View Information Collection Request (ICR) Package

Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.

View ICR - OIRA Conclusion

OMB Control No: 0910-0760	ICR Reference No: 202107-0910-016
Status: Historical Active	Previous ICR Reference No: 201911-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: ORA
Title: Federal-State Regulatory Program Standards
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/08/2021
	Date Received in OIRA: 10/04/2021
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2024	36 Months From Approved	02/28/2023
Responses	134	0	34
Time Burden (Hours)	24,346	0	19,346
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	134	34	100
Annual Time Burden (Hours)	24,346	19,346	5,000
Annual Cost Burden (Dollars)	0	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 information collection request reflects a program change revision. The total estimated burden of this collection has increased by 5,000 burden hours, from 19,346 to 24,346 burden hours. Based on our experience with similar information collection, we estimate an initial 10 respondents will participate in the Egg Regulatory Program Standards (ERPS), and assume an average of 50 burden hours per response is necessary for the attendant recordkeeping and submission of data elements to FDA. We expect participation in the ERPS to increase. Finally, upon submission of the Information Collection Request, we are correcting an inadvertent calculation error in the total burden hours as displayed on page 26530, in Table 1, in our 60-day notice in the Federal Register of May 14, 2021 (86 FR 26528).

Annual Cost to Federal Government: $300,000

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. No

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. 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? No

Agency Contact: Rachel Showalter 202 693-2146 Showalter.Rachel@dol.gov

Something went wrong when downloading this file. If you have any questions, please send an email to risc@gsa.gov.