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

Forms and Documents

Document Name	Status
Eligibility Screener Form	New
Postpartum Survey - 12 months Form	New
Postpartum Survey - 2,6,9 months Form	New
Postpartum Survey - 0 months Form	New
Mullen Scales of Early Development Form	New
Ages and Stages Questionnaire Form	New
Enrollment for Fathers Form	New
Enrollment for Mothers Form	New
Navajo_Supp Stmt_B_3-08-12.docx Supporting Statement B	2012-03-26
Attach#12_Dvl Assess Manl_Feedbk Frm.pdf Supplementary Document	2012-03-26
Attach#11_Letters of Support.pdf Supplementary Document	2012-03-26
Attach#10_Recrt PostersBrochTemplates_2-29-12.pdf Supplementary Document	2012-03-26
Attach#9_Timeline Interact.doc Supplementary Document	2012-03-26
Attach#8_CommOutrchChron.pdf Supplementary Document	2012-03-26
Attach#7_IndvConsult 2-27-12.doc Supplementary Document	2012-03-26
Attach#6_Study Info_ParticipTimeline 2-29-12.pdf Supplementary Document	2012-03-26
Attach#5_ IRB.pdf Supplementary Document	2012-03-26
Attach#4_ConsentHIPPA.pdf Supplementary Document	2012-03-26
Attach#2_60 Day Published FRN.pdf Supplementary Document	2012-03-26
Attach#1_Auth_Legis.doc Supplementary Document	2012-03-26
Navajo_Supp Stmt A_3-08-12.docx Supporting Statement A	2012-03-26

IC Document Collections

IC ID	Document Title	Status
201792	Eligibility Screener Form	New
201791	Postpartum Survey - 12 months Form	New
201790	Postpartum Survey - 2,6,9 months Form	New
201789	Postpartum Survey - 0 months Form	New
201788	Mullen Scales of Early Development Form	New
201787	Ages and Stages Questionnaire Form	New
201786	Enrollment for Fathers Form	New
201785	Enrollment for Mothers Form	New

ICR Details

OMB Control No: 0923-0046	ICR Reference No: 201203-0923-003
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/TSDR	Agency Tracking No:
Title: Prospective Birth Cohort Study Involving Environmental Uranium Exposure in the Navajo Nation
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OIRA Conclusion Action: Withdrawn	Conclusion Date: 02/04/2013
	Date Received in OIRA: 03/30/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Navajo Nation is the largest Alaska Native/American Indian Reservation in the US. From 1948 to 1986, many uranium mining and milling operations took place in the Navajo Nation, leaving a large amount of uranium contamination. The Indian Health Service reported in 2003 that the infant death rate among the Navajo people is 8.5 deaths/1000 live births, compared to 6.9 deaths/1000 live births among all races in the US. The House Committee on Oversight and Government Reform requested federal agencies develop a plan to address health and environmental impacts of this contamination. ATSDR and other Federal, state, and Navajo partners propose to study the reproductive outcomes in pregnant Navajo women, follow and assess their children from birth to 1 year of age, and create a system to follow the infants up to 6 years of age to evaluate the impact of uranium exposure on biological and psychosocial endpoints.

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

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:
	76 FR 72206	11/22/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 18248	03/27/2012
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 8

IC Title	Form No.	Form Name
Enrollment for Mothers	none	Mother's Enrollment
Enrollment for Fathers	none	Father's Enrollment
Ages and Stages Questionnaire	none	Ages and Stages
Mullen Scales of Early Development	none	Mullen Scales of Early Development
Postpartum Survey - 0 months	none	Postpartum Survey - 0 months
Postpartum Survey - 2,6,9 months	none	Postpartum Survey - 2, 6, 9 months
Postpartum Survey - 12 months	none	Postpartum Survey - 12 months
Eligibility Screener	none	Eligibility Screener

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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.

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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: 03/30/2012

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