View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0688	ICR Reference No: 202305-0910-005
Status: Active	Previous ICR Reference No: 202010-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Time and Extent Applications for Nonprescription Drug Products
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: 01/16/2024
	Date Received in OIRA: 12/14/2023
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2027	36 Months From Approved	01/31/2024
Responses	1	0	9
Time Burden (Hours)	862	0	7,756
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute
Annual Number of Responses	1	9	-8
Annual Time Burden (Hours)	862	7,756	-6,894
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: No

Burden Reduction Due to:

Short Statement: As a result of the statutory provision, we anticipate no TEA submissions. For purposes of burden calculation, we assume one respondent as a placeholder. Our estimated burden for the information collection reflects, as a result of the statutory provision, a program change decrease of 6,894 hours and a corresponding decrease of 8 responses.

Annual Cost to Federal Government: $1,146

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

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