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OMB Control No: 0923-0046	ICR Reference No: 201302-0923-002
Status: Historical Active	Previous ICR Reference No: 201203-0923-003
Agency/Subagency: HHS/TSDR	Agency Tracking No: 18768
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: Approved without change	Conclusion Date: 02/14/2013
	Date Received in OIRA: 02/13/2013
Terms of Clearance: 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	02/29/2016	36 Months From Approved
Responses	7,400	0	0
Time Burden (Hours)	4,455	0	0
Cost Burden (Dollars)	0	0	0

Abstract: The Navajo Birth Cohort Study is the first prospective epidemiologic study of pregnancy and neonatal outcomes in a uranium-exposed population. The purpose of study is to quantify fetal risk from uranium exposure by recruiting Navajo mothers, assessing their uranium exposure at key developmental milestones, and following the children post-birth to evaluate any associations with birth defects or developmental delays. Additional research goals include assessing potential interactions with other heavy metals in the environment and determining activities and source contributions that lead to increased maternal/fetal uranium exposure. This will provide broad public health benefits for Navajo communities through outreach and education on the importance of prenatal care, environmental prenatal risks, and earlier assessment and referral for known developmental delays. Study partners include ATSDR, Univ. of New Mexico Community Environmental Health Program (UNM-CEHP), Navajo Area Indian Health Service (NAIHS), and Navajo Nation Division of Health (NNDOH).

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

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 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

ICR Summary of Burden

	Total Approved	Change Due to Agency Discretion
Annual Number of Responses	7,400	7,400
Annual Time Burden (Hours)	4,455	4,455
Annual Cost Burden (Dollars)	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 resubmission of a new ICR per OMB instructions.

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? 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

Agency Contact: Tony Richardson 404 639-4965 lmr7@cdc.gov

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