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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

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.

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

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 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

ICR Summary of Burden

	Total Approved	Previously Approved
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: No

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement:

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

Agency Contact: Shari Steinberg 404 639-4942 shari.steinberg@cdc.hhs.gov

View ICR - OIRA Conclusion