Postmarketing Safety Reporting for Combination Products

ICR 202008-0910-012

OMB: 0910-0834

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2020-08-31
ICR Details
0910-0834 202008-0910-012
Active 201706-0910-021
HHS/FDA CROSS CENTER
Postmarketing Safety Reporting for Combination Products
Extension without change of a currently approved collection   No
Regular
Approved without change 10/02/2020
Retrieve Notice of Action (NOA) 08/31/2020
  Inventory as of this Action Requested Previously Approved
10/31/2023 36 Months From Approved 10/31/2020
594 0 16,668
267 0 12,885
0 0 0

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.

US Code: 21 USC 353 Name of Law: FFDCA
  
None

Not associated with rulemaking

  85 FR 23971 04/30/2020
85 FR 47389 08/05/2020
No

  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
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
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.

$0
No
    No
    No
No
No
No
No
Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@fda.hhs.gov

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
08/31/2020


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