View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0688	ICR Reference No: 201706-0910-015
Status: Historical Active	Previous ICR Reference No: 201405-0910-020
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded
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: 11/14/2017
	Date Received in OIRA: 08/23/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2020	36 Months From Approved	11/30/2017
Responses	9	0	4
Time Burden (Hours)	7,756	0	7,750
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	9	4	5
Annual Time Burden (Hours)	7,756	7,750	6
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: The information collection reflects an additional 6 hours of burden and 5 annual responses. By final rule of November 23, 2016 (81 FR 84465), FDA revised the TEA regulations to establish timelines and performance metrics for review of non-sunscreen TEAs, and safety and effectiveness data submissions, as required by the Sunscreen Innovation Act. We itemized these regulations and the corresponding burden estimate in both our 60-day and 30-day notices, and in Q12. of this supporting statement. We have consolidated, however, the individual provisions as they appear to the reader at www.reginfo.gov.

Annual Cost to Federal Government: $0

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? Uncollected

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

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