Prospective Birth Cohort Study Involving Environmental Uranium Exposure in the Navajo Nation

Forms and Documents

Document Name	Status
Home Environmental Assessment Form and Instruction	Modified
Eligibility Screener Form	Modified
Postpartum Survey - 6, 9, 12 months Form	Modified
Postpartum Survey - 2 months Form	Modified
Food Frequency Questionnaire Form	Modified
Mullen Stages of Early Development Form	Modified
Ages and Stages Questionnaire Form	Modified
Enrollment Survey - father Form	Modified
Enrollment Survey - mother Form	Modified
Att4 Study Info-Timeline 20151124.pdf Supplementary Document	2015-11-30
0923-0046 Navajo_SSB_extension 20151124.docx Supporting Statement B	2015-11-30
0923-0046 Navajo_SSA_extension 20151124.docx Supporting Statement A	2015-11-30
Att9 Med Recd Abstrn Table & Form.pdf Supplementary Document	2015-11-23
Att17 Biomn Env Home Assmnt Rprt Ltrs.docx Supplementary Document	2015-11-23
Att16 Biomonitoring SOPs.pdf Supplementary Document	2015-11-23
Att15 BiomonitTable&Just.docx Supplementary Document	2015-11-23
Att14 Recruit Posters Brochure.pdf Supplementary Document	2015-11-23
Att13 Survey Question Sources.docx Supplementary Document	2015-11-23
Att12 Consent HIPAA Forms.docx Supplementary Document	2015-11-23
Att11 IRB Approval 20151116.pdf Supplementary Document	2015-11-23
Att10 Data Security & Privacy Protocols.pdf Supplementary Document	2015-11-23
Att7 Timeline of Engagement.docx Supplementary Document	2015-11-23
Att6 OutrchChron.pdf Supplementary Document	2015-11-23
Att5 Individuals Consult.docx Supplementary Document	2015-11-23
Att3 DevelAsst Manual.pdf Supplementary Document	2015-11-23
Att2a Public Comment.pdf Supplementary Document	2015-11-23
Att2 60-day FRN 2015-24718.pdf Supplementary Document	2015-11-23
Att1 AuthLegislation.docx Supplementary Document	2015-11-23

IC Document Collections

IC ID	Document Title	Status
205767	Home Environmental Assessment Form and Instruction	Modified
201792	Eligibility Screener Form	Modified
201791	Postpartum Survey - 6, 9, 12 months Form	Modified
201790	Postpartum Survey - 2 months Form	Modified
201789	Food Frequency Questionnaire Form	Modified
201788	Mullen Stages of Early Development Form	Modified
201787	Ages and Stages Questionnaire Form	Modified
201786	Enrollment Survey - father Form	Modified
201785	Enrollment Survey - mother Form	Modified

ICR Details

OMB Control No: 0923-0046	ICR Reference No: 201511-0923-001
Status: Historical Active	Previous ICR Reference No: 201305-0923-005
Agency/Subagency: HHS/TSDR	Agency Tracking No:
Title: Prospective Birth Cohort Study Involving Environmental Uranium Exposure in the Navajo Nation
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/22/2016
	Date Received in OIRA: 12/15/2015
Terms of Clearance: Previous terms of clearance apply: Approved consistent with CDC acknowledgment that the study design limits the extent to which it can determine the impacts of uranium exposure on birth outcomes and child development. As such CDC commits to: a) making sure that its contractors set realistic expectations with its study participants, including ensuring that all recruitment materials (e.g., YouTube videos and presentations at meetings) are consistent with the study goal of improving CDCs understanding of the relationship between exposures and health endpoints rather than quantifying risk, and b) clearly articulating the limitations of the study design and, accordingly, of its conclusions when disseminating the findings to its stakeholders (including other Federal agencies, Congress, and the Navajo Nation).

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2019	36 Months From Approved	02/29/2016
Responses	7,400	0	7,400
Time Burden (Hours)	4,455	0	4,455
Cost Burden (Dollars)	0	0	0

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Abstract: The Navajo Birth Cohort Study is the first prospective epidemiological study of pregnancy and neonatal outcomes in a uranium-exposed population. The purpose of the Navajo Birth Cohort Study is to quantify fetal risk from uranium exposure by recruiting Navajo mothers, assessing their uranium exposure at key developmental milestones, and then following the children post-birth to evaluate any associations with birth defects or developmental delays. As supplemental funding has been received, this is an extension request to continue data collection for an additional three years.

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Authorizing Statute(s): US Code: 42 USC 9626 Name of Law: SARA (Superfund)
   US Code: 42 USC 241 Name of Law: PHSA
   US Code: 42 USC 9604 Name of Law: CERCLA
  

Citations for New Statutory Requirements: None

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

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 58733	09/30/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 75865	12/04/2015
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 9

IC Title	Form No.	Form Name
Eligibility Screener	none	Eligibility Screener
Enrollment Survey - mother	none	Enrollment - mother
Home Environmental Assessment	none	Home Environmental Assessment
Ages and Stages Questionnaire	none	Ages and Stages Questionnaire
Mullen Stages of Early Development	none	Mullen Scales of Early Learning
Food Frequency Questionnaire	none	Food Frequency Questionnaire
Postpartum Survey - 2 months	none	Postpartum Survey - 2 months
Postpartum Survey - 6, 9, 12 months	none	Postpartum Survey - 6, 9, 12 months
Enrollment Survey - father	none	Enrollment - Father

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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	7,400	7,400	0	0	0	0
Annual Time Burden (Hours)	4,455	4,455	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $2,000,000

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? Yes

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

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Common Form ICR:  No

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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: 12/15/2015

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