Factors Influencing Children's Potential Exposures to Indoor Contaminants

Forms and Documents

Document Name	Status
Household Inventory Form	New
Questionnaire about Index Child Form	New
Questionnaire about Sibling of Index Child Form	New
Participant Instruction and Record Book Form and Instruction	New
AppndxG Assent Form 20151223.doc Supplementary Document	2016-03-16
AppndxE Flow chart recruitment sample collection.docx Supplementary Document	2016-03-16
AppndxH IRB Approval Letters 20160226.docx Supplementary Document	2016-03-16
AppndxF Consent Form 20151223.docx Supplementary Document	2016-03-16
AppndxC Research Protocol.docx Supplementary Document	2016-03-16
Appendix B (60 day FRN GHS).pdf Supplementary Document	2015-08-17
APPENDIX A (Authorizing Legislation and Other Relevant Laws).doc Supplementary Document	2015-08-17
SSB GHS Add-on 20160304.docx Supporting Statement B	2016-03-16
SSA GHS Add-on 20160304.docx Supporting Statement A	2016-03-16

IC Document Collections

IC ID	Document Title	Status
220647	Household Inventory Form	New
220646	Questionnaire about Index Child Form	New
220645	Questionnaire about Sibling of Index Child Form	New
220644	Preparation and Collection of Data other than Biospecimens Instruction	New
220643	Biospecimen Collection from Children Instruction	New
220642	Participant Instruction and Record Book Form and Instruction	New

ICR Details

OMB Control No: 0920-1107	ICR Reference No: 201508-0920-005
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 15AFJ
Title: Factors Influencing Children's Potential Exposures to Indoor Contaminants
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: 03/18/2016
	Date Received in OIRA: 08/21/2015
Terms of Clearance: Approved consistent with the understanding that the purpose of this data collection is methodological. The parameters of study’s sample design (i.e., convenience sampling and small sample size), do not permit generalizations about differences in the presence of allergens, toxic substances, or biomarkers between “green”-built and “non-green” standard built low income housing. As discussed the supporting materials for OMB Control No: 0920-0906, the full Green Housing Study clearance, all 13 sites (325 subjects/study arm) are necessary to provide adequate statistical power for comparisons of environmental measurements in green vs. non green housing.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2019	36 Months From Approved
Responses	528	0	0
Time Burden (Hours)	454	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: This study will apply novel approaches to study exposures to various indoor pollutants for children. Data will be used to characterize personal, housing, and community factors influencing children's potential exposures to indoor contaminants at different life stages. Methods include a time- activity questionnaire and accelerometer, environmental samples, and biological samples and clinical measurements.

---

Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Public Health Service Act
  

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:
	80 FR 26055	05/06/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 49236	08/17/2015
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Questionnaire about Sibling of Index Child	none	Sigling Questionnaire
Participant Instruction and Record Book	none	Participant Instruction Record Book
Biospecimen Collection from Children
Preparation and Collection of Data other than Biospecimens
Questionnaire about Index Child	none	Index Child Questionnaire
Household Inventory	none	Household Inventory

---

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	528	0	0	528	0	0
Annual Time Burden (Hours)	454	0	0	454	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: ICR has been reworked per OMB instructions, resulting in a burden increase and additional ICs. This is a new ICR.

---

Annual Cost to Federal Government: $476,333

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: 08/21/2015

---