Postmarketing Safety Reporting for Combination Products

Forms and Documents

Document Name	Status
ss PMSR final rule 6-26-17.doc Supporting Statement A	2017-06-26

IC Document Collections

IC ID	Document Title	Status
191027	Developing SOPs for new combination products	Removed
191026	Blood Fatality report (21 CFR 4.103(b)(5)	Removed
191025	Sharing information with consitutents	Modified
191024	Recordkeeping by device-led, drugs and biologics-led combination products; and shared records	Modified
191023	Submitting various reports	Modified
191022	5 day report (21 CFR 4.103(b)(1))	Removed

ICR Details

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

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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.

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

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AF82	Final or interim final rulemaking	81 FR 92603	12/20/2016

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Sharing information with consitutents
5 day report (21 CFR 4.103(b)(1))
Developing SOPs for new combination products
Blood Fatality report (21 CFR 4.103(b)(5)
Submitting various reports
Recordkeeping by device-led, drugs and biologics-led combination products; and shared records

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	16,668	0	0	16,668	0	0
Annual Time Burden (Hours)	12,885	0	0	12,885	0	0
Annual Cost Burden (Dollars)	0	0	0	0	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.

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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

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 06/29/2017

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