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View ICR - OIRA Conclusion

OMB Control No: 0920-0010	ICR Reference No: 202405-0920-002
Status: Historical Active	Previous ICR Reference No: 202212-0920-015
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0010-24FM
Title: [NCBDDD] Birth Defects Study to Evaluate Pregnancy exposureS (BD-STEPS)
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/13/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 05/07/2024
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2026	04/30/2026	04/30/2026
Responses	6,507	0	9,097
Time Burden (Hours)	3,825	0	4,473
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	6,507	9,097	-2,590
Annual Time Burden (Hours)	3,825	4,473	-648
Annual Cost Burden (Dollars)	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: Yes

Burden Reduction Due to: Changing Forms

Short Statement: Removal of the Linkage to Reportable Infectious Disease Consent (Attachments D2 and D3), this proposed change would not impact the burden as presented in our last approved OMB package. Our previous burden estimates were calculated under the extreme situation based on 100% complete participation. Given expectations of ~ 60% participation and the proposed reduction in the text in the core computer telephone interview, we do not anticipate a change in burden to the remaining instruments even with the addition of one BD-STEPS site and one site added to stillbirth activities. Removal of the linkage to reportable infectious disease consent would reduce the total burden hours from 4,473 to 3,825.

Annual Cost to Federal Government: $3,825,876

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination. Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination. 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? No

Agency Contact: Thelma Sims 4046394771