Postmarketing Safety Reporting for Combination Products

Forms and Documents

Document	Type	Status	Availability
0834 ss 7-20-2020.pdf	Supporting Statement A	Uploaded 2020-08-31	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
191025	Sharing information with consitutents		Modified
191024	Recordkeeping by device-led, drugs and biologics-led combination products; and shared records		Removed
191023	Submitting various reports		Removed

ICR Details

OMB Control No: 0910-0834	ICR Reference No: 202008-0910-012
Status: Active	Previous ICR Reference No: 201706-0910-021
Agency/Subagency: HHS/FDA	Agency Tracking No: CROSS CENTER
Title: Postmarketing Safety Reporting for Combination Products
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: 10/02/2020
	Date Received in OIRA: 08/31/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2023	36 Months From Approved	10/31/2020
Responses	594	0	16,668
Time Burden (Hours)	267	0	12,885
Cost Burden (Dollars)	0	0	0

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Abstract: For combination products for which the constituent parts receive marketing authorization under separate applications held by different entities, the Agency established a requirement, specific to these “constituent part applicants,” that they must share safety information they receive related to certain events with the other constituent part applicant(s), and maintain records of this information sharing.

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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:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 23971	04/30/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 47389	08/05/2020
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Submitting various reports
Recordkeeping by device-led, drugs and biologics-led combination products; and shared records
Sharing information with consitutents

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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	594	16,668	0	-16,074	0	0
Annual Time Burden (Hours)	267	12,885	0	-12,618	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: Miscellaneous Actions

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

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The burden for this extension request has decreased (an adjustment) because the burden for drug, devices and biological products has been omitted from this ICR and consolidated into the appropriate center ICRs referred to in section 1 of this document.

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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? No

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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: 08/31/2020

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