Biospecimen and Physical Measurements Formative Research Methodology Studies for the National Children?s Study (NICHD)

Forms and Documents

Document Name	Status
Form 2.3 LOI2-BIO-19 - Integration of salivary analytes into the NCS: Evaluation of Feasibility, Efficiency, and Benefits Form and Instruction	New
2011 Biospecimens Generic Clearance Request Part B 20111227 FINAL.docx Supporting Statement B	2012-01-05
Exemplar Consent Form LOI2-BIO-18.pdf Supplementary Document	2011-08-22
Exemplar Birth Visit Information Sheet 20110615.docx Supplementary Document	2011-08-22
Example Project Biospecimens Generic Clearance 20110622.docx Supplementary Document	2011-08-22
2011 Biospecimens Generic Clearance Request Part A 20111227 FINAL.docx Supporting Statement A	2012-01-05

IC Document Collections

IC ID	Document Title	Status
204811	LOI3-RT-01-N GC/MS methods to determine environmental factors on fetal and newborn gene expression Instruction	New
203890	LOI2-BIO-19 - Integration of salivary analytes into the NCS: Evaluation of Feasibility, Efficiency, and Benefits Form and Instruction	New
201426	Methods of Biospecimen Collection for Women, Infants and Children Instruction	New

ICR Details

OMB Control No: 0925-0647	ICR Reference No: 201109-0925-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Biospecimen and Physical Measurements Formative Research Methodology Studies for the National Children?s Study (NICHD)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 01/05/2012
	Date Received in OIRA: 09/07/2011
Terms of Clearance: NIH must submit each project/IC to OMB for approval under the PRA prior to implementation. Submissions for each project (IC) must include all relevant information usually submitted as part of Supporting Statements Parts A and B, although an IRB protocol or contractor work plan, accompanied by a cover letter, may be submitted instead of Parts A and B, provided the substitue documents include all necessary information.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2015	36 Months From Approved
Responses	113,000	0	0
Time Burden (Hours)	60,000	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: Faced with the challenge of how to address the potential risks of many environmental factors that may be affecting the health and development of children, the President's Task Force on Health Risks and Safety Risks to Children concluded in 1999 that a large study to define the actual risks associated with broad environmental exposures is an essential first step. Following the recommendation of the task force, the U.S. Congress passed the Children's Health Act of 2000 which directed the National Institute of Child Health and Human Development (NICHD) to conduct a national longitudinal study of environmental influences (including physical, chemical, biological, and psychosocial influences) on children's health and development. The National Institute of Environmental Health Sciences (NIEHS), the Centers for Disease Control and Prevention (CDC), and the U.S. Environmental Protection Agency (EPA) joined the NICHD in planning the study.

---

Authorizing Statute(s): PL: Pub.L. 106 - 310 1004 Name of Law: The Children's 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:
	76 FR 23609	04/27/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 54474	09/01/2011
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
LOI2-BIO-19 - Integration of salivary analytes into the NCS: Evaluation of Feasibility, Efficiency, and Benefits	1.1, 2.1, 2.3, 2.4, 1.3, 2.2	Goal 2 Follow-Up Telephone Interview ,   Goal 2 Saliva Collection Log ,   Goal 1 Demographic and Health ,   Goal 2 Home Visit Demographics ,   Goal 1 Telephone Screening Script ,   Goal 2 Telephone Screening Script
LOI3-RT-01-N GC/MS methods to determine environmental factors on fetal and newborn gene expression
Methods of Biospecimen Collection for Women, Infants and Children

---

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	113,000	0	0	113,000	0	0
Annual Time Burden (Hours)	60,000	0	0	60,000	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: No

Burden Reduction Due to:

Short Statement: This is a new ICR.

---

Annual Cost to Federal Government: $600,000

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: 09/07/2011

---