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View ICR - OIRA Conclusion

OMB Control No: 0925-0001	ICR Reference No: 202207-0925-002
Status: Historical Active	Previous ICR Reference No: 202108-0925-001
Agency/Subagency: HHS/NIH	Agency Tracking No: 19797
Title: PHS Applications and Pre-award Related Reporting (OD)
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: 09/21/2022
Retrieve Notice of Action (NOA)	Date Received in OIRA: 07/22/2022
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2024	09/30/2024	09/30/2024
Responses	413,393	0	413,393
Time Burden (Hours)	2,023,454	0	2,023,454
Cost Burden (Dollars)	0	0	0

Authorizing Statute(s): US Code: 42 USC 300 Name of Law: Public Health Service Act
   US Code: 42 USC 286 Name of Law: Public Health Service Act
   US Code: 42 USC 216 Name of Law: Public health Service Act
   US Code: 42 USC 285 Name of Law: public Health Serice Act
   US Code: 42 USC 241 Name of Law: Public Health Service
   US Code: 42 USC 288 Name of Law: Public Health Serive Act

Citations for New Statutory Requirements: None

ICR Summary of Burden

	Total Approved	Previously Approved
Annual Number of Responses	413,393	413,393
Annual Time Burden (Hours)	2,023,454	2,023,454
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: This submission represents a program change due to a conversion of the Inclusion Enrollment Report form which is being converted to a Common form to include the Department of Defense (DoD). Also, the PHS Human Subjects and Clinical Trial Information form burden (5,030) was inadvertently listed twice. Additionally, burden (3,354) was added to the PHS Assignment Request Form line item, but it was intended to be a header. The burden estimate has now been adjusted to a difference of 126,935 hours. See SSA A.15 for description of noteworthy changes

Annual Cost to Federal Government: $238,382

Does this IC contain surveys, censuses, or employ statistical methods? No

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: Mikia Currie 3014350941