View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0906	ICR Reference No: 202406-0910-006
Status: Active	Previous ICR Reference No: 202205-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases - FINAL RULE
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 02/28/2025
	Date Received in OIRA: 07/03/2024
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/29/2028	36 Months From Approved
Responses	1,121,083	0	0
Time Burden (Hours)	478,135	0	0
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	1,121,083	1,121,083
Annual Time Burden (Hours)	478,135	478,135
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 is a new information collection request. The rulemaking introduces new information collections totaling 1,121,083 responses and 478,135 hours annually, a slightly upward adjustment from estimates in our proposed rule. We expect most of the burden to remain in OMB control no. 0910-0906, established to support this rulemaking and regulatory requirements in 21 CFR new parts 213 and 230; while we expect recurring burden attributable to the labeling of medical gases to be included in OMB control no. 0910-0572. The rule provides for an 18-month compliance period.

Annual Cost to Federal Government: $20,522

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

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