View Information Collection Request (ICR) Package

OMB Control No: 0910-0338	ICR Reference No: 201311-0910-007
Status: Historical Active	Previous ICR Reference No: 201006-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: 20859
Title: General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, and Forms FDA 356h & 2567
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: 01/03/2014
Retrieve Notice of Action (NOA)	Date Received in OIRA: 11/13/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2017	36 Months From Approved	01/31/2014
Responses	28,805	0	20,081
Time Burden (Hours)	324,761	0	341,697
Cost Burden (Dollars)	0	0	0

Abstract: Manufacturers are required to submit a license application for review and approval prior to marketing a biological product in interstate commerce. In addition, manufacturers must submit to FDA advertising and promotional labeling. Manufacturers are also required to sbumit changes, including labeling, changes to an approved application, as well as advertising and promotional labeling changes. The information submitted to FDA in a biologics license application (BLA), supplement to an approved application, or other similar submission is used to determin if a product is safe, effective, and not misbranded under prescribed, recommended, or suggested conditions of use. Forms FDA 356h and 3567 have been developed for use by the industry to insure that all the required and necessary information concerning licensing and labeling is submitted to FDA. The regulations also describe the types of postmarketing studies that reuqire status reports, the information to be included in the reports, and the type of information that FDA would consider appropriate for public disclosure. FDA uses the information submitted from the reports of postmarketing studies to meet its reporting obligations under section 506B of the Federal Food, Drug, and Comsetic Act and section 130(b) of the Food and Drug Administration Modernization Act and corresponding regulations.

Authorizing Statute(s): US Code: 42 USC 262 Name of Law: PHS Act
US Code: 21 USC 356b Name of Law: FFDCA

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 35273	06/12/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 65334	10/31/2013
Did the Agency receive public comments on this ICR? No

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	28,805	20,081	8,724
Annual Time Burden (Hours)	324,761	341,697	-16,936
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 previous burden estimate for 0910-0338 was 341,697. The slight overall decrease in burden to 324,758.60 (-16,938) is attibuted to the normal variation in the various submissions to FDA. A third party disclosure chart was added for a reporting element (i.e., notification of selling agents and distributors) under section 601.6(a) although there was no burden impact since it was previously included under the reporting burden chart. In addition, OMB Control Number 0910-0666 (section 610.15(d)) is being consolidated into this package (1 burden hour).

Annual Cost to Federal Government: $17,573,130

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: ILa Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov

View ICR - OIRA Conclusion