Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.

View ICR - OIRA Conclusion

OMB Control No: 0910-0669	ICR Reference No: 201908-0910-009
Status: Historical Active	Previous ICR Reference No: 201608-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: Abbreviated New Animal Drug Applications
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: 10/08/2019
Retrieve Notice of Action (NOA)	Date Received in OIRA: 09/09/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2022	36 Months From Approved	10/31/2019
Responses	51	0	33
Time Burden (Hours)	3,604	0	3,339
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	51	33	18
Annual Time Burden (Hours)	3,604	3,339	265
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: No

Burden Reduction Due to:

Short Statement: Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our previous estimate of the number of respondents submitting generic drug applications. However, as discussed, the burden for this information collection (a program change) was increased by 265 hours and 18 responses since the last OMB approval. This is due to adding to this collection burden hours and responses for biowaiver requests. We have also added to this collection a discussion of the use of veterinary master files by the animal pharmaceutical industry in support of information being submitted for NADAs, ANADAs, INAD files, and JINAD files.

Annual Cost to Federal Government: $4,995,680

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. Yes

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