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OMB Control No: 0910-0834	ICR Reference No: 201706-0910-021
Status: Historical Active	Previous ICR Reference No: 200910-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: Cross center
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: Approved without change	Conclusion Date: 09/18/2017
	Date Received in OIRA: 06/29/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2020	36 Months From Approved
Responses	16,668	0	0
Time Burden (Hours)	12,885	0	0
Cost Burden (Dollars)	0	0	0

Abstract: The final rule on postmarketing safety reporting (PMSR) requirements for combination products (products composed of two or more different types of medical products, e.g., a drug and device or biologic and a drug, referred to as “constituent parts” of the combination product) clarifies and streamlines the PMSR requirements for drugs, devices, and biologics that apply to combination products. If there is a single “combination product applicant” for the product, the rule requires that applicant only to comply with the PMSR requirements associated with the product’s application type and with those additional PMSR requirements specified in the rule from among those associated with the constituent part(s) of the combination product. The rule also enables these applicants to satisfy multiple PMSR requirements through a single report. If the constituent parts of a combination product are separately distributed under separate applications, there may be a separate “constituent part applicant” for each of these constituent parts (as opposed to a single “combination product applicant” for the whole product). Constituent part applicants must comply only with the PMSR requirements associated with the application types for their respective constituent parts. In addition, they must share with one another the initial information they receive about any serious adverse event associated with the combination product. In these ways, the rule ensures effective reporting for, and responses to, postmarketing safety events for combination products while avoiding unnecessary burden to the application holders for these 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	Final or interim final rulemaking	81 FR 92603	12/20/2016

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

ICR Summary of Burden

	Total Approved	Change Due to Agency Discretion
Annual Number of Responses	16,668	16,668
Annual Time Burden (Hours)	12,885	12,885
Annual Cost Burden (Dollars)	0	0

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: This is a new information collection.

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

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