View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0154	ICR Reference No: 202007-0910-011
Status: Historical Active	Previous ICR Reference No: 201707-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: Good Manufacturing Practice Regulations for Type A Medicated Articles, 21 CFR Part 226
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/24/2020
	Date Received in OIRA: 07/22/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2023	36 Months From Approved	08/31/2020
Responses	16,900	0	85,150
Time Burden (Hours)	89,050	0	89,050
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	16,900	85,150	-68,250
Annual Time Burden (Hours)	89,050	89,050	0
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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: No adjustments or program changes are reported. The decrease in annual number of responses is due to the way the ICR was entered into ROCIS--five ICs were decreased to one.

Annual Cost to Federal Government: $35,441

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: Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@fda.hhs.gov

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