Collection (Postnatal) Form and Instruction	Modified
202212	Child-Focused Physical Measures (Postnatal) Form and Instruction	Modified
202211	Child-Focused Biospecimen Collection (Postnatal) Form and Instruction	Modified
202210	Environmental Sample Collection (Postnatal) Form and Instruction	Modified
202209	Participant Verification & Tracing Interview Form and Instruction	Modified
202208	Non-Interview Respondent Interview Form and Instruction	Modified
202207	Pregnancy Loss, Stillbirth, & Neonatal Death Interview Form and Instruction	Modified
202206	Pregnancy Screener Form and Instruction	Modified
193580	Formative Research Form and Instruction	Modified
193579	24-Month Interview Form and Instruction	Modified
193578	18-Month Interview Form and Instruction	Modified
193577	12-Month Interview Form and Instruction	Modified
193576	9-Month Interview Form and Instruction	Modified
193575	6-Month Interview Form and Instruction	Modified
193574	3-Month Interview Form and Instruction	Modified
193572	Infant & Child Health Care Log Form and Instruction	Modified
193571	Low-Intensity Questionnaire (Birth focus) (TT-LI) Form and Instruction	Removed
193570	Birth Interview Form and Instruction	Modified
193569	Father Pre-Natal Interview Form and Instruction	Modified
193567	Pregnancy Health Care Log Form and Instruction	Modified
193566	Pregnancy Visit 2 Interview Form and Instruction	Modified
193565	Pregnancy Visit 1 Interview Form and Instruction	Modified
193563	Validation Interview Form and Instruction	Modified
193562	Pre-Pregnancy Interview Form and Instruction	Modified
193560	Adult-Focused Biospecimen Collection (Prenatal) Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0593	ICR Reference No: 201401-0925-004
Status: Historical Active	Previous ICR Reference No: 201211-0925-001
Agency/Subagency: HHS/NIH	Agency Tracking No: 20831
Title: Continuation of National Children's Study Vanguard (Pilot) Study Data Collection: Study Visits through 60-Months and Sibling Birth Enrollment
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 06/03/2014
	Date Received in OIRA: 01/13/2014
Terms of Clearance: This package is being approved in stages due to breadth and complexity of the changes requested. The approval granted May 2014 ONLY covers the following elements: a) the continuation of already established data collection events (age-defined Study Visits or trigger-based collections) including all associated instruments protocols and consent documents, b) revision to the previously approved 30 month Study Visit, c) establishment of new Study Visits at 36 and 42 months. Although subsequent approval must be sought before implementing new Study Visits at ages 48, 54, and 60 months, adding biospecimen sampling to prior approved visits, conducting substudies and incentive tests, and initiating the sibling cohort, no additional public comment is required for the re-submission of the refined requests for these study components because public comment has already been sought and preliminary instruments were provided in the original submission. Additional discussion is also required to ensure that datasets are made available to non-NCS researchers in a manner consistent with the context in which they were approved.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2017	36 Months From Approved	08/31/2014
Responses	113,521	0	55,748
Time Burden (Hours)	55,122	0	22,791
Cost Burden (Dollars)	0	0	0

---

Abstract: The purpose of the Vanguard (Pilot) Study is to assess the feasibility, acceptability, and cost of the recruitment strategy, study logistics and operations, and study visit assessments that will be used in the NCS Main Study. This Information Collection Request (ICR) serves as a formal request for renewal of the Vanguard Study clearance. It also covers several other important requests, including initiating a new cohort to be enrolled, revisions to the NCS protocol with both new and revised Study visits, and the initiation of methodological substudies. 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. The NCS Main Study design is being informed by the experience obtained in the NCS Vanguard Study, substudies and methodological research projects.

---

Authorizing Statute(s): PL: Pub.L. 106 - 310 1004 Name of Law: Childrens Health Act of 2000
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 52548	08/23/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 76629	12/18/2013
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 44

IC Title	Form No.	Form Name
18-Month Interview	15.1, 15.2, 15.4, 15.5, 15.6	Survey ,   Survey ,   Survey ,   Survey ,   Survey
24-Month Interview	16.1, 16.2, 16.4, 16.5, 16.6, 16.7, 16.3	Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey
Formative Research	17.1	Survey
Pregnancy Screener	18.1	Survey
Pregnancy Loss, Stillbirth, & Neonatal Death Interview	19.1, 19.2	Survey ,   Survey
Non-Interview Respondent Interview	20.1	Survey
Pre-Pregnancy Interview	2.1, 2.2, 2.3	Survey ,   Survey ,   Survey
Validation Interview	3.1	Survey
Pregnancy Visit 1 Interview	4.1, 4.2, 4.4, 4.3	Survey ,   Survey ,   Survey ,   Survey
Pregnancy Visit 2 Interview	5.1, 5.2, 5.3	Survey ,   Survey ,   Survey
Pregnancy Health Care Log	6.1	Survey
Father Pre-Natal Interview	7.2, 7.1	Survey ,   Survey
Birth Interview	8.1, 8.2, 8.3	Survey ,   Survey ,   Survey
Infant & Child Health Care Log	10.1	Survey
3-Month Interview	11.1, 11.2, 11.3, 11.4, 11.5, 11.6, 11.7, 11.8	Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey
6-Month Interview	12.1, 12.2, 12.3, 12.4, 12.5, 12.6, 12.7	Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey
9-Month Interview	13.1	Survey
12-Month Interview	14.1, 14.2, 14.3, 14.4, 14.5, 14.6, 14.7, 14.8, 14.9	Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey
Core Questionnaire - Child, Adult, & Household	26.1 Revised, 26.2, 26.3	Survey ,   Survey ,   Survey
30-Month Interview	27.1, 27.2, 27.3, 27.4, 27.5	Survey ,   Survey ,   Survey ,   Survey ,   Survey
Parent-Caregiver & Child Death Interview	28.1 Revised , 28.2 Revised	Survey ,   Survey
Secondary Residence Interview	29.1	Survey
Adult-Focused Biospecimen Collection (Preconception)	30.2, 30.1, 30.3	Survey ,   Survey ,   Survey
Pregnancy Probability Group Follow-up Interview	31.1	Survey
Adult-Focused Biospecimen Collection (Birth)	32.2, 32.3, 32.5, 32.7, 32.8, 32.4, 32.6, 32.9, 32.10, 32.1	Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey
Child-Focused Biospecimen Collection (Birth)	33.1	Survey
42-Month Interview	34.1, 34.3, 34.5, 34.6, 34.7, 34.4	Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey
48-Month Interview	35.2, 35.3, 35.4, 35.5, 35.6, 35.7, 35.8, 35.9, 35.1	Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey
54-Month Interview	36.1, 36.2, 36.3	Survey ,   Survey ,   Survey
60-Month Interview	37.1, 37.2, 37.3, 37.4, 37.5, 37.6, 37.7, 37.8	Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey
36-Month Interview	38.12 Revised, 38.2, 38.3, 38.4, 38.5, 38.6, 38.7, 38.9, 38.10, 38.11, 38.1	Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey
Participant Information Update - Incentive Substudy	39.1, 39.2, 39.3, 39.4	Survey ,   Survey ,   Survey ,   Survey
Noise Subsample Study	40.3, 40.1, 40.2	Survey ,   Survey ,   Survey
Bioelectrical Impedance Analysis Subsample Study	41.1	Survey
Physical Activity Subsample Study	42.1, 42.2, 42.3, 42.4	Survey ,   Survey ,   Survey ,   Survey
Environmental Sample Collection (Prenatal)	43.1	Survey
Retrospective Pregnancy Interview	45.1, 45.3, 45.2	Survey ,   Survey ,   Survey
Father Post-Natal Interview	45.1, 45.2, 45.3	Survey ,   Survey ,   Survey
Low-Intensity Questionnaire (Birth focus) (TT-LI)	14.1	Survey
Adult-Focused Biospecimen Collection (Prenatal)	1.1, 1.2, 1.4	Survey ,   Survey ,   Survey
Participant Verification & Tracing Interview	21.1	Survey
Environmental Sample Collection (Postnatal)	22.1, 22.2, 22.3, 22.5	Survey ,   Survey ,   Survey ,   Survey
Child-Focused Biospecimen Collection (Postnatal)	23.1, 23.2, 23.3, 23.4, 23.5, 23.6, 23.7, 23.8	Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey
Child-Focused Physical Measures (Postnatal)	24.1, 24.2, 24.3, 24.4, 24.5	Survey ,   Survey ,   Survey ,   Survey ,   Survey
Adult-Focused Biospecimen Collection (Postnatal)	25.1, 25.2, 25.3, 25.4, 25.5, 25.6, 25.7, 25.8	Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey

---

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	113,521	55,748	0	57,773	0	0
Annual Time Burden (Hours)	55,122	22,791	0	32,331	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: As noted in A.2, program changes/adjustments that affect burden include the initiation of a new enrollment cohort, the establishment of new Study visits, and revisions to already-established Study visits. The two proposed methodological substudies are designed to understand the impact of variable incentives on participation in existing and proposed study visits. On their own, these substudies do not impose additional participant burden. Currently, the NCS is approved for 22,911 annualized burden hours. With this ICR, the total annualized hour burden for the NCS Vanguard Study is approximately 51,402 hours, which is an increase in burden.

---

Annual Cost to Federal Government: $20,479,000

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

---

Common Form ICR:  No

---

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 01/10/2014

---