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View ICR - OIRA Conclusion

OMB Control No: 0910-0572	ICR Reference No: 202408-0910-009
Status: Active	Previous ICR Reference No: 202202-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Labeling Requirements for Human Prescription Drug and Biological Products
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 07/31/2025
Retrieve Notice of Action (NOA)	Date Received in OIRA: 01/31/2025
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2028	36 Months From Approved	07/31/2025
Responses	433,324	0	433,323
Time Burden (Hours)	1,913,896	0	1,913,864
Cost Burden (Dollars)	0	0	129,150

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	433,324	433,323	1
Annual Time Burden (Hours)	1,913,896	1,913,864	32
Annual Cost Burden (Dollars)	0	129,150	-129,150

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: The information collection reflects nominal adjustments that include the addition of one response and 32 hours annually, and we have removed costs previously attributable to respondents publicly posting safety labeling changes which we believe is now usual and customary practice. At the same time, we have clarified the scope of activity announcing in our notice OMB approved-modifications since last review (changes approving the addition of recommendations found in guidance; burden associated with Strategic National Stockpile labeling; bar code exemptions; and hypertension claims) and invited public comment. Although no comments were received as discussed in Q-8, we characterized the renewal request as a revision.

Annual Cost to Federal Government: $41,785,141

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: Domini Bean 301 796-5733 domini.bean@fda.hhs.gov