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OMB Control No: 0910-0834	ICR Reference No: 200910-0910-001
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Postmarketing Safety Reporting for Combination Products
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule	Conclusion Date: 01/26/2010
	Date Received in OIRA: 10/16/2009
Terms of Clearance: OMB is filing comment on this ICR which is associated with a proposed rule. Approval is not granted at this time. FDA should resubmit this ICR in conjunction with the final rule. At that time, FDA will consider public comments and estimate the number of respondents who will avail themselves of the streamlined reporting requirements proposed in the rule for combination products. Accordingly, FDA will revise its estimates of the consequent reduction in reporting and recordkeeping burden currently allocated to separate information collection requests (i.e. OMB control numbers 0910-0001, 0910-0230, 0910-0291, 0910-0308, 0910-0116, and 0910-0437).

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

Abstract: To ensure appropriate ongoing postmarketing surveillance of risks, to ensure the consistency of the agency's postmarketing regulation of combination products, to streamline requirements for reporters by avoiding duplicative reporting requirements, FDA proposes to create 21 CFR part 4, subpart B to clarify postmarketing safety reporting requirements for combination products.

Authorizing Statute(s): US Code: 21 USC 353 Name of Law: FFDCA

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AF82	Proposed rulemaking	74 FR 50744	10/01/2009

Federal Register Notices & Comments
Did the Agency receive public comments on this ICR? No

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: FDA proposes to create 21 CFR part 4, subpart B to clarify postmarketing safety reporting requirements for combination products.

Annual Cost to Federal Government: $0

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

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: Jonnalynn Capezzuto 3018274659

View ICR - OIRA Conclusion