View Information Collection Request (ICR) Package

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 Generic ICR - OIRA Conclusion

OMB Control No: 0910-0695	ICR Reference No: 201712-0910-001
Status: Historical Active	Previous ICR Reference No: 201711-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Data to Support Drug Product Communications
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: 02/14/2018
Retrieve Notice of Action (NOA)	Date Received in OIRA: 12/28/2017
Terms of Clearance: Prior terms remain in effect. This generic clearance for FDA/CDER is approved for 3 years under the following conditions: (1) For individual "tests," FDA shall submit a generic IC in ROCIS along with: (a) an abbreviated supporting statement in the template agreed to by OMB and FDA (including a statement of need, intended use of information, description of respondents, date(s) and location(s), collection procedures, justification for any proposed incentive, etc.); (b) participant screeners, and (c) instruments/moderator guides. (2) OMB will respond with clearance or questions within 10 working days.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2021	36 Months From Approved	02/28/2018
Responses	43,875	0	35,603
Time Burden (Hours)	9,620	0	9,625
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	43,875	35,603	8,272
Annual Time Burden (Hours)	9,620	9,625	-5
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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: There are no program changes to the information collection. However, we have made adjustments to the burden hours and annual responses in keeping with the approval of a recent change request and previous burden approval. Thus the information collection reflects an increase to 43,875 in annual responses and a decrease to 9,620 total hours.

Annual Cost to Federal Government: $2,209,708

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